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Clinical Trials/NCT07168902
NCT07168902
Recruiting
Phase 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 Incorporated8 sites in 1 country228 target enrollmentStarted: October 24, 2025Last updated:
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InterventionsBL1107 Low doseBL1107 High doseTimolol maleate 0.5%
DrugsBL1107 Low doseBL1107 High doseTimolol maleate 0.5%

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
228
Locations
8
Primary Endpoint
Change from baseline in visual field mean deviation in the study eye at Day 28/Exit.
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

  • Not provided

Exclusion Criteria

  • Not provided

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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (8)

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