Viewing Study NCT05467293


Ignite Creation Date: 2025-12-25 @ 12:57 AM
Ignite Modification Date: 2025-12-25 @ 11:11 PM
Study NCT ID: NCT05467293
Status: COMPLETED
Last Update Posted: 2024-07-30
First Post: 2022-06-28
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1)
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-10', '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': 'wsyu@yuyu.co.kr', 'phone': '+82 2 6972 9062', 'title': 'Robert Wonsang Yu', 'organization': 'Yuyu Pharma, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '13 Weeks', 'eventGroups': [{'id': 'EG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 28, 'seriousNumAtRisk': 86, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 34, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 42, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Instillation Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acquired hypertrophy of the retinal pigment epithelium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyelid myokymia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Greater trochanteric pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intravertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Attention deficit hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-traumatic stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic, and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Keloid scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 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Schirmer's test can be interpreted as follows: 0 to 5 mm: extremely dry eyes; 5 to 10 mm: moderately dry eyes; 10 to 15 mm: possible dry eyes; Longer than 15 mm: normal tear function.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Tear Film Break-up Time (TFBUT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.598', 'spread': '0.8443', 'groupId': 'OG000'}, {'value': '2.540', 'spread': '0.9201', 'groupId': 'OG001'}, {'value': '2.441', 'spread': '0.8812', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Ocular Surface Disease Index (OSDI): Subtotal 1-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '37.44', 'spread': '19.804', 'groupId': 'OG000'}, {'value': '37.71', 'spread': '21.555', 'groupId': 'OG001'}, {'value': '37.50', 'spread': '17.485', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'Ocular Surface Disease Index Scale 0-100 (higher is worse)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Ocular Surface Disease Index (OSDI): Subtotal 6-9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '39.29', 'spread': '24.653', 'groupId': 'OG000'}, {'value': '40.34', 'spread': '27.580', 'groupId': 'OG001'}, {'value': '35.75', 'spread': '22.152', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'Ocular Surface Disease Index Scale 0-100 (higher is worse)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Ocular Surface Disease Index (OSDI): Subtotal 10-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '55.86', 'spread': '27.538', 'groupId': 'OG000'}, {'value': '49.26', 'spread': '27.346', 'groupId': 'OG001'}, {'value': '55.53', 'spread': '26.114', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'Ocular Surface Disease Index Scale 0-100 (higher is worse)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Ocular Surface Disease Index (OSDI): Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '42.49', 'spread': '19.426', 'groupId': 'OG000'}, {'value': '41.46', 'spread': '20.031', 'groupId': 'OG001'}, {'value': '41.42', 'spread': '17.098', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'Ocular Surface Disease Index Scale 0-100 (higher is worse)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Burning/Stinging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'spread': '25.56', 'groupId': 'OG000'}, {'value': '37.9', 'spread': '28.33', 'groupId': 'OG001'}, {'value': '43.3', 'spread': '26.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '25.05', 'groupId': 'OG000'}, {'value': '44.2', 'spread': '28.09', 'groupId': 'OG001'}, {'value': '40.9', 'spread': '25.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Foreign Body Sensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '27.62', 'groupId': 'OG000'}, {'value': '40.2', 'spread': '28.63', 'groupId': 'OG001'}, {'value': '40.6', 'spread': '28.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 Weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Blurred Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'spread': '27.90', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '28.89', 'groupId': 'OG001'}, {'value': '41.5', 'spread': '26.62', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 Weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Eye Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '24.50', 'groupId': 'OG000'}, {'value': '65.3', 'spread': '23.51', 'groupId': 'OG001'}, {'value': '60.4', 'spread': '23.42', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 Weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Photophobia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '44.9', 'spread': '27.70', 'groupId': 'OG000'}, {'value': '47.1', 'spread': '29.82', 'groupId': 'OG001'}, {'value': '44.0', 'spread': '29.57', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 Weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Pain in Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '27.26', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '25.64', 'groupId': 'OG001'}, {'value': '33.6', 'spread': '28.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 Weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Treatment Compliance Using a Daily Compliance Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '114.90', 'spread': '134.816', 'groupId': 'OG000'}, {'value': '100.13', 'spread': '4.525', 'groupId': 'OG001'}, {'value': '100.83', 'spread': '8.480', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': "Self-Administrating with use of Daily Compliance Diary. Subject daily diaries were collected at Visits 1 through 6, and the subject's used and unused study drug ampules were collected at Visit 3 through 6. Dosing compliance was based on the used and unused ampule count. If the subject was less than 80% or more than 125% compliant with dosing based on the expected number of used ampules, then the subject was deemed noncompliant and a dosing deviation was recorded.\n\nDosing compliance (% compliance) was assessed by calculating the number of actual doses received and comparing that to the number of expected doses as follows:\n\nCompliance (%) = Number of Actual Doses Received / Number of Expected Doses x 100%\n\nThe number of expected doses that will be used for calculating compliance was calculated as:\n\n2 x \\[(Date of Last Dose - Date of First Dose) + 1\\]", 'unitOfMeasure': 'percentage of compliance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Drop Comfort - Positive Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '84.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '84.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '13 weeks', 'description': 'A drop comfort evaluation will be performed immediately upon administration of study drug and then at 1, 2, and 3 minutes following initial dosing using the Ora Calibra Drop Comfort Scale', 'unitOfMeasure': 'percentage of comfort', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 weeks', 'description': 'Visual Acuity was assessed using an ETDRS chart', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Slit-lamp Evaluation Biomicroscopy - Subjects That Had a Shift From Normal/Abnormal NCS to Abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 weeks', 'description': 'Slit lamp biomicroscopic observations will be graded as Normal or Abnormal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Event Query - TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 weeks', 'description': 'Each subject will be queried regarding adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Event Query - Ocular TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 Weeks', 'description': 'Each subject will be queried regarding adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Event Query - Non Ocular TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 Weeks', 'description': 'Each subject will be queried regarding adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 Weeks', 'description': 'Each subject will be queried regarding adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Event Query - TEAEs Suspected to be Related to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'title': 'Definitely related to study drug', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Probably related to study drug', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Possibly related to study drug', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'No TEAE Reported', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 Weeks', 'description': 'Each subject will be queried regarding adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Event Query - SEA Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 Weeks', 'description': 'Each subject will be queried regarding adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dilated Fundoscopy: Shift From Normal/Abnormal NCS to Abnormal CS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 weeks', 'description': 'using indirect ophthalmoscopy. The Investigator will make observations of the vitreous, retina, macula, choroid and optic nerve.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG001', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 weeks', 'description': 'A single measurement is made', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': 'Participants enrolled in 0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution group'}, {'id': 'FG001', 'title': '1% YP-P10 Ophthalmic Solution', 'description': 'Participants enrolled in 1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution group'}, {'id': 'FG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'Participants enrolled in YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle) group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '257', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '0.3% YP-P10 Ophthalmic Solution', 'description': '0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'BG001', 'title': '1% YP-P10 Ophthalmic Solution', 'description': '1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution'}, {'id': 'BG002', 'title': 'YP-P10 Placebo Ophthalmic Solution (Vehicle)', 'description': 'YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': 'NA', 'comment': 'Participants must be over 18 years old to partake in study', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Participants must be over 18 years old to partake in study', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Participants must be over 18 years old to partake in study', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '257', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Iris Color (OD)', 'classes': [{'categories': [{'title': 'Black', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Blue', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Brown', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}]}, {'title': 'Hazel', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Green', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Gray', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Iris Color (OS)', 'classes': [{'categories': [{'title': 'Black', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Blue', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Brown', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}]}, {'title': 'Hazel', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Green', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Gray', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-03', 'size': 912321, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-27T09:02', 'hasProtocol': True}, {'date': '2023-03-09', 'size': 4194001, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-27T09:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Before the initiation of study run-in at Visit 1, each subject who provides written informed consent will be assigned a screening number. All screening numbers will be assigned in strict numerical sequence at a site and no numbers will skipped or omitted. Each subject who meets all the inclusion and none of the exclusion criteria at Visit 1 and Visit 2 will be assigned a randomization number at the end of Visit 2. The Interactive Web Response System (IWRS) will be used to assign all randomization numbers.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicenter, randomized, double-masked, placebo-controlled clinical study. Subjects will be randomized to one of the following treatment arms at Visit 2 (Day 1):\n\n* 0.3% YP-P10 Ophthalmic Solution: 1 drop BID in each eye (N = \\~80)\n* 1% YP-P10 Ophthalmic Solution: 1 drop BID in each eye (N = \\~80)\n* YP-P10 Placebo Ophthalmic Solution (vehicle): 1 drop BID in each eye (N = \\~80)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2022-06-28', 'resultsFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2022-07-15', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-23', 'studyFirstPostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Corneal Fluorescein Staining', 'timeFrame': 'Day 85', 'description': 'Modified National Eye Institute Scale; 0-20: Higher is Worse'}, {'measure': 'Ocular Discomfort Score', 'timeFrame': 'Day 85', 'description': 'Visual Analogue Scale; 0-100: Higher is Worse'}], 'secondaryOutcomes': [{'measure': 'Fluorescein Staining: Inferior', 'timeFrame': '13 weeks', 'description': 'Modified National Eye Institute Scale; 0-4: Higher is Worse'}, {'measure': 'Fluorescein Staining: Superior', 'timeFrame': '13 weeks', 'description': 'Modified National Eye Institute Scale; 0-4: Higher is Worse'}, {'measure': 'Fluorescein Staining: Central', 'timeFrame': '13 weeks', 'description': 'Modified National Eye Institute Scale; 0-4: Higher is Worse'}, {'measure': 'Fluorescein Staining: Temporal', 'timeFrame': '13 weeks', 'description': 'Modified National Eye Institute Scale; 0-4: Higher is Worse'}, {'measure': 'Fluorescein Staining: Nasal', 'timeFrame': '13 weeks', 'description': 'Modified National Eye Institute Scale; 0-4: Higher is Worse'}, {'measure': 'Lissamine Green Staining: Conjunctival Sum', 'timeFrame': '13 weeks', 'description': 'Modified National Eye Institute Scale; 0-24: Higher is Worse'}, {'measure': 'Lissamine Green Staining: Inferior Temporal', 'timeFrame': '13 weeks', 'description': 'Modified National Eye Institute Scale; 0-4: Higher is Worse'}, {'measure': 'Lissamine Green Staining: Superior Temporal', 'timeFrame': '13 weeks', 'description': 'Modified National Eye Institute Scale; 0-4 Higher is Worse'}, {'measure': 'Lissamine Green Staining: Temporal', 'timeFrame': '13 weeks', 'description': 'Modified National Eye Institute Scale; 0-4 Higher is Worse'}, {'measure': 'Lissamine Green Staining: Inferior Nasal', 'timeFrame': '13 weeks', 'description': 'Modified National Eye Institute Scale; 0-4 Higher is Worse'}, {'measure': 'Lissamine Green Staining: Superior Nasal', 'timeFrame': '13 weeks', 'description': 'Modified National Eye Institute Scale; 0-4 Higher is Worse'}, {'measure': 'Lissamine Green Staining: Nasal', 'timeFrame': '13 weeks', 'description': 'Modified National Eye Institute Scale; 0-4 Higher is Worse'}, {'measure': 'Conjunctival Redness', 'timeFrame': '13 weeks', 'description': 'Ora Calibra Scale; 0-4 Higher is Worse'}, {'measure': "Unanesthetized Schirmer's Test", 'timeFrame': '13 weeks', 'description': "score on a scale of ≤ 10 mm/5 minutes and ≥ 1 mm/5 minutes in at least one eye. Schirmer's test can be interpreted as follows: 0 to 5 mm: extremely dry eyes; 5 to 10 mm: moderately dry eyes; 10 to 15 mm: possible dry eyes; Longer than 15 mm: normal tear function."}, {'measure': 'Tear Film Break-up Time (TFBUT)', 'timeFrame': '13 weeks'}, {'measure': 'Ocular Surface Disease Index (OSDI): Subtotal 1-5', 'timeFrame': '13 weeks', 'description': 'Ocular Surface Disease Index Scale 0-100 (higher is worse)'}, {'measure': 'Ocular Surface Disease Index (OSDI): Subtotal 6-9', 'timeFrame': '13 weeks', 'description': 'Ocular Surface Disease Index Scale 0-100 (higher is worse)'}, {'measure': 'Ocular Surface Disease Index (OSDI): Subtotal 10-12', 'timeFrame': '13 weeks', 'description': 'Ocular Surface Disease Index Scale 0-100 (higher is worse)'}, {'measure': 'Ocular Surface Disease Index (OSDI): Total', 'timeFrame': '13 weeks', 'description': 'Ocular Surface Disease Index Scale 0-100 (higher is worse)'}, {'measure': 'Burning/Stinging', 'timeFrame': '13 weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse'}, {'measure': 'Itching', 'timeFrame': '13 weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse'}, {'measure': 'Foreign Body Sensation', 'timeFrame': '13 Weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse'}, {'measure': 'Blurred Vision', 'timeFrame': '13 Weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse'}, {'measure': 'Eye Dryness', 'timeFrame': '13 Weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse'}, {'measure': 'Photophobia', 'timeFrame': '13 Weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse'}, {'measure': 'Pain in Eyes', 'timeFrame': '13 Weeks', 'description': 'Visual Analog Scale; 0-100: Higher is Worse'}, {'measure': 'Treatment Compliance Using a Daily Compliance Diary', 'timeFrame': '13 weeks', 'description': "Self-Administrating with use of Daily Compliance Diary. Subject daily diaries were collected at Visits 1 through 6, and the subject's used and unused study drug ampules were collected at Visit 3 through 6. Dosing compliance was based on the used and unused ampule count. If the subject was less than 80% or more than 125% compliant with dosing based on the expected number of used ampules, then the subject was deemed noncompliant and a dosing deviation was recorded.\n\nDosing compliance (% compliance) was assessed by calculating the number of actual doses received and comparing that to the number of expected doses as follows:\n\nCompliance (%) = Number of Actual Doses Received / Number of Expected Doses x 100%\n\nThe number of expected doses that will be used for calculating compliance was calculated as:\n\n2 x \\[(Date of Last Dose - Date of First Dose) + 1\\]"}, {'measure': 'Drop Comfort - Positive Response', 'timeFrame': '13 weeks', 'description': 'A drop comfort evaluation will be performed immediately upon administration of study drug and then at 1, 2, and 3 minutes following initial dosing using the Ora Calibra Drop Comfort Scale'}, {'measure': 'Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR', 'timeFrame': '13 weeks', 'description': 'Visual Acuity was assessed using an ETDRS chart'}, {'measure': 'Slit-lamp Evaluation Biomicroscopy - Subjects That Had a Shift From Normal/Abnormal NCS to Abnormal CS', 'timeFrame': '13 weeks', 'description': 'Slit lamp biomicroscopic observations will be graded as Normal or Abnormal'}, {'measure': 'Adverse Event Query - TEAEs', 'timeFrame': '13 weeks', 'description': 'Each subject will be queried regarding adverse events'}, {'measure': 'Adverse Event Query - Ocular TEAEs', 'timeFrame': '13 Weeks', 'description': 'Each subject will be queried regarding adverse events'}, {'measure': 'Adverse Event Query - Non Ocular TEAEs', 'timeFrame': '13 Weeks', 'description': 'Each subject will be queried regarding adverse events'}, {'measure': 'Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation', 'timeFrame': '13 Weeks', 'description': 'Each subject will be queried regarding adverse events'}, {'measure': 'Adverse Event Query - TEAEs Suspected to be Related to Study Drug', 'timeFrame': '13 Weeks', 'description': 'Each subject will be queried regarding adverse events'}, {'measure': 'Adverse Event Query - SEA Reported', 'timeFrame': '13 Weeks', 'description': 'Each subject will be queried regarding adverse events'}, {'measure': 'Dilated Fundoscopy: Shift From Normal/Abnormal NCS to Abnormal CS', 'timeFrame': '13 weeks', 'description': 'using indirect ophthalmoscopy. The Investigator will make observations of the vitreous, retina, macula, choroid and optic nerve.'}, {'measure': 'Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges', 'timeFrame': '13 weeks', 'description': 'A single measurement is made'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the safety and efficacy of YP-P10 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.', 'detailedDescription': 'The clinical hypotheses for this study is that 0.3% YP-P10 Ophthalmic Solution twice daily (BID) and 1.0% YP-P10 Ophthalmic Solution BID are superior to YP-P10 Placebo Ophthalmic Solution (vehicle) for the primary endpoints of signs and symptoms of dry eye, as follows:\n\n* Sign: Total corneal fluorescein staining score of the study eye using the modified NEI grading scale, measured by mean change from baseline (Visit 2, Pre- Controlled Adverse Environment \\[CAE®\\]) to Visit 6\n* Symptom: Ocular discomfort score of both eyes using the Visual Analog Scale (VAS) Ocular Discomfort Scale, measured by mean change from baseline (Visit 2, Pre-CAE®) to Visit 6'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n• Individuals eligible to participate in this study must meet all of the following criteria: 0. Be at least 18 years of age;\n\n1. Provide written informed consent;\n2. Be willing and able to comply with all study procedures;\n3. Have a patient-reported history of dry eye for at least 6 months prior to Visit 1;\n4. Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;\n5. Have a best corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1;\n6. Have a score of ≥ 2 for both eyes according to the Ora Calibra® Ocular Discomfort \\& 4- Symptom Questionnaire in at least one of the dry eye symptoms at Visits 1 and 2;\n7. Have an unanesthetized Schirmer's Test score of ≤ 10 mm/5 minutes and ≥ 1 mm/5 minutes in at least one eye at Visits 1 and 2;\n8. Have a corneal fluorescein staining score of ≥ 2 according to the Ora Calibra® Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining in at least one region in one eye at Visits 1 and 2 and a central score ≥ 1 in the same eye;\n9. Have a conjunctival redness score ≥ 1 according to the Ora Calibra® Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2 pre-CAE®;\n10. Demonstrate in the same eye(s) a response to the CAE® at Visits 1 and 2 as defined by:\n\n * Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE® exposure; a. Reporting an Ocular Discomfort score ≥ 3 at 2 or more consecutive time points in at least one eye during CAE® exposure (if a subject has an Ocular Discomfort rating of 3 at time = 0 for an eye, s/he must report an Ocular Discomfort rating of 4 for two consecutive measurements for that eye). Note: a subject cannot have an Ocular Discomfort score of 4 at time = 0);\n11. Have at least one eye, the same eye, satisfy all criteria for 8, 9, 10 and 11 above;\n12. A negative urine pregnancy test if female of childbearing potential (those who are not surgically sterilized \\[bilateral tubal ligation, hysterectomy or bilateral oophorectomy\\] or post-menopausal \\[12 months after last menses\\]) and must use adequate birth control through the study period. For non-sexually active females, abstinence may be regarded as an adequate method of birth control.)\n\nExclusion Criteria:\n\n• Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study: 0. 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\n1. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;\n2. Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;\n3. Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;\n4. Have used Restasis®, Xiidra®, or Cequa®, Eysuvis™ and Tyrvaya™ within 60 days of Visit 1;\n5. Have had any ocular and/or lid surgeries in the past 6 months or have any planned ocular and/or lid surgeries over the study period;\n6. Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;\n7. Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter 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); the respective wash- out periods are required for the following medications:\n\n * Antihistamines (including ocular): 72 hours prior to Visit 1\n\n 1. Oral aspirin or aspirin-containing products allowed if dose has been stable over past 30 days prior to Visit 1 and no change in dose is anticipated during the study period\n 2. Corticosteroids or mast cell stabilizers (including ocular): 14 days prior to Visit 1\n 3. Any medication (oral or topical) known to cause ocular drying that has not been administered as a stable dose for at least 30 days prior to Visit 1 and during the study\n 4. All other topical ophthalmic preparations (including artificial tear substitutes) other than the study drops: 72 hours prior to Visit 1\n8. Have an uncontrolled systemic disease;\n9. Be a woman who is pregnant, nursing, or planning a pregnancy;\n10. Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 6 (or early termination visit) if of childbearing potential. Non- childbearing potential is defined as a woman who is permanently sterilized (e.g., has had a hysterectomy or tubal ligation), or is post- menopausal (without menses for 12 consecutive months);\n11. Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study;\n12. Have a known allergy and/or sensitivity to the test article or its components;\n13. Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;\n14. Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;\n15. Be unable or unwilling to follow instructions, including participation in all study assessments and visits."}, 'identificationModule': {'nctId': 'NCT05467293', 'briefTitle': 'Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuyu Pharma, Inc.'}, 'officialTitle': 'A Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1)', 'orgStudyIdInfo': {'id': 'YPP10-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '0.3% YP-P10 Ophthalmic Solution', 'interventionNames': ['Drug: 0.3% YP-P10 Ophthalmic Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1% YP-P10 Ophthalmic Solution', 'interventionNames': ['Drug: 1% YP-P10 Ophthalmic Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'YP-P10 Placebo Ophthalmic Solution (vehicle)', 'interventionNames': ['Drug: YP-P10 Placebo Ophthalmic Solution (vehicle)']}], 'interventions': [{'name': '0.3% YP-P10 Ophthalmic Solution', 'type': 'DRUG', 'description': 'Drug: YP-P10 Ophthalmic Solution', 'armGroupLabels': ['0.3% YP-P10 Ophthalmic Solution']}, {'name': '1% YP-P10 Ophthalmic Solution', 'type': 'DRUG', 'description': 'Drug: YP-P10 Ophthalmic Solution', 'armGroupLabels': ['1% YP-P10 Ophthalmic Solution']}, {'name': 'YP-P10 Placebo Ophthalmic Solution (vehicle)', 'type': 'DRUG', 'description': 'Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)', 'armGroupLabels': ['YP-P10 Placebo Ophthalmic Solution (vehicle)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cornea Consultants of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Aesthetic Eye Care Institute', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Vision Institute', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '27502', 'city': 'Apex', 'state': 'North Carolina', 'country': 'United States', 'facility': 'NC Eye Associates', 'geoPoint': {'lat': 35.73265, 'lon': -78.85029}}, {'zip': '27529', 'city': 'Garner', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Oculus Research', 'geoPoint': {'lat': 35.71126, 'lon': -78.61417}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuyu Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}