Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension
Not Applicable
Not yet recruiting
- Conditions
- Glaucoma
- Interventions
- Registration Number
- NCT07168902
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults with Primary Open Angle Glaucoma or Ocular Hypertension
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 228
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BL1107 Low dose BL1107 Low dose - BL1107 High dose BL1107 High dose - Timolol maleate 0.5% Timolol maleate 0.5% -
- Primary Outcome Measures
Name Time Method Change from baseline in visual field mean deviation in the study eye at Day 28/Exit. Assessed at Day 28
- Secondary Outcome Measures
Name Time Method Proportion of participants achieving ≥15-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit. Assessed at Day 28 Proportion of participants achieving ≥10-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit. Assessed at Day 28 Hour-matched change from Baseline in intraocular pressure (IOP) in the study eye at Day 28/Exit. Assessed at Day 28