Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension

Bausch & Lomb Incorporated252 enrolled

Overview

Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults with Primary Open Angle Glaucoma or Ocular Hypertension

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

252

Conditions

Glaucoma

Interventions

BL1107 Low doseDRUG

Dosed twice daily for 28 days.

BL1107 High doseDRUG

Dosed twice daily for 28 days.

Timolol maleate 0.5%DRUG

Dosed twice daily for 28 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Global Research Management, Inc.

Glendale, California, United States

Eye Research Foundation

Newport Beach, California, United States

California Eye Specialist Medical Group, LLC

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.

Time frame: 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.

Time frame: Assessed at Day 28

Hour-matched change from Baseline in intraocular pressure (IOP) in the study eye at Day 28/Exit.

Time frame: Assessed at Day 28

Data from ClinicalTrials.gov

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