Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT07168902
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2025-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2025-09-05', 'studyFirstSubmitQcDate': '2025-09-05', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in visual field mean deviation in the study eye at Day 28/Exit.', 'timeFrame': 'Assessed at Day 28'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants achieving ≥15-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit.', 'timeFrame': 'Assessed at Day 28'}, {'measure': 'Proportion of participants achieving ≥10-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit.', 'timeFrame': 'Assessed at Day 28'}, {'measure': 'Hour-matched change from Baseline in intraocular pressure (IOP) in the study eye at Day 28/Exit.', 'timeFrame': 'Assessed at Day 28'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults with Primary Open Angle Glaucoma or Ocular Hypertension', 'detailedDescription': 'This study will evaluate the safety and efficacy of BL1107 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This is a randomized, double-masked, parallel comparison to evaluate two concentrations of BL1107 in both eyes compared with timolol 0.5% for 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Ocular hypertension or primary open-angle glaucoma in each eye\n\nExclusion criteria:\n\n* History of orthostatic hypotension\n* Any active ocular disease\n* Anticipated wearing of contact lenses during study\n* Contraindication to pupil dilation'}, 'identificationModule': {'nctId': 'NCT07168902', 'briefTitle': 'Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Phase 2 Evaluation of the Safety, Ocular Tolerability, and Efficacy of Topical Ophthalmic BL1107 Versus Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'RX01-BL1107-1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BL1107 Low dose', 'interventionNames': ['Drug: BL1107 Low dose']}, {'type': 'EXPERIMENTAL', 'label': 'BL1107 High dose', 'interventionNames': ['Drug: BL1107 High dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol maleate 0.5%', 'interventionNames': ['Drug: Timolol maleate 0.5%']}], 'interventions': [{'name': 'BL1107 Low dose', 'type': 'DRUG', 'description': 'Dosed twice daily for 28 days.', 'armGroupLabels': ['BL1107 Low dose']}, {'name': 'BL1107 High dose', 'type': 'DRUG', 'description': 'Dosed twice daily for 28 days.', 'armGroupLabels': ['BL1107 High dose']}, {'name': 'Timolol maleate 0.5%', 'type': 'DRUG', 'description': 'Dosed twice daily for 28 days.', 'armGroupLabels': ['Timolol maleate 0.5%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91204', 'city': 'Glendale', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Global Research Management, Inc.', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Levenson Eye Associates', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Central Florida Eye Associates', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '33773', 'city': 'Largo', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Lee Shettle Eye and Hearing', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Scott & Christie and Associates, PC', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Total Eye Care, P.A.', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'centralContacts': [{'name': 'Johnson Varughese', 'role': 'CONTACT', 'email': 'Johnson.Varughese@bausch.com', 'phone': '9089271162'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}