Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-10 @ 1:36 AM
Study NCT ID:
NCT03216902
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2017-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077338', 'term': 'Latanoprost'}], 'ancestors': [{'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@santen.com', 'phone': '+1 415 268 9199', 'title': 'R&D Quality Manager', 'organization': 'Santen Inc'}, 'certainAgreement': {'otherDetails': "If Institution/Principal Investigator wishes to publish findings, they must submit draft to Santen at least 30 days prior, deleting Confidential Information if requested. Santen must be allowed up to ninety (90) days to determine if patent application is to be filed. Santen has right to first publication of Multi-Center Research results, but if publication doesn't occur within 12 months after completion, Institution/Principal Investigator may individually publish site's results.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Reporting time frame is from Inform Consent to end of the study at Month3.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo P1', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 2, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo P2', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution treatment arm dosed by high dose of DE-126 dosed once daily from w6 to month3.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 10, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '0.005% Latanoprost', 'description': '0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 18, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Ultra-low Dose DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 13, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Low Dose DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 12, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Medium Dose DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 10, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'High Dose of DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 12, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'High Dose of DE-126 Total', 'description': 'Summarizes columns High dose of DE-126 and Placebo P2', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 22, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'DE-126 Total', 'description': 'Total summarizes columns Ultra Low Dose, Low Dose, Medium Dose, High Dose and Placebo P2.', 'otherNumAtRisk': 195, 'deathsNumAtRisk': 195, 'otherNumAffected': 57, 'seriousNumAtRisk': 195, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 33, 'numAffected': 28}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Growth Of Eyelashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Instillation Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alveolar Osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic Enzyme Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertonic Bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 195, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure in the Study Eye at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Vehicle of DE-126) Followed by High Dose of DE-126', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks'}, {'id': 'OG001', 'title': '0.005% Latanoprost', 'description': '0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Ultra-low Dose 0.0005% DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Low Dose 0.001% DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Medium Dose 0.002% DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG005', 'title': 'High Dose 0.003% DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}], 'classes': [{'title': '9:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18.8', 'spread': '4.11', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '3.73', 'groupId': 'OG001'}, {'value': '19.7', 'spread': '3.27', 'groupId': 'OG002'}, {'value': '19.2', 'spread': '3.37', 'groupId': 'OG003'}, {'value': '17.6', 'spread': '3.13', 'groupId': 'OG004'}, {'value': '19.3', 'spread': '2.92', 'groupId': 'OG005'}]}]}, {'title': '13:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '17.6', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '3.01', 'groupId': 'OG001'}, {'value': '18.5', 'spread': '2.98', 'groupId': 'OG002'}, {'value': '18.1', 'spread': '2.99', 'groupId': 'OG003'}, {'value': '17.4', 'spread': '2.39', 'groupId': 'OG004'}, {'value': '18.7', 'spread': '3.17', 'groupId': 'OG005'}]}]}, {'title': '17:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '17.8', 'spread': '2.87', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '3.10', 'groupId': 'OG001'}, {'value': '18.3', 'spread': '2.55', 'groupId': 'OG002'}, {'value': '17.8', 'spread': '2.93', 'groupId': 'OG003'}, {'value': '16.7', 'spread': '2.74', 'groupId': 'OG004'}, {'value': '17.9', 'spread': '2.82', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9:00, 13:00 and 17:00 at Month 3', 'description': 'Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is reduced due to missing data.'}, {'type': 'SECONDARY', 'title': 'Intraocular Pressure in the Study Eye at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Vehicle of DE-126) Followed by High Dose of DE-126', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks'}, {'id': 'OG001', 'title': 'Ultra-low Dose 0.0005% DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Low Dose 0.001% DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Medium Dose 0.002% DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG004', 'title': 'High Dose 0.003% DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}], 'classes': [{'title': '9:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '23.2', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '18.5', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '18.7', 'spread': '0.45', 'groupId': 'OG003'}, {'value': '18.7', 'spread': '0.45', 'groupId': 'OG004'}]}]}, {'title': '13:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '22.2', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '17.9', 'spread': '0.42', 'groupId': 'OG002'}, {'value': '17.3', 'spread': '0.42', 'groupId': 'OG003'}, {'value': '17.5', 'spread': '0.41', 'groupId': 'OG004'}]}]}, {'title': '17:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '21.6', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '17.9', 'spread': '0.43', 'groupId': 'OG002'}, {'value': '16.6', 'spread': '0.42', 'groupId': 'OG003'}, {'value': '17.4', 'spread': '0.42', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value is adjusted for multiple comparisons using Hochberg step-up procedure.', 'groupDescription': 'This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P value is adjusted for multiple comparisons using Hochberg step-up procedure.', 'groupDescription': 'This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P value is adjusted for multiple comparisons using Hochberg step-up procedure.', 'groupDescription': 'This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'pValueComment': 'P value is adjusted for multiple comparisons using Hochberg step-up procedure.', 'groupDescription': 'This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '9:00, 13:00 and 17:00 at Week 6', 'description': 'Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is reduced due to missing data. This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Intraocular Pressure in the Study Eye at Week 1 and Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Vehicle of DE-126) Followed by High Dose of DE-126', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks'}, {'id': 'OG001', 'title': '0.005% Latanoprost', 'description': '0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Ultra-low Dose 0.0005% DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Low Dose 0.001% DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Medium Dose 0.002% DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG005', 'title': 'High Dose 0.003% DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}], 'classes': [{'title': 'Week1 9:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.8', 'spread': '3.99', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '2.67', 'groupId': 'OG001'}, {'value': '19.4', 'spread': '3.32', 'groupId': 'OG002'}, {'value': '18.9', 'spread': '2.82', 'groupId': 'OG003'}, {'value': '18.1', 'spread': '2.99', 'groupId': 'OG004'}, {'value': '18.0', 'spread': '2.66', 'groupId': 'OG005'}]}]}, {'title': 'Week1 13:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.8', 'spread': '3.66', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '18.7', 'spread': '3.28', 'groupId': 'OG002'}, {'value': '18.6', 'spread': '3.29', 'groupId': 'OG003'}, {'value': '17.1', 'spread': '2.65', 'groupId': 'OG004'}, {'value': '17.6', 'spread': '3.08', 'groupId': 'OG005'}]}]}, {'title': 'Week1 17:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '21.6', 'spread': '3.94', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '2.43', 'groupId': 'OG001'}, {'value': '18.1', 'spread': '2.94', 'groupId': 'OG002'}, {'value': '18.5', 'spread': '3.23', 'groupId': 'OG003'}, {'value': '16.9', 'spread': '2.96', 'groupId': 'OG004'}, {'value': '17.2', 'spread': '2.53', 'groupId': 'OG005'}]}]}, {'title': 'Week 2 9:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.7', 'spread': '3.70', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '3.33', 'groupId': 'OG001'}, {'value': '19.4', 'spread': '3.62', 'groupId': 'OG002'}, {'value': '18.7', 'spread': '2.73', 'groupId': 'OG003'}, {'value': '17.9', 'spread': '3.11', 'groupId': 'OG004'}, {'value': '18.3', 'spread': '3.13', 'groupId': 'OG005'}]}]}, {'title': 'Week 2 13:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.0', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '2.45', 'groupId': 'OG001'}, {'value': '18.2', 'spread': '2.93', 'groupId': 'OG002'}, {'value': '18.1', 'spread': '2.77', 'groupId': 'OG003'}, {'value': '17.2', 'spread': '2.57', 'groupId': 'OG004'}, {'value': '17.6', 'spread': '2.80', 'groupId': 'OG005'}]}]}, {'title': 'Week2 17:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '21.9', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '2.49', 'groupId': 'OG001'}, {'value': '18.2', 'spread': '2.94', 'groupId': 'OG002'}, {'value': '17.8', 'spread': '2.33', 'groupId': 'OG003'}, {'value': '16.7', 'spread': '2.89', 'groupId': 'OG004'}, {'value': '17.3', 'spread': '2.59', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9:00, 13:00 and 17:00 at Week 1 and Week 2', 'description': 'Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is reduced due to missing data.'}, {'type': 'SECONDARY', 'title': 'Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Vehicle of DE-126) Followed by High Dose of DE-126', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks'}, {'id': 'OG001', 'title': '0.005% Latanoprost', 'description': '0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Ultra-low Dose 0.0005% DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Low Dose 0.001% DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Medium Dose 0.002% DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG005', 'title': 'High Dose 0.003% DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.4', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '18.8', 'spread': '2.95', 'groupId': 'OG002'}, {'value': '18.7', 'spread': '2.88', 'groupId': 'OG003'}, {'value': '17.4', 'spread': '2.64', 'groupId': 'OG004'}, {'value': '17.6', 'spread': '2.59', 'groupId': 'OG005'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.2', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '2.51', 'groupId': 'OG001'}, {'value': '18.6', 'spread': '2.92', 'groupId': 'OG002'}, {'value': '18.2', 'spread': '2.37', 'groupId': 'OG003'}, {'value': '17.3', 'spread': '2.58', 'groupId': 'OG004'}, {'value': '17.7', 'spread': '2.52', 'groupId': 'OG005'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '21.7', 'spread': '2.90', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '2.80', 'groupId': 'OG001'}, {'value': '18.4', 'spread': '2.40', 'groupId': 'OG002'}, {'value': '18.1', 'spread': '2.50', 'groupId': 'OG003'}, {'value': '17.5', 'spread': '2.69', 'groupId': 'OG004'}, {'value': '17.8', 'spread': '2.69', 'groupId': 'OG005'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18.1', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '2.98', 'groupId': 'OG001'}, {'value': '18.8', 'spread': '2.66', 'groupId': 'OG002'}, {'value': '18.4', 'spread': '2.94', 'groupId': 'OG003'}, {'value': '17.2', 'spread': '2.47', 'groupId': 'OG004'}, {'value': '18.6', 'spread': '2.71', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 6 and Month 3.', 'description': 'Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is reduced due to missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Vehicle of DE-126) Followed by High Dose of DE-126', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks'}, {'id': 'OG001', 'title': '0.005% Latanoprost', 'description': '0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Ultra-low Dose 0.0005% DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG003', 'title': '0.001% Low Dose DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Medium Dose 0.002% DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG005', 'title': 'High Dose 0.003% DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '2.98', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '2.41', 'groupId': 'OG002'}, {'value': '-5.6', 'spread': '2.84', 'groupId': 'OG003'}, {'value': '-6.7', 'spread': '3.19', 'groupId': 'OG004'}, {'value': '-6.6', 'spread': '2.92', 'groupId': 'OG005'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '3.13', 'groupId': 'OG001'}, {'value': '-5.8', 'spread': '3.02', 'groupId': 'OG002'}, {'value': '-6.0', 'spread': '2.35', 'groupId': 'OG003'}, {'value': '-6.9', 'spread': '2.87', 'groupId': 'OG004'}, {'value': '-6.5', 'spread': '2.94', 'groupId': 'OG005'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '3.09', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '2.73', 'groupId': 'OG002'}, {'value': '-6.1', 'spread': '2.59', 'groupId': 'OG003'}, {'value': '-6.6', 'spread': '3.08', 'groupId': 'OG004'}, {'value': '-6.4', 'spread': '2.68', 'groupId': 'OG005'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '3.24', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '2.11', 'groupId': 'OG002'}, {'value': '-5.9', 'spread': '2.71', 'groupId': 'OG003'}, {'value': '-6.9', 'spread': '2.96', 'groupId': 'OG004'}, {'value': '-5.5', 'spread': '2.67', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 6 and Month 3.', 'description': 'Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is reduced due to missing data.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Vehicle of DE-126) Followed by High Dose of DE-126', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks'}, {'id': 'OG001', 'title': '0.005% Latanoprost', 'description': '0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Ultra-low Dose 0.0005% DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Low Dose 0.001% DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Medium Dose 0.002% DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG005', 'title': 'High Dose 0.003% DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-8.6', 'spread': '8.15', 'groupId': 'OG000'}, {'value': '-27.3', 'spread': '10.60', 'groupId': 'OG001'}, {'value': '-22.8', 'spread': '9.59', 'groupId': 'OG002'}, {'value': '-22.9', 'spread': '10.78', 'groupId': 'OG003'}, {'value': '-27.4', 'spread': '11.48', 'groupId': 'OG004'}, {'value': '-27.0', 'spread': '11.12', 'groupId': 'OG005'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-8.6', 'spread': '8.74', 'groupId': 'OG000'}, {'value': '-28.3', 'spread': '11.05', 'groupId': 'OG001'}, {'value': '-23.5', 'spread': '11.28', 'groupId': 'OG002'}, {'value': '-24.7', 'spread': '8.90', 'groupId': 'OG003'}, {'value': '-28.2', 'spread': '10.48', 'groupId': 'OG004'}, {'value': '-26.4', 'spread': '11.27', 'groupId': 'OG005'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-9.4', 'spread': '10.31', 'groupId': 'OG000'}, {'value': '-28.5', 'spread': '11.23', 'groupId': 'OG001'}, {'value': '-24.0', 'spread': '9.58', 'groupId': 'OG002'}, {'value': '-25.1', 'spread': '9.83', 'groupId': 'OG003'}, {'value': '-27.2', 'spread': '10.72', 'groupId': 'OG004'}, {'value': '-26.2', 'spread': '10.51', 'groupId': 'OG005'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-24.7', 'spread': '11.26', 'groupId': 'OG000'}, {'value': '-27.5', 'spread': '12.11', 'groupId': 'OG001'}, {'value': '-22.6', 'spread': '8.22', 'groupId': 'OG002'}, {'value': '-24.1', 'spread': '10.45', 'groupId': 'OG003'}, {'value': '-28.4', 'spread': '10.54', 'groupId': 'OG004'}, {'value': '-22.7', 'spread': '10.79', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 6 and Month 3.', 'description': 'Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.', 'unitOfMeasure': 'Percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is reduced due to missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Vehicle of DE-126) Followed by High Dose of DE-126', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks'}, {'id': 'OG001', 'title': '0.005% Latanoprost', 'description': '0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Ultra-low Dose 0.0005% DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Low Dose 0.001% DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Medium Dose 0.002% DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG005', 'title': 'High Dose 0.003% DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}], 'classes': [{'title': 'Week 1 9:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '3.65', 'groupId': 'OG001'}, {'value': '-5.3', 'spread': '2.65', 'groupId': 'OG002'}, {'value': '-6.0', 'spread': '3.10', 'groupId': 'OG003'}, {'value': '-6.7', 'spread': '3.70', 'groupId': 'OG004'}, {'value': '-6.6', 'spread': '3.24', 'groupId': 'OG005'}]}]}, {'title': 'Week 1 13:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '3.35', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '2.73', 'groupId': 'OG002'}, {'value': '-5.6', 'spread': '3.26', 'groupId': 'OG003'}, {'value': '-6.8', 'spread': '3.59', 'groupId': 'OG004'}, {'value': '-6.7', 'spread': '3.63', 'groupId': 'OG005'}]}]}, {'title': 'Week 1 17:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '3.33', 'groupId': 'OG001'}, {'value': '-5.6', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '-5.2', 'spread': '3.62', 'groupId': 'OG003'}, {'value': '-6.7', 'spread': '3.60', 'groupId': 'OG004'}, {'value': '-6.4', 'spread': '2.98', 'groupId': 'OG005'}]}]}, {'title': 'Week 2 9:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '4.03', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '3.52', 'groupId': 'OG002'}, {'value': '-6.2', 'spread': '3.00', 'groupId': 'OG003'}, {'value': '-6.9', 'spread': '3.32', 'groupId': 'OG004'}, {'value': '-6.4', 'spread': '3.66', 'groupId': 'OG005'}]}]}, {'title': 'Week 2 13:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '3.02', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '3.36', 'groupId': 'OG002'}, {'value': '-6.0', 'spread': '2.62', 'groupId': 'OG003'}, {'value': '-6.8', 'spread': '3.27', 'groupId': 'OG004'}, {'value': '-6.7', 'spread': '3.22', 'groupId': 'OG005'}]}]}, {'title': 'Week 2 17:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '3.39', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '3.36', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '2.52', 'groupId': 'OG003'}, {'value': '-6.9', 'spread': '3.29', 'groupId': 'OG004'}, {'value': '-6.3', 'spread': '3.15', 'groupId': 'OG005'}]}]}, {'title': 'Week 6 9:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '3.84', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '3.03', 'groupId': 'OG002'}, {'value': '-6.4', 'spread': '2.83', 'groupId': 'OG003'}, {'value': '-6.1', 'spread': '3.21', 'groupId': 'OG004'}, {'value': '-6.1', 'spread': '3.55', 'groupId': 'OG005'}]}]}, {'title': 'Week 6 13:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '3.30', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '3.65', 'groupId': 'OG002'}, {'value': '-6.2', 'spread': '2.64', 'groupId': 'OG003'}, {'value': '-6.8', 'spread': '3.67', 'groupId': 'OG004'}, {'value': '-6.8', 'spread': '3.11', 'groupId': 'OG005'}]}]}, {'title': 'Week 6 17:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '3.38', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '2.56', 'groupId': 'OG002'}, {'value': '-5.7', 'spread': '3.30', 'groupId': 'OG003'}, {'value': '-7.0', 'spread': '3.36', 'groupId': 'OG004'}, {'value': '-6.2', 'spread': '3.16', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 at 9:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-5.6', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '3.84', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '2.42', 'groupId': 'OG002'}, {'value': '-5.7', 'spread': '3.08', 'groupId': 'OG003'}, {'value': '-7.2', 'spread': '3.32', 'groupId': 'OG004'}, {'value': '-5.4', 'spread': '3.41', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 at 13:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '3.25', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '2.49', 'groupId': 'OG002'}, {'value': '-6.0', 'spread': '2.97', 'groupId': 'OG003'}, {'value': '-6.7', 'spread': '3.34', 'groupId': 'OG004'}, {'value': '-5.5', 'spread': '3.53', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 at 17:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-6.1', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '3.63', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '2.74', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '3.12', 'groupId': 'OG003'}, {'value': '-6.9', 'spread': '3.48', 'groupId': 'OG004'}, {'value': '-5.5', 'spread': '2.93', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.', 'description': 'Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is reduced due to missing data.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Vehicle of DE-126) Followed by High Dose of DE-126', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks'}, {'id': 'OG001', 'title': '0.005% Latanoprost', 'description': '0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Ultra-low Dose 0.0005% DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Low Dose 0.001% DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Medium Dose 0.002% DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG005', 'title': 'High Dose 0.003% DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}], 'classes': [{'title': 'Week 1 9:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-8.7', 'spread': '9.58', 'groupId': 'OG000'}, {'value': '-28.5', 'spread': '12.00', 'groupId': 'OG001'}, {'value': '-21.6', 'spread': '10.44', 'groupId': 'OG002'}, {'value': '-23.7', 'spread': '11.01', 'groupId': 'OG003'}, {'value': '-26.5', 'spread': '12.64', 'groupId': 'OG004'}, {'value': '-26.5', 'spread': '11.41', 'groupId': 'OG005'}]}]}, {'title': 'Week 1 13:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-5.3', 'spread': '10.75', 'groupId': 'OG000'}, {'value': '-27.3', 'spread': '11.41', 'groupId': 'OG001'}, {'value': '-23.3', 'spread': '11.09', 'groupId': 'OG002'}, {'value': '-22.8', 'spread': '12.54', 'groupId': 'OG003'}, {'value': '-28.0', 'spread': '12.43', 'groupId': 'OG004'}, {'value': '-27.0', 'spread': '13.50', 'groupId': 'OG005'}]}]}, {'title': 'Week 1 17:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-11.5', 'spread': '10.56', 'groupId': 'OG000'}, {'value': '-25.7', 'spread': '12.62', 'groupId': 'OG001'}, {'value': '-23.4', 'spread': '10.96', 'groupId': 'OG002'}, {'value': '-21.5', 'spread': '14.33', 'groupId': 'OG003'}, {'value': '-27.9', 'spread': '13.10', 'groupId': 'OG004'}, {'value': '-26.8', 'spread': '11.24', 'groupId': 'OG005'}]}]}, {'title': 'Week 2 9:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-7.8', 'spread': '10.30', 'groupId': 'OG000'}, {'value': '-28.9', 'spread': '13.13', 'groupId': 'OG001'}, {'value': '-21.7', 'spread': '13.84', 'groupId': 'OG002'}, {'value': '-24.5', 'spread': '10.62', 'groupId': 'OG003'}, {'value': '-27.4', 'spread': '11.69', 'groupId': 'OG004'}, {'value': '-25.6', 'spread': '13.56', 'groupId': 'OG005'}]}]}, {'title': 'Week 2 13:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '12.08', 'groupId': 'OG000'}, {'value': '-27.8', 'spread': '10.89', 'groupId': 'OG001'}, {'value': '-25.1', 'spread': '12.42', 'groupId': 'OG002'}, {'value': '-24.9', 'spread': '10.09', 'groupId': 'OG003'}, {'value': '-27.8', 'spread': '11.83', 'groupId': 'OG004'}, {'value': '-27.0', 'spread': '11.93', 'groupId': 'OG005'}]}]}, {'title': 'Week 2 17:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-9.9', 'spread': '10.16', 'groupId': 'OG000'}, {'value': '-27.8', 'spread': '12.69', 'groupId': 'OG001'}, {'value': '-23.5', 'spread': '12.42', 'groupId': 'OG002'}, {'value': '-24.4', 'spread': '9.53', 'groupId': 'OG003'}, {'value': '-28.8', 'spread': '12.48', 'groupId': 'OG004'}, {'value': '-26.3', 'spread': '11.95', 'groupId': 'OG005'}]}]}, {'title': 'Week 6 9:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-8.4', 'spread': '10.71', 'groupId': 'OG000'}, {'value': '-27.5', 'spread': '12.44', 'groupId': 'OG001'}, {'value': '-22.8', 'spread': '10.71', 'groupId': 'OG002'}, {'value': '-25.3', 'spread': '9.93', 'groupId': 'OG003'}, {'value': '-24.4', 'spread': '11.45', 'groupId': 'OG004'}, {'value': '-24.3', 'spread': '13.78', 'groupId': 'OG005'}]}]}, {'title': 'Week 6 13:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-8.6', 'spread': '10.89', 'groupId': 'OG000'}, {'value': '-28.8', 'spread': '12.25', 'groupId': 'OG001'}, {'value': '-24.5', 'spread': '12.69', 'groupId': 'OG002'}, {'value': '-25.6', 'spread': '9.85', 'groupId': 'OG003'}, {'value': '-27.7', 'spread': '12.16', 'groupId': 'OG004'}, {'value': '-27.8', 'spread': '11.27', 'groupId': 'OG005'}]}]}, {'title': 'Week 6 17:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-11.1', 'spread': '13.12', 'groupId': 'OG000'}, {'value': '-28.4', 'spread': '12.62', 'groupId': 'OG001'}, {'value': '-24.6', 'spread': '9.63', 'groupId': 'OG002'}, {'value': '-24.0', 'spread': '12.84', 'groupId': 'OG003'}, {'value': '-29.4', 'spread': '11.86', 'groupId': 'OG004'}, {'value': '-26.1', 'spread': '12.12', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 at 9:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-23.3', 'spread': '13.33', 'groupId': 'OG000'}, {'value': '-27.3', 'spread': '13.11', 'groupId': 'OG001'}, {'value': '-20.6', 'spread': '9.64', 'groupId': 'OG002'}, {'value': '-22.8', 'spread': '11.48', 'groupId': 'OG003'}, {'value': '-28.8', 'spread': '11.66', 'groupId': 'OG004'}, {'value': '-21.4', 'spread': '12.63', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 at 13:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-25.3', 'spread': '13.15', 'groupId': 'OG000'}, {'value': '-28.2', 'spread': '12.30', 'groupId': 'OG001'}, {'value': '-24.2', 'spread': '10.00', 'groupId': 'OG002'}, {'value': '-24.8', 'spread': '11.33', 'groupId': 'OG003'}, {'value': '-27.3', 'spread': '11.73', 'groupId': 'OG004'}, {'value': '-22.5', 'spread': '13.24', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 at 17:00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-25.4', 'spread': '11.12', 'groupId': 'OG000'}, {'value': '-26.8', 'spread': '14.63', 'groupId': 'OG001'}, {'value': '-22.7', 'spread': '10.37', 'groupId': 'OG002'}, {'value': '-24.3', 'spread': '12.06', 'groupId': 'OG003'}, {'value': '-28.7', 'spread': '12.82', 'groupId': 'OG004'}, {'value': '-23.4', 'spread': '11.96', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.', 'description': 'Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.', 'unitOfMeasure': 'Percentage of change in IOP', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is reduced due to missing data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Vehicle of DE-126) Followed by High Dose of DE-126', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks'}, {'id': 'OG001', 'title': '0.005% Latanoprost', 'description': '0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Ultra-low Dose 0.0005% DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Low Dose 0.001% DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Medium Dose 0.002% DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG005', 'title': 'High Dose 0.003% DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}], 'classes': [{'title': 'Week 1- At Least 20% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}]}, {'title': 'Week 1- At Least 25% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}]}, {'title': 'Week 1- At Least 30% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'Week 2- At Least 20% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}]}, {'title': 'Week 2- At Least 25% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}]}, {'title': 'Week 2- At Least 30% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}, {'title': 'Week 6- At Least 20% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}]}, {'title': 'Week 6- At Least 25% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}, {'title': 'Week 6- At Least 30% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}, {'title': 'Month 3- At Least 20% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Month 3- At Least 25% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'Month 3- At Least 30% Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'WeeK 1, Week 2, Week 6 and Month 3.', 'description': 'A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 20%.\n\nA Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 25%.\n\nA Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 30%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is reduced due to missing data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Vehicle of DE-126) Followed by High Dose of DE-126', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks'}, {'id': 'OG001', 'title': '0.005% Latanoprost', 'description': '0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG002', 'title': 'Ultra-low Dose 0.0005% DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG003', 'title': 'Low Dose 0.001% DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG004', 'title': 'Medium Dose 0.002% DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'OG005', 'title': 'High Dose 0.003% DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}], 'classes': [{'title': 'Week 1 -Reduced to 18 mmHg or Lower', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}]}, {'title': 'Week 2 -Reduced to 18 mmHg or Lower', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Week 6 -Reduced to 18 mmHg or Lower', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 -Reduced to 18 mmHg or Lower', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1, Week 2, Week 6 and Month 3.', 'description': 'A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants is reduced due to missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo (Vehicle of DE-126) Followed by High Dose of DE-126', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks'}, {'id': 'FG001', 'title': '0.005% Latanoprost', 'description': '0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'FG002', 'title': 'Ultra-low Dose 0.0005% DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'FG003', 'title': 'Low Dose 0.001% DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'FG004', 'title': 'Medium Dose 0.002% DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'FG005', 'title': 'High Dose 0.003% DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '44'}, {'groupId': 'FG005', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '43'}, {'groupId': 'FG005', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}, {'value': '241', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (Vehicle of DE-126) Followed by High Dose of DE-126', 'description': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks'}, {'id': 'BG001', 'title': '0.005% Latanoprost', 'description': '0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'BG002', 'title': 'Ultra-low Dose 0.0005% DE-126', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'BG003', 'title': 'Low Dose 0.001% DE-126', 'description': 'Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'BG004', 'title': 'Medium Dose 0.002% DE-126', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'BG005', 'title': 'High Dose 0.003% DE-126', 'description': 'Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '11.24', 'groupId': 'BG000'}, {'value': '64.4', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '65.5', 'spread': '13.30', 'groupId': 'BG002'}, {'value': '63.7', 'spread': '9.41', 'groupId': 'BG003'}, {'value': '61.0', 'spread': '11.84', 'groupId': 'BG004'}, {'value': '63.8', 'spread': '11.84', 'groupId': 'BG005'}, {'value': '63.6', 'spread': '11.22', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '135', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '106', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '209', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '114', 'groupId': 'BG006'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '127', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-16', 'size': 13901981, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-28T18:47', 'hasProtocol': True}, {'date': '2018-03-27', 'size': 901964, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-29T13:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2017-07-11', 'resultsFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2017-07-12', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-30', 'studyFirstPostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure in the Study Eye at Month 3', 'timeFrame': '9:00, 13:00 and 17:00 at Month 3', 'description': 'Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.'}], 'secondaryOutcomes': [{'measure': 'Intraocular Pressure in the Study Eye at Week 6', 'timeFrame': '9:00, 13:00 and 17:00 at Week 6', 'description': 'Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.'}, {'measure': 'Intraocular Pressure in the Study Eye at Week 1 and Week 2', 'timeFrame': '9:00, 13:00 and 17:00 at Week 1 and Week 2', 'description': 'Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.'}, {'measure': 'Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit', 'timeFrame': 'Week 1, Week 2, Week 6 and Month 3.', 'description': 'Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.'}, {'measure': 'Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit', 'timeFrame': 'Week 1, Week 2, Week 6 and Month 3.', 'description': 'Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.'}, {'measure': 'Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit', 'timeFrame': 'Week 1, Week 2, Week 6 and Month 3.', 'description': 'Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.'}, {'measure': 'Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit', 'timeFrame': '9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.', 'description': 'Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.'}, {'measure': 'Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit', 'timeFrame': '9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.', 'description': 'Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.'}, {'measure': 'Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit', 'timeFrame': 'WeeK 1, Week 2, Week 6 and Month 3.', 'description': 'A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 20%.\n\nA Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 25%.\n\nA Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 30%.'}, {'measure': 'Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit', 'timeFrame': 'Week 1, Week 2, Week 6 and Month 3.', 'description': 'A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glaucoma'], 'conditions': ['Open-angle Glaucoma, Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '35167779', 'type': 'DERIVED', 'citation': 'Wirta DL, Kuwayama Y, Lu F, Shao H, Odani-Kawabata N. Phase 2b, Randomized, 3-Month, Dose-Finding Study of Sepetaprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: The ANGEL Study. J Ocul Pharmacol Ther. 2022 Apr;38(3):240-251. doi: 10.1089/jop.2021.0077. Epub 2022 Feb 15.'}]}, 'descriptionModule': {'briefSummary': "Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss.\n\nThis study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension.\n\nThe IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide signed written informed consent\n* Diagnosis of POAG or OHT in both eyes\n* Qualifying corrected visual acuity in each eye\n* Qualifying central corneal thickness in each eye\n* Qualifying Day 1 IOP measurement at 3 time-points in both eyes\n* Qualifying Anterior chamber angle\n\nExclusion Criteria:\n\n* History of ocular surgery specifically intended to lower IOP\n* Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period\n* Advanced glaucoma in either eye\n* Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry\n* Any ocular surgery or ocular laser treatment within 90 days prior to Visit 1 (Screening) and throughout the study in either eye\n* Females who are pregnant, nursing, or planning a pregnancy'}, 'identificationModule': {'nctId': 'NCT03216902', 'briefTitle': 'A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen Inc.'}, 'officialTitle': 'A Phase IIb, Randomized, Observer-Masked, Placebo- and Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-126 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study', 'orgStudyIdInfo': {'id': '012601IN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Vehicle of DE-126) followed by high dose of DE-126', 'interventionNames': ['Drug: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Ultra-low dose 0.0005% DE-126', 'interventionNames': ['Drug: Topical ultra-low dose of DE-126 Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose 0.001% DE-126', 'interventionNames': ['Drug: Topical low dose of DE-126 Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Medium dose 0.002% DE-126', 'interventionNames': ['Drug: Topical medium dose of DE-126 Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'High dose 0.003% DE-126', 'interventionNames': ['Drug: Topical high dose of DE-126 Ophthalmic Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.005% Latanoprost', 'interventionNames': ['Drug: 0.005% Latanoprost Ophthalmic Solution']}], 'interventions': [{'name': 'Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution', 'type': 'DRUG', 'description': 'Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks', 'armGroupLabels': ['Placebo (Vehicle of DE-126) followed by high dose of DE-126']}, {'name': 'Topical ultra-low dose of DE-126 Ophthalmic Solution', 'type': 'DRUG', 'description': 'Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks', 'armGroupLabels': ['Ultra-low dose 0.0005% DE-126']}, {'name': 'Topical low dose of DE-126 Ophthalmic Solution', 'type': 'DRUG', 'description': 'Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks', 'armGroupLabels': ['Low dose 0.001% DE-126']}, {'name': 'Topical medium dose of DE-126 Ophthalmic Solution', 'type': 'DRUG', 'description': 'Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks', 'armGroupLabels': ['Medium dose 0.002% DE-126']}, {'name': 'Topical high dose of DE-126 Ophthalmic Solution', 'type': 'DRUG', 'description': 'Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks', 'armGroupLabels': ['High dose 0.003% DE-126']}, {'name': '0.005% Latanoprost Ophthalmic Solution', 'type': 'DRUG', 'otherNames': ['Xalatan®'], 'description': '0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks', 'armGroupLabels': ['0.005% Latanoprost']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90701', 'city': 'Artesia', 'state': 'California', 'country': 'United States', 'facility': 'Sall Research Medical Center, Inc', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'North Valley Eye Medical Group', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '92657', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation, INC', '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': '33773', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Shettle Eye Research, Inc.', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '30260', 'city': 'Morrow', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clayton Eye Clinical Research, LLC', 'geoPoint': {'lat': 33.58317, 'lon': -84.33937}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Coastal Research Associates, LLC', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Ophthalmological Group, PC', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mundorf Eye Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cornerstone Health Care, LLC', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Keystone Research Ltd SMO/Texan Eye, PA', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Keystone Research LTD SMO/Medical Center Ophthalmology Assoc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Fukuoka-shi, Fukuoka', 'country': 'Japan', 'facility': 'Murakami Karindoh Hospital'}, {'city': 'Nagoya-shi, Aichi', 'country': 'Japan', 'facility': 'Nagasaka Eye Clinic'}, {'city': 'Osaka-shi, Osaka', 'country': 'Japan', 'facility': 'Sugiura Eye Clinic'}, {'city': 'Sapporo-shi, Hokkaido', 'country': 'Japan', 'facility': 'Sapporo Katoh Ophthalmology Clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Shibuya-ku, Tokyo', 'country': 'Japan', 'facility': 'Dogenzaka Kato Eye Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}