Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-25 @ 7:19 PM
Study NCT ID:
NCT05913232
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2023-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shinakazora@dwti.co.jp', 'phone': '+81-52-218-8785', 'title': 'Shigenobu Nakazora', 'organization': 'D. Western Therapeutics Institute, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'No significant limitations or caveats were reported for the study.'}}, 'adverseEventsModule': {'timeFrame': '28 days', 'description': 'Treatment-emergent adverse events (TEAE) are defined as AEs starting on or after the first dose of IP. A pre-existing event that worsens in severity after receiving the first dose of IP is treated as a new TEAE with date of onset set to the date of the increased severity.\n\nAn ocular event is an event where the site of the event is reported as both eyes (OU), right eye (OD) or left eye (OS).', 'eventGroups': [{'id': 'EG000', 'title': 'H-1337 0.6% Ophthalmic Solution b.i.d.', 'description': 'One drop H-1337 twice daily in the study eye for 28 days\n\nH-1337 0.6%: ophthalmic solution', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 19, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'H-1337 1.0% Ophthalmic Solution b.i.d.', 'description': 'One drop H-1337 twice daily in the study eye for 28 days\n\nH-1337 1.0%: ophthalmic solution', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 28, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.', 'description': 'One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days\n\nH-1337 1.0%: ophthalmic solution\n\nH-1337 Placebo: ophthalmic solution', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 29, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Timolol 0.5% Ophthalmic Solution b.i.d.', 'description': 'One drop Timolol twice daily in the study eye for 28 days\n\nTimolol 0.5%: ophthalmic solution', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 8, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Conjunctival hyperaemia', 'notes': 'Hyperemia was coded as conjunctival hyperemia if it was specifically indicated as occurring in the conjunctiva; all other cases of hyperemia were coded as ocular hyperemia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 25, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 30, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 44, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26)'}, {'term': 'Instillation site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy as Assessed by Change in Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}, {'units': 'study eyes', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'H-1337 0.6% Ophthalmic Solution b.i.d.', 'description': 'One drop H-1337 twice daily in the study eye for 28 days\n\nH-1337 0.6%: ophthalmic solution'}, {'id': 'OG001', 'title': 'H-1337 1.0% Ophthalmic Solution b.i.d.', 'description': 'One drop H-1337 twice daily in the study eye for 28 days\n\nH-1337 1.0%: ophthalmic solution'}, {'id': 'OG002', 'title': 'H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.', 'description': 'One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days\n\nH-1337 1.0%: ophthalmic solution\n\nH-1337 Placebo: ophthalmic solution'}, {'id': 'OG003', 'title': 'Timolol 0.5% Ophthalmic Solution b.i.d.', 'description': 'One drop Timolol twice daily in the study eye for 28 days\n\nTimolol 0.5%: ophthalmic solution'}], 'classes': [{'title': 'Day 28: Pre T0, change from baseline (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}, {'units': 'study eyes', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '3.15', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '3.45', 'groupId': 'OG002'}, {'value': '-7.0', 'spread': '3.26', 'groupId': 'OG003'}]}]}, {'title': 'Day 28: T0 + 2h, change from baseline (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}, {'units': 'study eyes', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '3.14', 'groupId': 'OG001'}, {'value': '-6.5', 'spread': '3.67', 'groupId': 'OG002'}, {'value': '-6.3', 'spread': '3.83', 'groupId': 'OG003'}]}]}, {'title': 'Day 28: T0 + 4h, change from baseline (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}, {'units': 'study eyes', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '3.24', 'groupId': 'OG001'}, {'value': '-6.8', 'spread': '3.48', 'groupId': 'OG002'}, {'value': '-5.3', 'spread': '3.53', 'groupId': 'OG003'}]}]}, {'title': 'Day 28: T0 + 8h, change from baseline (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}, {'units': 'study eyes', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.8', 'spread': '3.67', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '3.50', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '3.12', 'groupId': 'OG002'}, {'value': '-5.3', 'spread': '3.21', 'groupId': 'OG003'}]}]}, {'title': 'Day 28: T0 + 12h, change from baseline (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}, {'units': 'study eyes', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.6', 'spread': '3.82', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '3.37', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '3.44', 'groupId': 'OG002'}, {'value': '-4.9', 'spread': '3.35', 'groupId': 'OG003'}]}]}, {'title': 'Day 28: 8-hour diurnal, change from baseline (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}, {'units': 'study eyes', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.2', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '2.90', 'groupId': 'OG001'}, {'value': '-6.4', 'spread': '3.14', 'groupId': 'OG002'}, {'value': '-5.6', 'spread': '3.16', 'groupId': 'OG003'}]}]}, {'title': 'Day 28: 12-hour diurnal, change from baseline (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}, {'units': 'study eyes', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.8', 'spread': '3.02', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '2.76', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '3.11', 'groupId': 'OG002'}, {'value': '-5.4', 'spread': '2.99', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Mean change in intraocular pressure from baseline on Day 28 compared to timolol', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'study eyes', 'denomUnitsSelected': 'study eyes', 'populationDescription': 'Intent-to-Treat (ITT) is defined as all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Efficacy as Assessed by Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}, {'units': 'study eyes', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'H-1337 0.6% Ophthalmic Solution b.i.d.', 'description': 'One drop H-1337 twice daily in the study eye for 28 days\n\nH-1337 0.6%: ophthalmic solution'}, {'id': 'OG001', 'title': 'H-1337 1.0% Ophthalmic Solution b.i.d.', 'description': 'One drop H-1337 twice daily in the study eye for 28 days\n\nH-1337 1.0%: ophthalmic solution'}, {'id': 'OG002', 'title': 'H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.', 'description': 'One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days\n\nH-1337 1.0%: ophthalmic solution\n\nH-1337 Placebo: ophthalmic solution'}, {'id': 'OG003', 'title': 'Timolol 0.5% Ophthalmic Solution b.i.d.', 'description': 'One drop Timolol twice daily in the study eye for 28 days\n\nTimolol 0.5%: ophthalmic solution'}], 'classes': [{'title': 'Day 0: Pre T0', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.3'}]}]}, {'title': 'Day 0: T0 + 2h', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '13.5'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '13.7'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '10.9'}]}]}, {'title': 'Day 0: T0 + 4h', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.4'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.4'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '10.6'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '10.9'}]}]}, {'title': 'Day 0: T0 + 8h', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '16.2'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '13.5'}, {'value': '6.0', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '16.5'}, {'value': '6.1', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '16.9'}]}]}, {'title': 'Day 0: T0 + 12h', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '23.6'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '23.6'}, {'value': '15.2', 'groupId': 'OG002', 'lowerLimit': '6.3', 'upperLimit': '28.9'}, {'value': '13.3', 'groupId': 'OG003', 'lowerLimit': '5.1', 'upperLimit': '26.8'}]}]}, {'title': 'Day 0: 12-hour diurnal', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.4'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.4'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '10.6'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '10.9'}]}]}, {'title': 'Day 0: 8-hour diurnal', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.4'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '10.6'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '10.9'}]}]}, {'title': 'Day 1: Pre T0', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.3'}]}]}, {'title': 'Day 1: T0 + 2h', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '45.9'}, {'value': '35.3', 'groupId': 'OG001', 'lowerLimit': '22.4', 'upperLimit': '49.9'}, {'value': '28.0', 'groupId': 'OG002', 'lowerLimit': '16.2', 'upperLimit': '42.5'}, {'value': '46.9', 'groupId': 'OG003', 'lowerLimit': '32.5', 'upperLimit': '61.7'}]}]}, {'title': 'Day 1: T0 + 4h', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '36.6', 'upperLimit': '65.2'}, {'value': '58.8', 'groupId': 'OG001', 'lowerLimit': '44.2', 'upperLimit': '72.4'}, {'value': '70.0', 'groupId': 'OG002', 'lowerLimit': '55.4', 'upperLimit': '82.1'}, {'value': '63.3', 'groupId': 'OG003', 'lowerLimit': '48.3', 'upperLimit': '76.6'}]}]}, {'title': 'Day 1: T0 + 8h', 'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000', 'lowerLimit': '46.1', 'upperLimit': '74.2'}, {'value': '68.6', 'groupId': 'OG001', 'lowerLimit': '54.1', 'upperLimit': '80.9'}, {'value': '74.0', 'groupId': 'OG002', 'lowerLimit': '59.7', 'upperLimit': '85.4'}, {'value': '61.2', 'groupId': 'OG003', 'lowerLimit': '46.2', 'upperLimit': '74.8'}]}]}, {'title': 'Day 1: T0 + 12h', 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000', 'lowerLimit': '52.0', 'upperLimit': '80.5'}, {'value': '72.3', 'groupId': 'OG001', 'lowerLimit': '57.4', 'upperLimit': '84.4'}, {'value': '84.4', 'groupId': 'OG002', 'lowerLimit': '70.5', 'upperLimit': '93.5'}, {'value': '76.1', 'groupId': 'OG003', 'lowerLimit': '61.2', 'upperLimit': '87.4'}]}]}, {'title': 'Day 1: 12-hour diurnal', 'categories': [{'measurements': [{'value': '54.9', 'groupId': 'OG000', 'lowerLimit': '40.3', 'upperLimit': '68.9'}, {'value': '54.9', 'groupId': 'OG001', 'lowerLimit': '40.3', 'upperLimit': '68.9'}, {'value': '52.0', 'groupId': 'OG002', 'lowerLimit': '37.4', 'upperLimit': '66.3'}, {'value': '53.1', 'groupId': 'OG003', 'lowerLimit': '38.3', 'upperLimit': '67.5'}]}]}, {'title': 'Day 1: 8-hour diurnal', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000', 'lowerLimit': '32.9', 'upperLimit': '61.5'}, {'value': '51.0', 'groupId': 'OG001', 'lowerLimit': '36.6', 'upperLimit': '65.2'}, {'value': '52.0', 'groupId': 'OG002', 'lowerLimit': '37.4', 'upperLimit': '66.3'}, {'value': '53.1', 'groupId': 'OG003', 'lowerLimit': '38.3', 'upperLimit': '67.5'}]}]}, {'title': 'Day 7: Pre T0', 'categories': [{'measurements': [{'value': '37.3', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': '51.9'}, {'value': '30.0', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '44.6'}, {'value': '20.4', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': '34.3'}, {'value': '44.9', 'groupId': 'OG003', 'lowerLimit': '30.7', 'upperLimit': '59.8'}]}]}, {'title': 'Day 14: Pre T0', 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': '55.8'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '22.9', 'upperLimit': '50.8'}, {'value': '26.5', 'groupId': 'OG002', 'lowerLimit': '14.9', 'upperLimit': '41.1'}, {'value': '47.9', 'groupId': 'OG003', 'lowerLimit': '33.3', 'upperLimit': '62.8'}]}]}, {'title': 'Day 28: Pre T0', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '45.9'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '26.4', 'upperLimit': '54.8'}, {'value': '34.7', 'groupId': 'OG002', 'lowerLimit': '21.7', 'upperLimit': '49.6'}, {'value': '52.1', 'groupId': 'OG003', 'lowerLimit': '37.2', 'upperLimit': '66.7'}]}]}, {'title': 'Day 28: T0 + 2h', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '52.1', 'upperLimit': '79.2'}, {'value': '63.3', 'groupId': 'OG001', 'lowerLimit': '48.3', 'upperLimit': '76.6'}, {'value': '55.1', 'groupId': 'OG002', 'lowerLimit': '40.2', 'upperLimit': '69.3'}, {'value': '58.3', 'groupId': 'OG003', 'lowerLimit': '43.2', 'upperLimit': '72.4'}]}]}, {'title': 'Day 28: T0 + 4h', 'categories': [{'measurements': [{'value': '74.5', 'groupId': 'OG000', 'lowerLimit': '60.4', 'upperLimit': '85.7'}, {'value': '81.6', 'groupId': 'OG001', 'lowerLimit': '68.0', 'upperLimit': '91.2'}, {'value': '79.6', 'groupId': 'OG002', 'lowerLimit': '65.7', 'upperLimit': '89.8'}, {'value': '52.1', 'groupId': 'OG003', 'lowerLimit': '37.2', 'upperLimit': '66.7'}]}]}, {'title': 'Day 28: T0 + 8h', 'categories': [{'measurements': [{'value': '68.6', 'groupId': 'OG000', 'lowerLimit': '54.1', 'upperLimit': '80.9'}, {'value': '77.6', 'groupId': 'OG001', 'lowerLimit': '63.4', 'upperLimit': '88.2'}, {'value': '67.3', 'groupId': 'OG002', 'lowerLimit': '52.5', 'upperLimit': '80.1'}, {'value': '62.5', 'groupId': 'OG003', 'lowerLimit': '47.4', 'upperLimit': '76.0'}]}]}, {'title': 'Day 28: T0 + 12h', 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000', 'lowerLimit': '52.0', 'upperLimit': '80.5'}, {'value': '68.9', 'groupId': 'OG001', 'lowerLimit': '53.4', 'upperLimit': '81.8'}, {'value': '71.1', 'groupId': 'OG002', 'lowerLimit': '55.7', 'upperLimit': '83.6'}, {'value': '64.4', 'groupId': 'OG003', 'lowerLimit': '48.8', 'upperLimit': '78.1'}]}]}, {'title': 'Day 28: 12-hour diurnal', 'categories': [{'measurements': [{'value': '58.8', 'groupId': 'OG000', 'lowerLimit': '44.2', 'upperLimit': '72.4'}, {'value': '63.3', 'groupId': 'OG001', 'lowerLimit': '48.3', 'upperLimit': '76.6'}, {'value': '65.3', 'groupId': 'OG002', 'lowerLimit': '50.4', 'upperLimit': '78.3'}, {'value': '54.2', 'groupId': 'OG003', 'lowerLimit': '39.2', 'upperLimit': '68.6'}]}]}, {'title': 'Day 28: 8-hour diurnal', 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000', 'lowerLimit': '50.1', 'upperLimit': '77.6'}, {'value': '67.3', 'groupId': 'OG001', 'lowerLimit': '52.5', 'upperLimit': '80.1'}, {'value': '65.3', 'groupId': 'OG002', 'lowerLimit': '50.4', 'upperLimit': '78.3'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '35.2', 'upperLimit': '64.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0, Day 1, Day 7, Day 14, and Day 28', 'description': 'Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'study eyes', 'denomUnitsSelected': 'study eyes', 'populationDescription': 'Intent-to-Treat (ITT) is defined as all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Safety as Assessed by Adverse Event Reporting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'H-1337 0.6% Ophthalmic Solution b.i.d.', 'description': 'One drop H-1337 twice daily in the study eye for 28 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'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2023-06-12', 'resultsFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-26', 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy as Assessed by Change in Intraocular Pressure', 'timeFrame': 'Day 28', 'description': 'Mean change in intraocular pressure from baseline on Day 28 compared to timolol'}], 'secondaryOutcomes': [{'measure': 'Efficacy as Assessed by Intraocular Pressure', 'timeFrame': 'Day 0, Day 1, Day 7, Day 14, and Day 28', 'description': 'Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point'}, {'measure': 'Safety as Assessed by Adverse Event Reporting', 'timeFrame': 'Screening through Day 28', 'description': 'Percentage of participants with ocular and systemic adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma Open-Angle Primary', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The trial will evaluate the safety and efficacy of 3 dose regimens of H-1337 \\[0.6% twice daily (b.i.d.), 1.0% b.i.d. and 1.0% once in the morning (q.a.m.), and timolol maleate (0.5%, b.i.d.) in both eyes for 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of bilateral primary open angle glaucoma or ocular hypertension\n\nExclusion Criteria:\n\n* Closed or very narrow angles (Grades 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae \\>/= 180 degrees by gonioscopy within 6 months prior to screening visit in either eye\n\nNote: Other inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT05913232', 'briefTitle': 'Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'D. 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Western Therapeutics Institute, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}