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RECRUITING
NCT06267274
PHASE1

A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

Sponsor: Amneal Pharmaceuticals, LLC

View on ClinicalTrials.gov

Summary

A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study

Official title: A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing Generic Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-04-01

Completion Date

2025-05-01

Last Updated

2024-08-06

Healthy Volunteers

No

Interventions

DRUG

Bimatoprost Ophthalmic Solution, 0.01%

1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule.

DRUG

LUMIGAN® (bimatoprost ophthalmic solution) 0.01%

1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule.

Locations (4)

West Coast Eye Institute

Bakersfield, California, United States

Eye Research Foundation

Newport Beach, California, United States

Clayton Eye Research

Morrow, Georgia, United States

Houston Eye Associates

Houston, Texas, United States