Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-25 @ 7:26 PM
Study NCT ID:
NCT02358369
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2015-01-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose-Ranging Study of the Bimatoprost Ocular Insert
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069580', 'term': 'Bimatoprost'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003008', 'term': 'Cloprostenol'}, {'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@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'No presentation or publication of Institution\'s data relating to the Trial may occur until after the Trial has been completed at all sites. If Investigator desires to present or publish, investigator must submit any and all manuscripts, posters, abstracts, or other intended publications (hereinafter collectively referred to as "manuscripts") to Sponsor at least sixty (60) days prior to the actual submission of such manuscript(s) for publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).', 'description': 'During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm.\n\nDuring the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).', 'eventGroups': [{'id': 'EG000', 'title': 'Washout + Placebo Ocular Insert', 'description': 'Glaucoma medication washout and placebo ocular insert in each eye for 4 to 6 weeks prior to randomization.', 'otherNumAtRisk': 156, 'otherNumAffected': 9, 'seriousNumAtRisk': 156, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Ocular Insert + Timolol 0.5%', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular inserts in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Inserts for 12 weeks.', 'otherNumAtRisk': 40, 'otherNumAffected': 16, 'seriousNumAtRisk': 40, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': '2.2 mg Bimatoprost Ocular Insert', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.', 'otherNumAtRisk': 40, 'otherNumAffected': 12, 'seriousNumAtRisk': 40, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': '13 mg Bimatoprost Ocular Insert', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.', 'otherNumAtRisk': 41, 'otherNumAffected': 20, 'seriousNumAtRisk': 41, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Brain hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Intraocular Pressure (IOP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Ocular Insert + Timolol 0.5% (Period A/B)', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG001', 'title': '2.2 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG002', 'title': '13 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}], 'classes': [{'title': 'Change from Baseline to Week 8 (T=0 hour)', 'categories': [{'measurements': [{'value': '-4.68', 'spread': '2.931', 'groupId': 'OG000'}, {'value': '-3.68', 'spread': '3.105', 'groupId': 'OG001'}, {'value': '-4.56', 'spread': '3.007', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 8 (T=2 hour)', 'categories': [{'measurements': [{'value': '-3.62', 'spread': '2.924', 'groupId': 'OG000'}, {'value': '-3.31', 'spread': '3.063', 'groupId': 'OG001'}, {'value': '-3.98', 'spread': '3.522', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 8 (T=8 hour)', 'categories': [{'measurements': [{'value': '-3.21', 'spread': '2.812', 'groupId': 'OG000'}, {'value': '-3.23', 'spread': '2.573', 'groupId': 'OG001'}, {'value': '-3.22', 'spread': '3.061', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) to Week 8', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 8. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 8.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in IOP at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Ocular Insert + Timolol 0.5% (Period A/B)', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG001', 'title': '2.2 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG002', 'title': '13 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}], 'classes': [{'title': 'Change from Baseline to Week 12 (T=0 hour)', 'categories': [{'measurements': [{'value': '-3.37', 'spread': '3.147', 'groupId': 'OG000'}, {'value': '-3.64', 'spread': '3.454', 'groupId': 'OG001'}, {'value': '-4.08', 'spread': '2.893', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12 (T=2 hour)', 'categories': [{'measurements': [{'value': '-2.74', 'spread': '2.891', 'groupId': 'OG000'}, {'value': '-3.67', 'spread': '3.182', 'groupId': 'OG001'}, {'value': '-3.40', 'spread': '3.815', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12 (T=8 hour)', 'categories': [{'measurements': [{'value': '-2.34', 'spread': '2.756', 'groupId': 'OG000'}, {'value': '-3.20', 'spread': '2.491', 'groupId': 'OG001'}, {'value': '-2.69', 'spread': '2.523', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) to Week 12', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 12. Participants on rescue therapy with missing data during the evaluation period or measurements out of the pre-specified visit window had IOP data imputed using LOCF (last observation carried forward) for the visit.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Ocular Insert + Timolol 0.5% (Period A/B)', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG001', 'title': '2.2 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG002', 'title': '13 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}], 'classes': [{'title': 'Right Eye, 10+ Letter Improvement', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Right Eye, 5+ Letter Improvement', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}, {'value': '5.6', 'groupId': 'OG002'}]}]}, {'title': 'Right Eye, No Change', 'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000'}, {'value': '69.2', 'groupId': 'OG001'}, {'value': '77.8', 'groupId': 'OG002'}]}]}, {'title': 'Right Eye, 5- Letter Worsening', 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}, {'value': '13.9', 'groupId': 'OG002'}]}]}, {'title': 'Right Eye, 10- Letter Worsening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, 10+ Letter Improvement', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5.6', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, 5+ Letter Improvement', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '20.5', 'groupId': 'OG001'}, {'value': '19.4', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, No Change', 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, 5- Letter Worsening', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}, {'value': '5.6', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, 10- Letter Worsening', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0) to Week 8', 'description': 'BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis at Week 8.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Ocular Insert + Timolol 0.5% (Period A/B)', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG001', 'title': '2.2 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG002', 'title': '13 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}], 'classes': [{'title': 'Right Eye, 10+ Letter Improvement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Right Eye, 5+ Letter Improvement', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '11.1', 'groupId': 'OG002'}]}]}, {'title': 'Right Eye, No Change', 'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000'}, {'value': '57.9', 'groupId': 'OG001'}, {'value': '61.1', 'groupId': 'OG002'}]}]}, {'title': 'Right Eye, 5- Letter Worsening', 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000'}, {'value': '28.9', 'groupId': 'OG001'}, {'value': '22.2', 'groupId': 'OG002'}]}]}, {'title': 'Right Eye, 10- Letter Worsening', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, 10+ Letter Improvement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5.6', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, 5+ Letter Improvement', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}, {'value': '19.4', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, No Change', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000'}, {'value': '68.4', 'groupId': 'OG001'}, {'value': '61.1', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, 5- Letter Worsening', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '15.8', 'groupId': 'OG001'}, {'value': '13.9', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, 10- Letter Worsening', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0) to Week 12', 'description': 'BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis at Week 12.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Ocular Insert + Timolol 0.5% (Period A/B)', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG001', 'title': '2.2 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG002', 'title': '13 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0) to Week 12', 'description': 'The clinician examined and graded the eyelids, conjunctiva, cornea and anterior chamber of the eye with the aid of a slit-lamp, (conjunctival erythema was assessed as part of the examination). Fluorescein dye was instilled into the ocular cul-de-sac to facilitate this examination.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who had an ocular insert placed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Automated Visual Field at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Ocular Insert + Timolol 0.5% (Period A/B)', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG001', 'title': '2.2 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG002', 'title': '13 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.58', 'spread': '3.377', 'groupId': 'OG000'}, {'value': '-1.45', 'spread': '4.041', 'groupId': 'OG001'}, {'value': '-2.70', 'spread': '2.934', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': '2.010', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '1.819', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '1.446', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) to Week 12', 'description': 'Automated Visual Field was examined used the Humphrey Visual Field Analyzer, a test that measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'decibels (dB)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all randomized participants who had an ocular insert placed. The number of participants analyzed is the number of participants with data available at the given time-point.'}, {'type': 'PRIMARY', 'title': 'Dilated Fundus Exam: Cup-to-Disc-Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Ocular Insert + Timolol 0.5% (Period A/B)', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG001', 'title': '2.2 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG002', 'title': '13 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}], 'classes': [{'title': 'Right Eye, Week 12', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.172', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.161', 'groupId': 'OG001'}, {'value': '0.47', 'spread': '0.184', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, Week 12', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.160', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.157', 'groupId': 'OG001'}, {'value': '0.48', 'spread': '0.176', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The cup-to-disk-ratio is an eye test to assess the progression of glaucoma. The diameter of the cup is compared to the diameter of the disk and a ratio is determined. The normal cup-disk ratio is 0.3. An increase in the cup-to-disc-ratio is a possible indication of glaucoma.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis. The number analyzed is the number of participants with data available at the given time-point.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Ocular Insert + Timolol 0.5% (Period A/B)', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG001', 'title': '2.2 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG002', 'title': '13 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}], 'classes': [{'title': 'Right Eye, None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}, {'value': '71.1', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000'}, {'value': '71.1', 'groupId': 'OG001'}, {'value': '47.2', 'groupId': 'OG002'}]}]}, {'title': 'Right Eye, Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}, {'value': '26.3', 'groupId': 'OG001'}, {'value': '44.4', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000'}, {'value': '26.3', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}]}]}, {'title': 'Right Eye, Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '5.6', 'groupId': 'OG002'}]}]}, {'title': 'Left Eye, Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Dilated fundus examination pathology findings were noted, described and graded on a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3). The percentage of participants in each grade is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all randomized participants who had an ocular insert placed. The number of participants analyzed is the number of participants with data available at the given time-point.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Ocular Insert + Timolol 0.5% (Period A/B)', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG001', 'title': '2.2 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG002', 'title': '13 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}], 'classes': [{'title': 'Ocular, Mild', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}, {'value': '26.8', 'groupId': 'OG002'}]}]}, {'title': 'Ocular, Moderate', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'Ocular, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Non-ocular, Mild', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'Non-Ocular, Moderate', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'Non-ocular, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0) to Week 12', 'description': 'An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. Th investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all randomized participants who had an ocular insert placed.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13 mg Bimatoprost Ocular Insert (Period C)', 'description': 'Following Treatment Period A/B, 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks in Period C (Week 12 to Week 24).'}], 'classes': [{'title': 'Ocular, Mild', 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}]}]}, {'title': 'Ocular, Moderate', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Ocular, Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non-ocular, Mild', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Non-ocular, Moderate', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Non-ocular, Severe', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 to Week 24', 'description': 'An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all randomized participants who had an ocular insert placed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IOP at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Ocular Insert + Timolol 0.5% (Period A/B)', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG001', 'title': '2.2 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG002', 'title': '13 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}], 'classes': [{'title': 'Change from Baseline to Week 2 (T=0 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.84', 'spread': '2.264', 'groupId': 'OG000'}, {'value': '-4.56', 'spread': '3.134', 'groupId': 'OG001'}, {'value': '-5.95', 'spread': '2.367', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 2 (T=2 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.71', 'spread': '2.277', 'groupId': 'OG000'}, {'value': '-4.14', 'spread': '2.637', 'groupId': 'OG001'}, {'value': '-5.34', 'spread': '2.499', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 2 (T=8 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.81', 'spread': '2.612', 'groupId': 'OG000'}, {'value': '-3.76', 'spread': '2.320', 'groupId': 'OG001'}, {'value': '-4.52', 'spread': '2.594', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) to Week 2', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IOP at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Ocular Insert + Timolol 0.5% (Period A/B)', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG001', 'title': '2.2 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'OG002', 'title': '13 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}], 'classes': [{'title': 'Change from Baseline to Week 6 (T=0 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.42', 'spread': '2.770', 'groupId': 'OG000'}, {'value': '-4.87', 'spread': '3.212', 'groupId': 'OG001'}, {'value': '-5.30', 'spread': '2.941', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 6 (T=2 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.97', 'spread': '2.948', 'groupId': 'OG000'}, {'value': '-4.40', 'spread': '3.138', 'groupId': 'OG001'}, {'value': '-4.42', 'spread': '2.830', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 6 (T=8 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.40', 'spread': '2.529', 'groupId': 'OG000'}, {'value': '-3.73', 'spread': '2.393', 'groupId': 'OG001'}, {'value': '-3.77', 'spread': '2.291', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) to Week 6', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 6.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IOP in Period C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13 mg Bimatoprost Ocular Insert (Period C)', 'description': 'Following Treatment Period A/B, 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks in Period C (Week 12 to Week 24).'}], 'classes': [{'title': 'Change from Baseline to Week 14 (T=0 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.72', 'spread': '2.919', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Week 14 (T=2 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.64', 'spread': '3.100', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Week 14 (T=8 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.13', 'spread': '2.849', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Week 18 (T=0 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.62', 'spread': '3.135', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Week 18 (T=2 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.33', 'spread': '3.072', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Week 18 (T=8 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.17', 'spread': '2.714', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Week 24 (T=0 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.85', 'spread': '2.882', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Week 24 (T=2 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.99', 'spread': '2.847', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Week 24 (T=8 hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.99', 'spread': '3.010', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) to Weeks 14, 18 and 24', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 14, 18 and 24. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at the given timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Washout + Placebo Ocular Insert', 'description': 'Glaucoma medication washout and placebo ocular insert in each eye for 4 to 6 weeks prior to randomization.'}, {'id': 'FG001', 'title': 'Placebo Ocular Insert + Timolol 0.5% (Period A/B)', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'FG002', 'title': '2.2 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'FG003', 'title': '13 mg Bimatoprost Ocular Insert (Period A/B)', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued.'}, {'id': 'FG004', 'title': '13 mg Bimatoprost Ocular Insert (Period C)', 'description': 'Following Treatment Period A/B, 13 mg Bimatoprost Ocular Insert for 12 weeks in Period C (Week 12 to 24).'}], 'periods': [{'title': 'Pre-Randomization Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Not Qualified for Randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period A/B', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period C', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': '156 participants were enrolled and entered the washout placebo and trial-wear period. A total of 121 participants were randomized to one of three treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Ocular Insert + Timolol 0.5%', 'description': 'Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular inserts in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Inserts for 12 weeks.'}, {'id': 'BG001', 'title': '2.2 mg Bimatoprost Ocular Insert', 'description': 'Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.'}, {'id': 'BG002', 'title': '13 mg Bimatoprost Ocular Insert', 'description': 'Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.7', 'spread': '8.70', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '9.24', 'groupId': 'BG001'}, {'value': '63.0', 'spread': '10.01', 'groupId': 'BG002'}, {'value': '64.9', 'spread': '9.47', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized, treated and returned for at least one post-treatment visit.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'dispFirstSubmitDate': '2016-10-21', 'completionDateStruct': {'date': '2015-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2015-01-21', 'dispFirstSubmitQcDate': '2016-10-24', 'resultsFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2015-02-06', 'dispFirstPostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-18', 'studyFirstPostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Intraocular Pressure (IOP) at Week 8', 'timeFrame': 'Baseline (Day 0) to Week 8', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 8. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.'}, {'measure': 'Change From Baseline in IOP at Week 12', 'timeFrame': 'Baseline (Day 0) to Week 12', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.'}, {'measure': 'Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8', 'timeFrame': 'Baseline (Day 0) to Week 8', 'description': 'BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.'}, {'measure': 'Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12', 'timeFrame': 'Baseline (Day 0) to Week 12', 'description': 'BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.'}, {'measure': 'Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12', 'timeFrame': 'Baseline (Day 0) to Week 12', 'description': 'The clinician examined and graded the eyelids, conjunctiva, cornea and anterior chamber of the eye with the aid of a slit-lamp, (conjunctival erythema was assessed as part of the examination). Fluorescein dye was instilled into the ocular cul-de-sac to facilitate this examination.'}, {'measure': 'Change From Baseline in Automated Visual Field at Week 12', 'timeFrame': 'Baseline (Day 0) to Week 12', 'description': 'Automated Visual Field was examined used the Humphrey Visual Field Analyzer, a test that measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive change from Baseline indicates improvement.'}, {'measure': 'Dilated Fundus Exam: Cup-to-Disc-Ratio', 'timeFrame': 'Week 12', 'description': 'The cup-to-disk-ratio is an eye test to assess the progression of glaucoma. The diameter of the cup is compared to the diameter of the disk and a ratio is determined. The normal cup-disk ratio is 0.3. An increase in the cup-to-disc-ratio is a possible indication of glaucoma.'}, {'measure': 'Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12', 'timeFrame': 'Week 12', 'description': 'Dilated fundus examination pathology findings were noted, described and graded on a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3). The percentage of participants in each grade is reported.'}, {'measure': 'Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B', 'timeFrame': 'Baseline (Day 0) to Week 12', 'description': 'An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. Th investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.'}, {'measure': 'Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C', 'timeFrame': 'Week 12 to Week 24', 'description': 'An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in IOP at Week 2', 'timeFrame': 'Baseline (Day 0) to Week 2', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.'}, {'measure': 'Change From Baseline in IOP at Week 6', 'timeFrame': 'Baseline (Day 0) to Week 6', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.'}, {'measure': 'Change From Baseline in IOP in Period C', 'timeFrame': 'Baseline (Day 0) to Weeks 14, 18 and 24', 'description': 'IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 14, 18 and 24. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Open-Angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension.\n\nThis study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Written informed consent\n* At least 18 years of age\n* Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension\n* Best corrected-distance visual acuity score equivalent to 20/80 or better\n* Stable visual field\n* Central corneal thickness between 490 - 620 micrometers\n\nInclusion Criteria at the Randomization Visit:\n\n("T" is defined as time and "hr" is defined as hour\\[s\\])\n\n* IOP for each eye is ≥ 23 mm Hg at T=0 hr, ≥ 20 mm Hg at T=2 hr and T=8 hr.\n* Inter-eye IOP difference of ≤ 5.0 mm Hg at T=0 hr, T=2 hr and T=8 hr.\n* IOP for each eye is ≤ 30 mm Hg at T=0 hr, T=2 hr and T=8 hr.\n\nKey Exclusion Criteria:\n\n* Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol\n* A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of beta-blocker drops\n* Cup-to-disc ratio of greater than 0.8\n* Significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than Grade 2 based on gonioscopy\n* Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date\n* Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months\n* Past history of any incisional surgery for glaucoma at any time\n* Past history of corneal refractive surgery\n* Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer\n* Current participation in an investigational drug or device study or participation in such a study within 30 days of Screening\n* Inability to adequately evaluate the retina\n* Participants who will require contact lens use during the study period.\n* Participants who currently have punctal occlusion\n* Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control'}, 'identificationModule': {'nctId': 'NCT02358369', 'briefTitle': 'Dose-Ranging Study of the Bimatoprost Ocular Insert', 'organization': {'class': 'INDUSTRY', 'fullName': 'ForSight Vision5, Inc.'}, 'officialTitle': 'A Phase 2 Prospective, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety and Dose-response of the Bimatoprost Ocular Insert (2.2 mg, 13 mg) With and Without Concomitant Artificial Tears Compared to a Placebo Ocular Insert With and Without Concomitant Timolol (0.5%) Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'FSV5-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '13 mg Bimatoprost Ocular Insert', 'description': 'Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye (OU) for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops to each eye twice a day (BID) for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.', 'interventionNames': ['Drug: Bimatoprost', 'Device: Placebo Ocular Insert', 'Drug: Placebo Eye Drops']}, {'type': 'EXPERIMENTAL', 'label': '2.2 mg Bimatoprost Ocular Insert', 'description': 'Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 2.2 mg Bimatoprost Ocular Insert in each eye for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops in each eye twice a day for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.', 'interventionNames': ['Drug: Bimatoprost', 'Device: Placebo Ocular Insert', 'Drug: Placebo Eye Drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol 0.5%', 'description': 'Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 0.5% timolol ophthalmic solution in each eye for 6 weeks. Note: participants simultaneously wore placebo ocular inserts for 12 weeks.\n\nAfter 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.', 'interventionNames': ['Drug: Bimatoprost', 'Drug: Timolol 0.5%', 'Device: Placebo Ocular Insert']}], 'interventions': [{'name': 'Bimatoprost', 'type': 'DRUG', 'description': 'Bimatoprost sustained release Ocular Insert', 'armGroupLabels': ['13 mg Bimatoprost Ocular Insert', '2.2 mg Bimatoprost Ocular Insert', 'Timolol 0.5%']}, {'name': 'Timolol 0.5%', 'type': 'DRUG', 'description': 'BID drops OU, 0.5% ophthalmic solution', 'armGroupLabels': ['Timolol 0.5%']}, {'name': 'Placebo Ocular Insert', 'type': 'DEVICE', 'description': 'Placebo ocular insert OU.', 'armGroupLabels': ['13 mg Bimatoprost Ocular Insert', '2.2 mg Bimatoprost Ocular Insert', 'Timolol 0.5%']}, {'name': 'Placebo Eye Drops', 'type': 'DRUG', 'description': 'Placebo eye drops BID OU.', 'armGroupLabels': ['13 mg Bimatoprost Ocular Insert', '2.2 mg Bimatoprost Ocular Insert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Vold Vision', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90701', 'city': 'Artesia', 'state': 'California', 'country': 'United States', 'facility': 'Sall Medical Research Center', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '30260', 'city': 'Morrow', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clayton Eye Center', 'geoPoint': {'lat': 33.58317, 'lon': -84.33937}}, {'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', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '45243', 'city': 'Madeira', 'state': 'Ohio', 'country': 'United States', 'facility': 'Apex Eye', 'geoPoint': {'lat': 39.19089, 'lon': -84.36355}}, {'zip': '37803', 'city': 'Maryville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Eye Specialists', 'geoPoint': {'lat': 35.75647, 'lon': -83.97046}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'R&R Eye Research, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Michelle Chen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ForSight Vision5, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}