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

NCT ID: NCT07168902

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-24

Study Completion Date

2026-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BL1107 Low dose

Group Type EXPERIMENTAL

BL1107 Low dose

Intervention Type DRUG

Dosed twice daily for 28 days.

BL1107 High dose

Group Type EXPERIMENTAL

BL1107 High dose

Intervention Type DRUG

Dosed twice daily for 28 days.

Timolol maleate 0.5%

Group Type ACTIVE_COMPARATOR

Timolol maleate 0.5%

Intervention Type DRUG

Dosed twice daily for 28 days.

Interventions

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BL1107 Low dose

Dosed twice daily for 28 days.

Intervention Type DRUG

BL1107 High dose

Dosed twice daily for 28 days.

Intervention Type DRUG

Timolol maleate 0.5%

Dosed twice daily for 28 days.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Global Research Management, Inc.

Glendale, California, United States

Site Status RECRUITING

Eye Research Foundation

Newport Beach, California, United States

Site Status RECRUITING

Levenson Eye Associates

Jacksonville, Florida, United States

Site Status NOT_YET_RECRUITING

Central Florida Eye Associates

Lakeland, Florida, United States

Site Status NOT_YET_RECRUITING

Lee Shettle Eye and Hearing

Largo, Florida, United States

Site Status RECRUITING

Andover Eye Associates

Andover, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Total Eye Care, P.A.

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Johnson Varughese

Role: CONTACT

Phone: 9089271162

Email: [email protected]

Other Identifiers

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RX01-BL1107-1201

Identifier Type: -

Identifier Source: org_study_id