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

Bausch + Lomb

Status and phase: Enrolling; Phase 2

Conditions: Glaucoma

Treatments: Drug: BL1107 High dose; Drug: Timolol maleate 0.5%; Drug: BL1107 Low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT07168902

RX01-BL1107-1201

Details and patient eligibility

About

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

Full 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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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228 participants in 3 patient groups

BL1107 Low dose

Experimental group

Treatment:

Drug: BL1107 Low dose

BL1107 High dose

Experimental group

Treatment:

Drug: BL1107 High dose

Timolol maleate 0.5%

Active Comparator group

Treatment:

Drug: Timolol maleate 0.5%