NCT07168902CompletedPhase 2
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
Bausch & Lomb Incorporated22 sites in 1 country252 target enrollmentStarted: October 24, 2025Last updated:
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 252
- Locations
- 22
- Primary Endpoint
- Change from baseline in visual field mean deviation in the study eye at Day 28/Exit.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ocular hypertension or primary open-angle glaucoma in each eye
Exclusion Criteria
- •History of orthostatic hypotension
- •Any active ocular disease
- •Anticipated wearing of contact lenses during study
- •Contraindication to pupil dilation
Arms & Interventions
BL1107 Low dose
Experimental
Intervention: BL1107 Low dose (Drug)
BL1107 High dose
Experimental
Intervention: BL1107 High dose (Drug)
Timolol maleate 0.5%
Active Comparator
Intervention: Timolol maleate 0.5% (Drug)
Outcomes
Primary Outcomes
Change from baseline in visual field mean deviation in the study eye at Day 28/Exit.
Time Frame: Assessed at Day 28
Secondary Outcomes
- 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)
Investigators
Study Sites (22)
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