Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT05109702
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2021-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'parksm@hanall.co.kr', 'phone': '82-222041763', 'title': 'Project Manager', 'organization': 'Hanall Biopharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Placebo Run-in arm: From enrollment up to Day 14 of Placebo Run-in Period 0.25% Tanfanercept Ophthalmic Solution arm and Placebo arm: From first dose up to Week 8 of Treatment Period', 'description': 'Placebo Run-in arm: All the enrolled participants were included.\n\n0.25% Tanfanercept Ophthalmic Solution arm and Placebo arm: Safety population included all randomized participants who received at least one dose of the investigational product.\n\nPlacebo Run-in arm reports all AEs; 0.25% Tanfanercept Ophthalmic Solution arm and Placebo arm reports TEAEs.\n\nTreatment emergent AEs (any event that occurred or worsened on or after the day the randomized study treatment was initiated) were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Run-in', 'description': 'Participants self-administered placebo ocular drops BID in both eyes for 14 days in the Placebo Run-in Period.', 'otherNumAtRisk': 260, 'deathsNumAtRisk': 260, 'otherNumAffected': 7, 'seriousNumAtRisk': 260, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 42, 'seriousNumAtRisk': 130, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 39, 'seriousNumAtRisk': 130, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eyelid haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Macular fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Instillation site lacrimation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Instillation site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Conjunctival abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Procedural dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Noninfective gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Follicular lymphoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vulvovaginal burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acrochordon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Neuromyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.40', 'spread': '0.497', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '0.477', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.812', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '0.806', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.764', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.214', 'ciUpperLimit': '0.157', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'groupDescription': 'The Least Square (LS) means, LS mean difference, Standard Errors (SEs), two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the Mixed model repeated measures (MMRM) model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 57 (Week 8)', 'description': 'CCSS was graded using the Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale. The Ora Calibra® Corneal and Conjunctival Staining Scale ranged 0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe; lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.1', 'spread': '22.95', 'groupId': 'OG000'}, {'value': '60.8', 'spread': '25.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.19', 'spread': '30.625', 'groupId': 'OG000'}, {'value': '-19.79', 'spread': '26.317', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.144', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.34', 'ciLowerLimit': '-1.483', 'ciUpperLimit': '10.155', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.969', 'groupDescription': 'The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 57 (Week 8)', 'description': 'Eye dryness score was scored on a Visual Analogue Scale (VAS) that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).', 'unitOfMeasure': 'percentage of dryness', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.649', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.667', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.814', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.723', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.788', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '0.861', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.812', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '0.806', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.005', 'ciUpperLimit': '0.363', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.010', 'ciUpperLimit': '0.359', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.328', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.093', 'ciUpperLimit': '0.279', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.095', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.837', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.208', 'ciUpperLimit': '0.168', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.096', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.572', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.639', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.805', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.705', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.731', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.753', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.747', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.729', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.686', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.123', 'ciUpperLimit': '0.187', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.079', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.680', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.123', 'ciUpperLimit': '0.188', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.079', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.529', 'groupIds': ['OG000'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.107', 'ciUpperLimit': '0.207', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.080', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.745', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.132', 'ciUpperLimit': '0.185', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.081', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.611', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.684', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.732', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.729', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.756', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.770', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.708', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.892', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.765', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.141', 'ciUpperLimit': '0.192', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.085', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.002', 'ciUpperLimit': '0.331', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.085', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.552', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.117', 'ciUpperLimit': '0.219', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.086', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.593', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.216', 'ciUpperLimit': '0.124', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.087', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.742', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.749', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.870', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.785', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.875', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.756', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.746', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.827', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.884', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.183', 'ciUpperLimit': '0.158', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.087', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.474', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.109', 'ciUpperLimit': '0.233', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.087', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.202', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.060', 'ciUpperLimit': '0.285', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.088', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '0.047', 'ciUpperLimit': '0.396', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.089', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.703', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.700', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.860', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.797', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.817', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.822', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.829', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.879', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.604', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.131', 'ciUpperLimit': '0.224', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.090', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.519', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.119', 'ciUpperLimit': '0.236', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.091', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.299', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.085', 'ciUpperLimit': '0.275', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.092', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.039', 'ciUpperLimit': '0.324', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.093', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.78', 'spread': '1.370', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '1.585', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.76', 'spread': '1.929', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '1.750', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.94', 'spread': '1.877', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '1.976', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.52', 'spread': '1.904', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '2.049', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.293', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-0.196', 'ciUpperLimit': '0.647', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.215', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.094', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '-0.062', 'ciUpperLimit': '0.783', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.215', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.404', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.245', 'ciUpperLimit': '0.608', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.217', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.806', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.485', 'ciUpperLimit': '0.377', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.220', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12, and lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '1.219', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '1.184', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.31', 'spread': '1.582', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '1.371', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '1.463', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '1.352', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'spread': '1.427', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '1.510', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.824', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.273', 'ciUpperLimit': '0.343', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.186', 'ciUpperLimit': '0.431', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.193', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.105', 'ciUpperLimit': '0.519', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.159', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '0.048', 'ciUpperLimit': '0.679', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.161', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for conjunctival regions was derived the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.07', 'spread': '2.104', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '2.395', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.07', 'spread': '3.125', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '2.672', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.30', 'spread': '2.974', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '2.956', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.92', 'spread': '2.931', 'groupId': 'OG000'}, {'value': '-2.12', 'spread': '3.234', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.430', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.386', 'ciUpperLimit': '0.907', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.329', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.143', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '-0.164', 'ciUpperLimit': '1.132', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.330', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.245', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.267', 'ciUpperLimit': '1.042', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.333', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.359', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-0.352', 'ciUpperLimit': '0.970', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.337', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, temporal, and nasal regions. Total score ranged between 0 to 20, and lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.663', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.672', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.549', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.579', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.616', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.624', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.602', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.628', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '0.030', 'ciUpperLimit': '0.292', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.067', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.099', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.021', 'ciUpperLimit': '0.242', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.067', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.493', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.086', 'ciUpperLimit': '0.179', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.068', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.987', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.133', 'ciUpperLimit': '0.135', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.068', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.800', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.523', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.721', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.576', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.674', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.549', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.592', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.656', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.655', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.109', 'ciUpperLimit': '0.173', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.072', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.826', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.157', 'ciUpperLimit': '0.125', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.072', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.861', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.155', 'ciUpperLimit': '0.130', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.073', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.556', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.101', 'ciUpperLimit': '0.187', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.073', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.789', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.797', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.766', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.741', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.606', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.802', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.700', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.889', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.527', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.116', 'ciUpperLimit': '0.226', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.087', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.077', 'ciUpperLimit': '0.418', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.087', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.920', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.164', 'ciUpperLimit': '0.181', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.088', 'groupDescription': 'Wek 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.286', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.080', 'ciUpperLimit': '0.269', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.089', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.875', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.809', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.924', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.817', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.822', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.790', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.817', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.896', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.071', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.015', 'ciUpperLimit': '0.369', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.098', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.384', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.107', 'ciUpperLimit': '0.278', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.098', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.391', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.109', 'ciUpperLimit': '0.280', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.099', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.802', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.171', 'ciUpperLimit': '0.222', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.100', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.735', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.781', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.962', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.699', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.775', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.896', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.926', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '1.044', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.884', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.206', 'ciUpperLimit': '0.178', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.098', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.303', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.091', 'ciUpperLimit': '0.293', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.098', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.554', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.135', 'ciUpperLimit': '0.253', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.099', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.001', 'ciUpperLimit': '0.391', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.100', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '1.622', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '1.526', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'spread': '1.395', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '1.445', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.74', 'spread': '1.334', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '1.516', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.69', 'spread': '1.344', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '1.691', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.131', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.077', 'ciUpperLimit': '0.591', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.170', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0.016', 'ciUpperLimit': '0.685', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.171', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.767', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.287', 'ciUpperLimit': '0.389', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.410', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.198', 'ciUpperLimit': '0.485', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.174', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12,and lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '1.397', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '1.261', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '1.600', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '1.307', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '1.348', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '1.488', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '1.537', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '1.717', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.324', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.166', 'ciUpperLimit': '0.501', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.170', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.262', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.143', 'ciUpperLimit': '0.525', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.170', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.391', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.190', 'ciUpperLimit': '0.485', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.192', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-0.114', 'ciUpperLimit': '0.568', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.174', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for conjunctival regions was derived as the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '2.634', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '2.252', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '2.618', 'groupId': 'OG000'}, {'value': '-1.35', 'spread': '2.277', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.16', 'spread': '2.262', 'groupId': 'OG000'}, {'value': '-1.33', 'spread': '2.507', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.95', 'spread': '2.364', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '2.912', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.140', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-0.141', 'ciUpperLimit': '0.999', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.290', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.061', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-0.025', 'ciUpperLimit': '1.117', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.291', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.490', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.374', 'ciUpperLimit': '0.780', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.294', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.212', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-0.212', 'ciUpperLimit': '0.953', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.297', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, nasal, and temporal regions. Total score ranged between 0 to 20, and lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.450', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.519', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.435', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.456', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.577', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.534', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.648', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '0.544', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.784', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.134', 'ciUpperLimit': '0.101', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.060', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.324', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.058', 'ciUpperLimit': '0.176', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.060', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.130', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.027', 'ciUpperLimit': '0.210', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.060', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.110', 'ciUpperLimit': '0.350', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.061', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'It was evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.69', 'spread': '5.155', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '4.361', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.24', 'spread': '5.858', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '4.972', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.45', 'spread': '5.913', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '4.257', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.532', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.834', 'ciUpperLimit': '1.613', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.623', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.252', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '-0.515', 'ciUpperLimit': '1.959', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.630', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '0.732', 'ciUpperLimit': '3.231', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.636', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 2, 4, and 8', 'description': 'The Schirmer test strip was placed in the lower temporal lid margin of each eye. Participants were instructed to close their eyes and after 5 minutes had elapsed, the length of moistened area of schirmer strip was recorded (millimeter \\[mm\\]) for each eye.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '1.643', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '1.513', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '1.168', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '1.171', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '1.064', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '1.600', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '1.548', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '1.226', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.723', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.386', 'ciUpperLimit': '0.268', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.167', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.254', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.519', 'ciUpperLimit': '0.137', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.167', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.690', 'ciUpperLimit': '-0.028', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.169', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.640', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.255', 'ciUpperLimit': '0.414', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.171', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Sodium fluorescein solution was instilled into each eye and participants were instructed to blinked several times. The time it took to form micelles from the time that the eye is opened was noted.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.49', 'spread': '27.712', 'groupId': 'OG000'}, {'value': '-5.43', 'spread': '21.630', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.74', 'spread': '26.961', 'groupId': 'OG000'}, {'value': '-9.66', 'spread': '23.478', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.84', 'spread': '29.437', 'groupId': 'OG000'}, {'value': '-9.04', 'spread': '22.261', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.17', 'spread': '28.441', 'groupId': 'OG000'}, {'value': '-11.82', 'spread': '22.174', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.615', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '-4.223', 'ciUpperLimit': '7.133', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.893', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.'}, {'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.81', 'ciLowerLimit': '-0.866', 'ciUpperLimit': '10.494', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.894', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.718', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '-4.690', 'ciUpperLimit': '6.810', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.930', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.298', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.09', 'ciLowerLimit': '-2.728', 'ciUpperLimit': '8.903', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.963', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of burning/stinging by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).', 'unitOfMeasure': 'percentage of burining/stinging', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.63', 'spread': '23.060', 'groupId': 'OG000'}, {'value': '-4.06', 'spread': '23.349', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.93', 'spread': '23.489', 'groupId': 'OG000'}, {'value': '-8.26', 'spread': '22.783', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.83', 'spread': '25.806', 'groupId': 'OG000'}, {'value': '-6.90', 'spread': '22.919', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.81', 'spread': '30.745', 'groupId': 'OG000'}, {'value': '-11.58', 'spread': '25.182', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.343', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.67', 'ciLowerLimit': '-2.854', 'ciUpperLimit': '8.191', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.814', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.188', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.71', 'ciLowerLimit': '-1.813', 'ciUpperLimit': '9.232', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.814', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.371', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.55', 'ciLowerLimit': '-3.040', 'ciUpperLimit': '8.143', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.849', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.92', 'ciLowerLimit': '1.259', 'ciUpperLimit': '12.573', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.883', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of foreign body sensation by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).', 'unitOfMeasure': 'percentage of foreign body sensation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.49', 'spread': '21.885', 'groupId': 'OG000'}, {'value': '-5.52', 'spread': '20.820', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.39', 'spread': '23.746', 'groupId': 'OG000'}, {'value': '-9.07', 'spread': '21.807', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.31', 'spread': '23.372', 'groupId': 'OG000'}, {'value': '-9.78', 'spread': '22.738', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.12', 'spread': '27.650', 'groupId': 'OG000'}, {'value': '-14.33', 'spread': '21.512', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.754', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '-4.452', 'ciUpperLimit': '6.147', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.700', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.368', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.43', 'ciLowerLimit': '-2.865', 'ciUpperLimit': '7.731', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.700', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.621', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '-4.014', 'ciUpperLimit': '6.715', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.734', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.087', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.74', 'ciLowerLimit': '-0.688', 'ciUpperLimit': '10.168', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.766', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of itching by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).', 'unitOfMeasure': 'percentage of itching', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.95', 'spread': '20.483', 'groupId': 'OG000'}, {'value': '-7.53', 'spread': '18.674', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.94', 'spread': '21.564', 'groupId': 'OG000'}, {'value': '-8.61', 'spread': '22.511', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.50', 'spread': '25.051', 'groupId': 'OG000'}, {'value': '-9.49', 'spread': '22.681', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.24', 'spread': '26.069', 'groupId': 'OG000'}, {'value': '-9.46', 'spread': '23.783', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.110', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.23', 'ciLowerLimit': '-0.958', 'ciUpperLimit': '9.425', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.646', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.315', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.66', 'ciLowerLimit': '-2.535', 'ciUpperLimit': '7.855', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.647', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.318', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.67', 'ciLowerLimit': '-2.582', 'ciUpperLimit': '7.928', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.678', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. 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MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.165', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.13', 'ciLowerLimit': '-1.700', 'ciUpperLimit': '9.966', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.972', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.665', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '-4.600', 'ciUpperLimit': '7.207', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.008', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.099', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.02', 'ciLowerLimit': '-0.950', 'ciUpperLimit': '10.995', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.043', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of eye dryness by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).', 'unitOfMeasure': 'percentage of eye dryness', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.57', 'spread': '22.155', 'groupId': 'OG000'}, {'value': '-3.56', 'spread': '22.871', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.17', 'spread': '22.689', 'groupId': 'OG000'}, {'value': '-5.54', 'spread': '23.594', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.20', 'spread': '28.014', 'groupId': 'OG000'}, {'value': '-9.10', 'spread': '26.350', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.71', 'spread': '30.328', 'groupId': 'OG000'}, {'value': '-12.18', 'spread': '28.722', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.861', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '-5.232', 'ciUpperLimit': '6.254', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.926', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.548', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.76', 'ciLowerLimit': '-3.983', 'ciUpperLimit': '7.497', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.925', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.180', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.97', 'ciLowerLimit': '-1.839', 'ciUpperLimit': '9.777', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.960', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.189', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.93', 'ciLowerLimit': '-1.941', 'ciUpperLimit': '9.807', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.993', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of photophobia by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).', 'unitOfMeasure': 'percentage of photophobia', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.27', 'spread': '22.501', 'groupId': 'OG000'}, {'value': '-5.63', 'spread': '18.611', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.00', 'spread': '23.843', 'groupId': 'OG000'}, {'value': '-7.25', 'spread': '19.041', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.27', 'spread': '29.718', 'groupId': 'OG000'}, {'value': '-8.27', 'spread': '20.666', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.23', 'spread': '27.317', 'groupId': 'OG000'}, {'value': '-9.83', 'spread': '22.370', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.613', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '-3.799', 'ciUpperLimit': '6.438', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.608', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.53', 'ciLowerLimit': '-0.586', 'ciUpperLimit': '9.653', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.609', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.165', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.67', 'ciLowerLimit': '-1.508', 'ciUpperLimit': '8.851', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.639', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.110', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.28', 'ciLowerLimit': '-0.964', 'ciUpperLimit': '9.522', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.672', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of pain by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).', 'unitOfMeasure': 'percentage of pain', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.13', 'spread': '13.229', 'groupId': 'OG000'}, {'value': '-5.65', 'spread': '14.785', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.85', 'spread': '16.092', 'groupId': 'OG000'}, {'value': '-6.23', 'spread': '14.617', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.54', 'spread': '18.002', 'groupId': 'OG000'}, {'value': '-8.16', 'spread': '15.170', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.74', 'spread': '18.702', 'groupId': 'OG000'}, {'value': '-9.99', 'spread': '14.215', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.57', 'ciLowerLimit': '0.154', 'ciUpperLimit': '6.994', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.743', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.122', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.70', 'ciLowerLimit': '-0.723', 'ciUpperLimit': '6.118', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.743', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.60', 'ciLowerLimit': '1.146', 'ciUpperLimit': '8.056', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.760', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.04', 'ciLowerLimit': '0.544', 'ciUpperLimit': '7.536', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.781', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': "OSDI was a simple 12-question survey that rated the severity of the participant's dry eye disease based on the symptoms. Each question response ranged from 0 to 4, where 0 = None of the Time, 1 = Some of the Time, 2 = Half of the Time, 3 = Most of the Time, and 4 = All of the Time. 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MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.353', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.134', 'ciUpperLimit': '0.375', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.130', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.764', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.297', 'ciUpperLimit': '0.218', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.131', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.104', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.044', 'ciUpperLimit': '0.476', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.133', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'It was assessed by the Ora Calibra® ocular discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.44', 'spread': '1.304', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '1.409', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '1.277', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '1.338', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.56', 'spread': '1.477', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '1.238', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'spread': '1.511', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '1.304', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.969', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.300', 'ciUpperLimit': '0.288', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.150', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.504', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.194', 'ciUpperLimit': '0.394', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.150', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.915', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.281', 'ciUpperLimit': '0.314', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.152', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.195', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.102', 'ciUpperLimit': '0.499', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.153', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Ora Calibra® ocular discomfort \\& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.\n\nParticipants rated the severity of burning at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data will be analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '1.048', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '1.234', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.43', 'spread': '1.266', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '1.268', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'spread': '1.334', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '1.314', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.66', 'spread': '1.446', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '1.262', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.287', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.133', 'ciUpperLimit': '0.449', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.148', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.260', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.124', 'ciUpperLimit': '0.458', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.148', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.987', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.296', 'ciUpperLimit': '0.291', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.150', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.143', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.075', 'ciUpperLimit': '0.519', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.151', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Ora Calibra® ocular discomfort \\& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.\n\nParticipants rated the severity of dryness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data will be analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '1.231', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '1.278', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '1.478', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '1.293', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '1.421', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '1.214', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.58', 'spread': '1.441', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '1.302', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '-0.198', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.102', 'ciUpperLimit': '0.490', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.151', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.076', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.028', 'ciUpperLimit': '0.564', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.151', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.656', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.231', 'ciUpperLimit': '0.367', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.152', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.324', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.150', 'ciUpperLimit': '0.454', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.154', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Ora Calibra® ocular discomfort \\& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.\n\nParticipants rated the severity of grittiness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data will be analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'spread': '1.193', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '1.365', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '1.191', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '1.250', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '1.362', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '1.370', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '1.371', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '1.254', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.477', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.182', 'ciUpperLimit': '0.390', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.146', 'groupDescription': 'Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.026', 'ciUpperLimit': '0.598', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.146', 'groupDescription': 'Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.374', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.158', 'ciUpperLimit': '0.420', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.147', 'groupDescription': 'Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.114', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.056', 'ciUpperLimit': '0.529', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.149', 'groupDescription': 'Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Ora Calibra® ocular discomfort \\& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.\n\nParticipants rated the severity of stinging at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data will be analyzed'}, {'type': 'SECONDARY', 'title': 'Ora Calibra® Drop Comfort Assessment at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'classes': [{'title': 'Immediately Upon Instillation at Week 1', 'categories': [{'measurements': [{'value': '2.55', 'spread': '2.673', 'groupId': 'OG000'}, {'value': '2.72', 'spread': '2.532', 'groupId': 'OG001'}]}]}, {'title': '1 Minute Post Instillation at Week 1', 'categories': [{'measurements': [{'value': '1.95', 'spread': '2.063', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '2.174', 'groupId': 'OG001'}]}]}, {'title': '2 Minutes Post Instillation at Week 1', 'categories': [{'measurements': [{'value': '1.56', 'spread': '1.884', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '2.058', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.598', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.822', 'ciUpperLimit': '0.475', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.329', 'groupDescription': 'Immediately Upon Instillation at Week 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.343', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.783', 'ciUpperLimit': '0.273', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.268', 'groupDescription': '1 Minute Post Instillation at Week 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.359', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.721', 'ciUpperLimit': '0.262', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.250', 'groupDescription': '2 Minutes Post Instillation at Week 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'description': 'Ora Calibra® drop comfort scale ranged from 0 to 10. A score of 0 indicated comfortable and 10 indicated uncomfortable. Lower score indicated better comfort level. Immediately Upon Instillation, 1 Minute Post Instillation and 2 Minutes Post Instillation at Week 1', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Run-in', 'description': 'Participants self-administered placebo ocular drops. twice daily (BID) in both eyes for 14 days in the Placebo Run-in Period.'}, {'id': 'FG001', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}], 'periods': [{'title': 'Placebo Run-in Period (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period (8 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '116'}, {'groupId': 'FG002', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Administrative reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants who met all the eligibility criteria were enrolled at sites in the United States.', 'preAssignmentDetails': 'Participants entered the 14-day Placebo Run-in Period prior to randomization and during the 14-day period, assessments were conducted to ascertain eligibility to enter the study. Those who qualified were randomized to receive investigational product (0.25% tanfanercept ophthalmic solution or placebo) in a double-masked fashion for 8 weeks in the Treatment Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.4', 'spread': '13.31', 'groupId': 'BG000'}, {'value': '63.1', 'spread': '11.20', 'groupId': 'BG001'}, {'value': '62.7', 'spread': '12.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) Population included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-22', 'size': 33128133, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-06T22:40', 'hasProtocol': True}, {'date': '2022-02-07', 'size': 3048879, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-06T20:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'dispFirstSubmitDate': '2023-05-05', 'completionDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2021-10-27', 'resultsFirstSubmitDate': '2023-08-06', 'studyFirstSubmitQcDate': '2021-10-27', 'dispFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-19', 'studyFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Central Corneal Staining Score (CCSS) at Day 57', 'timeFrame': 'Baseline, Day 57 (Week 8)', 'description': 'CCSS was graded using the Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale. The Ora Calibra® Corneal and Conjunctival Staining Scale ranged 0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe; lower score indicated improvement.'}, {'measure': 'Change From Baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at Day 57', 'timeFrame': 'Baseline, Day 57 (Week 8)', 'description': 'Eye dryness score was scored on a Visual Analogue Scale (VAS) that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Central Region', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.'}, {'measure': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Superior Region', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.'}, {'measure': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Inferior Region', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.'}, {'measure': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Temporal Region', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.'}, {'measure': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Nasal Region', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement.'}, {'measure': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Corneal Sum', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12, and lower score indicated improvement.'}, {'measure': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Conjunctival Sum', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for conjunctival regions was derived the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.'}, {'measure': 'Change From Baseline in Fluorescein Staining at Weeks 1, 2, 4, and 8: Total Staining', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining. The score ranged from 0 to 4 (0=none and 4=severe), and lower score indicated improvement. Fluorescein total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, temporal, and nasal regions. Total score ranged between 0 to 20, and lower score indicated improvement.'}, {'measure': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Central Region', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.'}, {'measure': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Superior Region', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.'}, {'measure': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Inferior Region', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.'}, {'measure': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Temporal Region', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.'}, {'measure': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Nasal Region', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.'}, {'measure': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Corneal Sum', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal regions was derived as the sum of the reported scores for the inferior, superior, and central regions. Total score ranged between 0 to 12,and lower score indicated improvement.'}, {'measure': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Conjunctival Sum', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for conjunctival regions was derived as the sum of the reported scores for the nasal and temporal regions. Total score ranged between 0 to 8, and lower score indicated improvement.'}, {'measure': 'Change From Baseline in Conjunctival Lissamine Green Staining at Weeks 1, 2, 4, and 8 : Total Staining', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'The score for individual region was assessed by the Ora Calibra® corneal and conjunctival staining scale for grading of lissamine green staining. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Lissamine Green total staining score for corneal and conjunctival regions was derived as the sum of the reported scores for the inferior, superior, central, nasal, and temporal regions. Total score ranged between 0 to 20, and lower score indicated improvement.'}, {'measure': 'Change From Baseline in Conjunctival Redness Score at Weeks 1, 2, 4, and 8', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'It was evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.'}, {'measure': "Change From Baseline in Schirmer's Test Score at Weeks 2, 4, and 8", 'timeFrame': 'Baseline; Weeks 2, 4, and 8', 'description': 'The Schirmer test strip was placed in the lower temporal lid margin of each eye. Participants were instructed to close their eyes and after 5 minutes had elapsed, the length of moistened area of schirmer strip was recorded (millimeter \\[mm\\]) for each eye.'}, {'measure': 'Change From Baseline in Tear Film Break-up Time at Weeks 1, 2, 4, and 8', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Sodium fluorescein solution was instilled into each eye and participants were instructed to blinked several times. The time it took to form micelles from the time that the eye is opened was noted.'}, {'measure': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Burning/Stinging', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of burning/stinging by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).'}, {'measure': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Foreign Body Sensation', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of foreign body sensation by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).'}, {'measure': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Itching', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of itching by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).'}, {'measure': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Blurred Vision', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of blurred vision by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).'}, {'measure': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Eye Dryness', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of eye dryness by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).'}, {'measure': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Photophobia', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of photophobia by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).'}, {'measure': 'Change From Baseline in Visual Analogue Scale at Weeks 1, 2, 4, and 8 : Pain', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Participants rated ocular symptom of pain by placing a vertical mark on VAS that ranged from 0%-100% (0=no discomfort; 100=maximal discomfort).'}, {'measure': 'Change From Baseline in Ocular Surface Disease Index (OSDI) at Weeks 1, 2, 4, and 8', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': "OSDI was a simple 12-question survey that rated the severity of the participant's dry eye disease based on the symptoms. Each question response ranged from 0 to 4, where 0 = None of the Time, 1 = Some of the Time, 2 = Half of the Time, 3 = Most of the Time, and 4 = All of the Time. Total OSDI score = (Sum of all answered questions) \\* 25/ (number of questions answered); which ranged from 0 to 100, with higher score representing greater disability."}, {'measure': 'Change From Baseline in Ora Calibra® Ocular Discomfort Scale at Weeks 1, 2, 4, and 8', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'It was assessed by the Ora Calibra® ocular discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe), where lower score indicated improvement.'}, {'measure': 'Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Burning Discomfort', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Ora Calibra® ocular discomfort \\& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.\n\nParticipants rated the severity of burning at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.'}, {'measure': 'Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Dryness Discomfort', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Ora Calibra® ocular discomfort \\& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.\n\nParticipants rated the severity of dryness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.'}, {'measure': 'Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Grittiness Discomfort', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Ora Calibra® ocular discomfort \\& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.\n\nParticipants rated the severity of grittiness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.'}, {'measure': 'Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire at Weeks 1, 2, 4, and 8 : Stinging Discomfort', 'timeFrame': 'Baseline; Weeks 1, 2, 4, and 8', 'description': 'Ora Calibra® ocular discomfort \\& 4-symptom questionnaire for dry eye included rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging.\n\nParticipants rated the severity of stinging at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.'}, {'measure': 'Ora Calibra® Drop Comfort Assessment at Week 1', 'timeFrame': 'Week 1', 'description': 'Ora Calibra® drop comfort scale ranged from 0 to 10. A score of 0 indicated comfortable and 10 indicated uncomfortable. Lower score indicated better comfort level. Immediately Upon Instillation, 1 Minute Post Instillation and 2 Minutes Post Instillation at Week 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'referencesModule': {'references': [{'pmid': '36729473', 'type': 'DERIVED', 'citation': 'Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to compare the safety and efficacy of tanfanercept ophthalmic solution 0.25% with placebo for the treatment of the signs and symptoms of dry eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a participant-reported history of dry eye for at least 6 months prior to Visit 1\n* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1\n* Have a best-corrected visual acuity (BCVA) of 0.7 minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1\n* Report a score of ≥ 2 according to the Ora Calibra® ocular discomfort \\& 4-symptom questionnaire in at least one of the dry eye symptoms at Visits 1 and 2\n* Have a Schirmer's Test score of ≤ 10 millimeter (mm) and ≥ 1 mm in at least one eye at Visits 1 and 2\n* Have a corneal fluorescein staining score ≥ 2 according to the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining in at least 1 of the corneal regions (inferior, superior, or central) in at least 1 eye at Visits 1 and 2\n* Have a conjunctival redness score ≥ 1 according to the Ora Calibra® conjunctival redness for dry eye scale in at least 1 eye at Visits 1 and 2\n\nExclusion Criteria:\n\n* Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters\n* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1\n* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study\n* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months\n* Have used any cyclosporine-containing drops (such as Restasis®, Cequa®), or lifitegrast ophthalmic solution (Xiidra®) within 60 days of Visit 1\n* Have any previous experience using TNF inhibitor ophthalmic solutions, such Tanfanercept Ophthalmic Solution\n* Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study)\n* Be a woman who is pregnant, nursing or planning a pregnancy"}, 'identificationModule': {'nctId': 'NCT05109702', 'acronym': 'VELOS-3', 'briefTitle': 'A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'HanAll BioPharma Co., Ltd.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% Compared to Placebo in Subjects With Dry Eye', 'orgStudyIdInfo': {'id': 'HL036-DED-US-P302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Placebo Run-in', 'description': 'Participants self-administered placebo ocular drops, twice daily (BID) in both eyes for 14 days in the Placebo Run-in Period.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '0.25% Tanfanercept Ophthalmic Solution', 'description': 'Participants self-administered tanfanercept 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.', 'interventionNames': ['Drug: 0.25% Tanfanercept Ophthalmic Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants self-administered tanfanercept placebo (vehicle solution) solution as topical ophthalmic drops, BID for up to 8 weeks in Treatment Period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '0.25% Tanfanercept Ophthalmic Solution', 'type': 'DRUG', 'otherNames': ['HL036'], 'description': 'Tanfanercept ophthalmic solution.', 'armGroupLabels': ['0.25% Tanfanercept Ophthalmic Solution']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo vehicle solution.', 'armGroupLabels': ['Placebo', 'Placebo Run-in']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cornea & Cataract Consultants of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Global Research Management', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation, Inc.', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The Eye Care Institute - Butchertown Clinical Trials', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02767', 'city': 'Raynham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates: Raynham', 'geoPoint': {'lat': 41.94871, 'lon': -71.0731}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Center For Sight', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '27529', 'city': 'Garner', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Oculus Research, Inc.', 'geoPoint': {'lat': 35.71126, 'lon': -78.61417}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scott & Christie and Associates, PC', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Andover Eye Associates: Warwick', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '37072', 'city': 'Smyrna', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Advancing Vision Research, LLC.', 'geoPoint': {'lat': 35.98284, 'lon': -86.5186}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HanAll BioPharma Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}