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RECRUITING
NCT05401357
PHASE3

Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.

Sponsor: Amneal Pharmaceuticals, LLC

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. Test Product - Bimatoprost ophthalmic solution, 0.01% of Amneal EU, Limited Reference Product - LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.

Official title: A Randomized, Double-blind, Multiple Dose, Parallel-group, Two-arm, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing 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

168

Start Date

2022-06-29

Completion Date

2022-12

Last Updated

2022-08-10

Healthy Volunteers

No

Interventions

DRUG

Test - Bimatoprost 0.01% Ophthalmic Solution

Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 1 hour for 42 days.

DRUG

Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)

Subjects in the other arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm for 42 days.

Locations (9)

Eye Research Foundation Inc.

Newport Beach, California, United States

North Bay Eye Associates, Inc.

Petaluma, California, United States

Volusia Eye Associates

New Smyrna Beach, Florida, United States

Clayton Eye Clinical Research, LLC

Morrow, Georgia, United States

Coastal Research Associates, LLC

Roswell, Georgia, United States

Toyos Clinic

Nashville, Tennessee, United States

Keystone Research

Austin, Texas, United States

Houston Eye Associates, North Loop

Houston, Texas, United States

Cheyenne Eye Clinic & Surgery Center

Cheyenne, Wyoming, United States