RecruitingPhase 3NCT05401357

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.

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


Sponsor

Amneal Pharmaceuticals, LLC

Enrollment

168 participants

Start Date

Jun 29, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a generic version of bimatoprost 0.01% eye drops to the brand-name product LUMIGAN®, to confirm they work equally well at lowering eye pressure in people with glaucoma or high eye pressure. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with chronic open-angle glaucoma or high eye pressure (ocular hypertension) in both eyes - You require treatment in both eyes - You are able to stop other eye pressure medications before starting the study **You may NOT be eligible if...** - You have other types of glaucoma (e.g., narrow-angle, secondary glaucoma) - You have had eye surgery within the past 6 months - You have a known allergy to bimatoprost or any component of the eye drops - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTest - 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.

DRUGReference - 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05401357


Related Trials