Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-31 @ 10:54 AM
Study NCT ID:
NCT04391894
Status:
COMPLETED
Last Update Posted:
2025-01-28
First Post:
2020-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D014985', 'term': 'Xerophthalmia'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 28 days (Baseline (BL) to end of randomized treatment)', 'description': 'All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.', 'eventGroups': [{'id': 'EG000', 'title': 'ECF843 0.45 mg/mL TID (Part 1)', 'description': 'ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 9, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ECF843 0.15 mg/mL TID (Part 1)', 'description': 'ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 15, 'seriousNumAtRisk': 112, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'ECF843 Vehicle TID (Part 1)', 'description': 'ECF843 vehicle ter in die/three times a day (TID) (Part 1)', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 5, 'seriousNumAtRisk': 112, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'ECF843 0.15 mg/mL BID (Part 1)', 'description': 'ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 5, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'ECF843 Vehicle BID (Part 1)', 'description': 'ECF843 vehicle bis in diem/twice a day (BID) (Part 1)', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 12, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Conjunctival deposit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Corneal erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Eyelids pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Glare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Infected bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Foreign body in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'seriousEvents': [{'term': 'Pelvic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ECF843 0.45 mg/mL TID (Part 1)', 'description': 'ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG001', 'title': 'ECF843 0.15 mg/mL TID (Part 1)', 'description': 'ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG002', 'title': 'ECF843 Vehicle TID (Part 1)', 'description': 'ECF843 vehicle ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG003', 'title': 'ECF843 0.15 mg/mL BID (Part 1)', 'description': 'ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)'}, {'id': 'OG004', 'title': 'ECF843 Vehicle BID (Part 1)', 'description': 'ECF843 vehicle bis in diem/twice a day (BID) (Part 1)'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.0', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-8.1', 'spread': '1.85', 'groupId': 'OG001'}, {'value': '-4.9', 'spread': '1.85', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '1.91', 'groupId': 'OG003'}, {'value': '-6.1', 'spread': '1.84', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.585', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean (LS Mean)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '2.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.107', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean (LS Mean)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-7.01', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.00', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.033', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Squares Mean (LS Mean)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '0.3', 'ciUpperLimit': '8.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.02', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 28 days (Baseline (BL) to end of randomized treatment)', 'description': "The SANDE uses a 100 mm visual analog scale (VAS) and asks the subject to score frequency and severity of their ocular discomfort over the past 24 hours by putting a vertical mark on two separate horizontal scoring lines. The frequency scoring line utilizes the anchors of 'Rarely' to 'All the Time', while the severity scoring line utilizes the anchors of 'Very Mildly' to 'Very Severely uncomfortable'. The SANDE questionnaire was completed through an electronic diary by the subject at the Screening Visit(s) of Part 1, and thereafter every evening before bedtime during the study. The overall SANDE score was calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranged from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. Negative change from baseline indicates improvement.", 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.'}, {'type': 'PRIMARY', 'title': 'Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ECF843 0.45 mg/mL TID (Part 1)', 'description': 'ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG001', 'title': 'ECF843 0.15 mg/mL TID (Part 1)', 'description': 'ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG002', 'title': 'ECF843 Vehicle TID (Part 1)', 'description': 'ECF843 vehicle ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG003', 'title': 'ECF843 0.15 mg/mL BID (Part 1)', 'description': 'ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)'}, {'id': 'OG004', 'title': 'ECF843 Vehicle BID (Part 1)', 'description': 'ECF843 vehicle bis in diem/twice a day (BID) (Part 1)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '0.31', 'groupId': 'OG003'}, {'value': '-1.1', 'spread': '0.30', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.605', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean (LS Mean)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.646', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean (LS Mean)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.847', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Squares Mean (LS Mean)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 28 days (Baseline (BL) to end of randomized treatment)', 'description': 'The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Each of the five regions (central (C), superior (S), inferior (I), temporal (T), and nasal (N)) were graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining. After entry of the scores per region, the total or composite (sum) score for each eye was automatically calculated (maximum score = 20/eye). A (+1) was added to the sum score for any eye with the presence of filaments.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.'}, {'type': 'SECONDARY', 'title': 'Part 1: Change From Baseline in Central Corneal Fluorescein Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ECF843 0.45 mg/mL TID (Part 1)', 'description': 'ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG001', 'title': 'ECF843 0.15 mg/mL TID (Part 1)', 'description': 'ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG002', 'title': 'ECF843 Vehicle TID (Part 1)', 'description': 'ECF843 vehicle ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG003', 'title': 'ECF843 0.15 mg/mL BID (Part 1)', 'description': 'ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)'}, {'id': 'OG004', 'title': 'ECF843 Vehicle BID (Part 1)', 'description': 'ECF843 vehicle bis in diem/twice a day (BID) (Part 1)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.83', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.65', 'groupId': 'OG003'}, {'value': '-0.2', 'spread': '0.74', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 28 days (Baseline (BL) to end of randomized treatment)', 'description': 'The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Central region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.'}, {'type': 'SECONDARY', 'title': 'Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ECF843 0.45 mg/mL TID (Part 1)', 'description': 'ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG001', 'title': 'ECF843 0.15 mg/mL TID (Part 1)', 'description': 'ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG002', 'title': 'ECF843 Vehicle TID (Part 1)', 'description': 'ECF843 vehicle ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG003', 'title': 'ECF843 0.15 mg/mL BID (Part 1)', 'description': 'ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)'}, {'id': 'OG004', 'title': 'ECF843 Vehicle BID (Part 1)', 'description': 'ECF843 vehicle bis in diem/twice a day (BID) (Part 1)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.89', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.98', 'groupId': 'OG003'}, {'value': '-0.6', 'spread': '1.06', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 28 days (Baseline (BL) to end of randomized treatment)', 'description': 'The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Inferior region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'ECF843 0.45 mg/mL TID (Part 1)', 'description': 'ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG001', 'title': 'ECF843 0.15 mg/mL TID (Part 1)', 'description': 'ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG002', 'title': 'ECF843 Vehicle TID (Part 1)', 'description': 'ECF843 vehicle ter in die/three times a day (TID) (Part 1)'}, {'id': 'OG003', 'title': 'ECF843 0.15 mg/mL BID (Part 1)', 'description': 'ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)'}, {'id': 'OG004', 'title': 'ECF843 Vehicle BID (Part 1)', 'description': 'ECF843 vehicle bis in diem/twice a day (BID) (Part 1)'}], 'classes': [{'title': 'Ocular treatment emergent adverse events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Non-ocular treatment emergent adverse events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days (Baseline (BL) to end of randomized treatment)', 'description': 'The number of treatment emergent ocular and non-ocular adverse events was reported categorically: Mild, Moderate, Severe.\n\nTreatment emergent adverse events (TEAEs) are adverse events started after the first administration of randomized study treatment or events present prior to start of the randomized treatment but increased in severity based on preferred term.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set 1'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ECF843 0.45 mg/mL TID (Part 1)', 'description': 'ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'FG001', 'title': 'ECF843 0.15 mg/mL TID (Part 1)', 'description': 'ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'FG002', 'title': 'ECF843 Vehicle TID (Part 1)', 'description': 'ECF843 vehicle ter in die/three times a day (TID) (Part 1)'}, {'id': 'FG003', 'title': 'ECF843 0.15 mg/mL BID (Part 1)', 'description': 'ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)'}, {'id': 'FG004', 'title': 'ECF843 Vehicle BID (Part 1)', 'description': 'ECF843 vehicle bis in diem/twice a day (BID) (Part 1)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All randomized treated subjects were included in Full Analysis Set 1 (FAS1) and Safety Set 1 (SAF1)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '112'}, {'groupId': 'FG002', 'numSubjects': '112'}, {'groupId': 'FG003', 'numSubjects': '109'}, {'groupId': 'FG004', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '108'}, {'groupId': 'FG003', 'numSubjects': '107'}, {'groupId': 'FG004', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Unsatisfactory Therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted in 53 sites in the USA.', 'preAssignmentDetails': 'Approximately 800 subjects were planned to be screened in Part 1 to have approximately 680 subjects randomized into the 56-day treatment period. A total of 970 subjects were screened, of which 558 subjects received randomized treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}, {'value': '558', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'ECF843 0.45 mg/mL TID (Part 1)', 'description': 'ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'BG001', 'title': 'ECF843 0.15 mg/mL TID (Part 1)', 'description': 'ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)'}, {'id': 'BG002', 'title': 'ECF843 Vehicle TID (Part 1)', 'description': 'ECF843 vehicle ter in die/three times a day (TID) (Part 1)'}, {'id': 'BG003', 'title': 'ECF843 0.15 mg/mL BID (Part 1)', 'description': 'ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)'}, {'id': 'BG004', 'title': 'ECF843 Vehicle BID (Part 1)', 'description': 'ECF843 vehicle bis in diem/twice a day (BID) (Part 1)'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'spread': '13.68', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '13.64', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '12.89', 'groupId': 'BG002'}, {'value': '62.9', 'spread': '13.51', 'groupId': 'BG003'}, {'value': '62.7', 'spread': '13.04', 'groupId': 'BG004'}, {'value': '62.0', 'spread': '13.33', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}, {'value': '279', 'groupId': 'BG005'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '279', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}, {'value': '423', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '135', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '83', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '475', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '84', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}, {'value': '99', 'groupId': 'BG004'}, {'value': '451', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Sjogren's Syndrome status", 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}]}, {'title': 'No', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}, {'value': '539', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Status of Sjogren's syndrome was based on history of diagnosis.", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-20', 'size': 902523, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-03T02:59', 'hasProtocol': True}, {'date': '2021-06-09', 'size': 695081, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-05-03T02:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 718}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2020-05-13', 'resultsFirstSubmitDate': '2022-05-03', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-03', 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score', 'timeFrame': 'Up to 28 days (Baseline (BL) to end of randomized treatment)', 'description': "The SANDE uses a 100 mm visual analog scale (VAS) and asks the subject to score frequency and severity of their ocular discomfort over the past 24 hours by putting a vertical mark on two separate horizontal scoring lines. The frequency scoring line utilizes the anchors of 'Rarely' to 'All the Time', while the severity scoring line utilizes the anchors of 'Very Mildly' to 'Very Severely uncomfortable'. The SANDE questionnaire was completed through an electronic diary by the subject at the Screening Visit(s) of Part 1, and thereafter every evening before bedtime during the study. The overall SANDE score was calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranged from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. Negative change from baseline indicates improvement."}, {'measure': 'Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score', 'timeFrame': 'Up to 28 days (Baseline (BL) to end of randomized treatment)', 'description': 'The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Each of the five regions (central (C), superior (S), inferior (I), temporal (T), and nasal (N)) were graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining. After entry of the scores per region, the total or composite (sum) score for each eye was automatically calculated (maximum score = 20/eye). A (+1) was added to the sum score for any eye with the presence of filaments.'}], 'secondaryOutcomes': [{'measure': 'Part 1: Change From Baseline in Central Corneal Fluorescein Staining', 'timeFrame': 'Up to 28 days (Baseline (BL) to end of randomized treatment)', 'description': 'The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Central region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining.'}, {'measure': 'Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining', 'timeFrame': 'Up to 28 days (Baseline (BL) to end of randomized treatment)', 'description': 'The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Inferior region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining.'}, {'measure': 'Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs)', 'timeFrame': 'Up to 28 days (Baseline (BL) to end of randomized treatment)', 'description': 'The number of treatment emergent ocular and non-ocular adverse events was reported categorically: Mild, Moderate, Severe.\n\nTreatment emergent adverse events (TEAEs) are adverse events started after the first administration of randomized study treatment or events present prior to start of the randomized treatment but increased in severity based on preferred term.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry Eye', 'Sjogrens', 'dry eye syndrome (DES)', 'Keratoconjunctivitis sicca (KCS)', 'keratitis', 'Xerophthalmia', "Sjögren's Syndrome", "Sjogren's Syndrome"], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': "The study was planned to be conducted in 2 parts: Part 1 to determine the efficacy and safety of ECF843 vs vehicle, followed by Part 2 with additional exploratory assessments of ECF843 vs Vehicle. Both parts of the study included a double-masked study design, with randomization stratified for subjects with Sjogren's Syndrome.", 'detailedDescription': 'Part 1 of the study was a double-masked, randomized, parallel design in which participants were assigned to one of the following five treatment arms/groups in a ratio of 1:1:1:1:1.\n\n* ECF843 0.45 mg/mL three times daily (TID) or vehicle\n* ECF843 0.15 mg/mL TID or vehicle\n* ECF843 vehicle TID\n* ECF843 0.15 mg/mL twice daily (BID) or vehicle\n* ECF843 vehicle BID The planned duration of double-masked treatment during Part 1 was 56 days. For subjects randomized to ECF843, the maximum drug exposure was up to 28 days. At some point during Part 1, all participants received vehicle.\n\nThe study was terminated after completion of Part 1 and Part 2 of the study was not therefore initiated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent must be obtained before any assessment\n* Adult male or female subjects 18 years of age or older\n* At least 6 months history of dry eye disease in both eyes\n* Must use, or feel the need to use, artificial tears/gels/lubricants on a regular basis\n* Composite corneal fluorescein staining score \\>= 4 (modified National Eye Institute (NEI) scale) in at least one eye\n* Schirmer score \\>= 1 and =\\< 10 mm after 5 minutes in at least one eye\n* Patients with Sjögren's Syndrome must have dry eye\n\nExclusion Criteria:\n\n* Ocular infection in either eye within 30 days prior to Screening\n* Use of artificial tears, gels, lubricants within 4 hours of the Screening Visit\n* Use of contact lenses in either eye within 14 days of Screening\n* Uncontrolled ocular rosacea\n* Clinically significant conjunctivochalasis in either eye\n* Other Corneal conditions affecting the corneal structure\n* Severe ocular conditions such as herpes, graft versus host disease, Stephen's Johnson Syndrome, sarcoidosis\n* Currently active, or history of ocular allergies during the time of year the patient will be participating in the study\n* Patients with current punctal plugs or punctal cauterization or occlusion\n* Chronic medications (both over the counter and prescription) that have not been stable for at least 30 days prior to Screening.\n* Use of Restasis®, Cequa®, or Xiidra® within 30 days prior to Screening\n* Use of ocular, nasal, inhaled, or systemic corticosteroids within 30 days of Screening\n* History of malignancy of any organ system within the past five years\n* Pregnant or nursing women"}, 'identificationModule': {'nctId': 'NCT04391894', 'briefTitle': 'A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-masked, Multicenter Study to Evaluate the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease', 'orgStudyIdInfo': {'id': 'CECF843A2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ECF843 0.45 mg/mL TID or vehicle (Part 1)', 'description': 'ECF843 0.45 mg/mL TID or vehicle (Part 1)', 'interventionNames': ['Drug: ECF843', 'Other: ECF843 vehicle']}, {'type': 'EXPERIMENTAL', 'label': 'ECF843 0.15 mg/mL TID or vehicle (Part 1)', 'description': 'ECF843 0.15 mg/mL TID or vehicle (Part 1)', 'interventionNames': ['Drug: ECF843', 'Other: ECF843 vehicle']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ECF843 vehicle TID (Part 1)', 'description': 'ECF843 vehicle TID (Part 1)', 'interventionNames': ['Other: ECF843 vehicle']}, {'type': 'EXPERIMENTAL', 'label': 'ECF843 0.15 mg/mL BID or vehicle (Part 1)', 'description': 'ECF843 0.15 mg/mL BID or vehicle (Part 1)', 'interventionNames': ['Drug: ECF843', 'Other: ECF843 vehicle']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ECF843 vehicle BID (Part 1)', 'description': 'ECF843 vehicle BID (Part 1)', 'interventionNames': ['Other: ECF843 vehicle']}], 'interventions': [{'name': 'ECF843', 'type': 'DRUG', 'description': 'Topical ocular eye drop', 'armGroupLabels': ['ECF843 0.15 mg/mL BID or vehicle (Part 1)', 'ECF843 0.15 mg/mL TID or vehicle (Part 1)', 'ECF843 0.45 mg/mL TID or vehicle (Part 1)']}, {'name': 'ECF843 vehicle', 'type': 'OTHER', 'description': 'Topical ocular eye drop', 'armGroupLabels': ['ECF843 0.15 mg/mL BID or vehicle (Part 1)', 'ECF843 0.15 mg/mL TID or vehicle (Part 1)', 'ECF843 0.45 mg/mL TID or vehicle (Part 1)', 'ECF843 vehicle BID (Part 1)', 'ECF843 vehicle TID (Part 1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Eye Center', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85202', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Carrot Eye Center', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Eye Care and Dry Eye Ctr', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91702', 'city': 'Azusa', 'state': 'California', 'country': 'United States', 'facility': 'Milton Hom OD', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}, {'zip': '92843', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Opthamology Med Grp', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '91203', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Dr Kent Small', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '91205', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Global Research Management', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'United Medical Research Institute', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Harvard Eye Associates', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'North Valley Eye Medical Group', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'The Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'facility': 'North Bay Eye Associates Inc', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'facility': 'Martel Eye Medical Group', 'geoPoint': {'lat': 38.58907, 'lon': -121.30273}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Sierra Clin Trials Rsch Org', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Vision Institute', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33064', 'city': 'Deerfield Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Research LLC', 'geoPoint': {'lat': 26.31841, 'lon': -80.09977}}, {'zip': '33309', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Pinnacle Research Institute', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Associates Of Fort Myers', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33773', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Lee Shettle Eye & Hearing', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '32757', 'city': 'Mt. Dora', 'state': 'Florida', 'country': 'United States', 'facility': 'Mid Florida Eye Center Pa', 'geoPoint': {'lat': 28.80249, 'lon': -81.64452}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kannarr Eye Care', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The Eye Care Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '64133', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Silverstein Eye Centers', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64154', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Moyes Eye Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Tekwani Vision Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63090', 'city': 'Washington', 'state': 'Missouri', 'country': 'United States', 'facility': 'Comprehensive Eye Care Limited', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'NV Eye Surgery', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '89123', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'AdvanceMed Clinical Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07079', 'city': 'South Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Northern New Jersey Eye Institut PA', 'geoPoint': {'lat': 40.74899, 'lon': -74.26126}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United 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'lon': -75.85946}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision Hospital', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37411', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Chattanooga Eye Institute', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37803', 'city': 'Maryville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University Eye Specialists', 'geoPoint': {'lat': 35.75647, 'lon': -83.97046}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care PA', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Toyos Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37167', 'city': 'Smyrna', 'state': 'Tennessee', 'country': 'United States', 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