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Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension
NCT07168902 · Bausch & Lomb Incorporated
In plain English
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Official title
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
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 228 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-10-24
Estimated completion: 2026-05
Last updated: 2026-03-31
Interventions
Drug: BL1107 Low doseDrug: BL1107 High doseDrug: Timolol maleate 0.5%
Primary outcomes
- • Change from baseline in visual field mean deviation in the study eye at Day 28/Exit. (Assessed at Day 28)
Sponsor
Bausch & Lomb Incorporated · industry
Contacts & investigators
ContactJohnson Varughese · contact · Johnson.Varughese@bausch.com · 9089271162
All locations (14)
Global Research Management, Inc.Recruiting
Glendale, California, United States
Eye Research FoundationRecruiting
Newport Beach, California, United States
California Eye Specialist Medical Group, LLCRecruiting
Pasadena, California, United States
Eye Associates of Fort MyersRecruiting
Fort Myers, Florida, United States
Levenson Eye AssociatesRecruiting
Jacksonville, Florida, United States
Central Florida Eye AssociatesRecruiting
Lakeland, Florida, United States
Lee Shettle Eye and HearingRecruiting
Largo, Florida, United States
Clayton Eye Clinical Research, LLCRecruiting
Morrow, Georgia, United States
Coastal Research Associates, LLCRecruiting
Roswell, Georgia, United States
Heart of America Eye CareRecruiting
Shawnee Mission, Kansas, United States
Andover Eye AssociatesRecruiting
Andover, Massachusetts, United States
Scott & Christie and Associates, PCRecruiting
Cranberry Township, Pennsylvania, United States
Total Eye Care, P.A.Recruiting
Memphis, Tennessee, United States
Houston Eye AssociatesRecruiting
Houston, Texas, United States