RecruitingPhase 1NCT06267274

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

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


Sponsor

Amneal Pharmaceuticals, LLC

Enrollment

240 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two versions of the same eye drop medication to make sure a generic (copy) version works just as well as the brand-name version in lowering eye pressure in patients with glaucoma or high eye pressure in both eyes. **You may be eligible if...** - You are 18 or older - You have chronic open-angle glaucoma or elevated eye pressure (ocular hypertension) in both eyes - You need treatment in both eyes - You are able to stop your current eye pressure-lowering medications temporarily for a washout period before the study **You may NOT be eligible if...** - Your glaucoma requires treatment in only one eye - You have certain eye conditions that could interfere with the study results - You are pregnant or planning to become pregnant - You have had recent eye surgery 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.

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Interventions

DRUGBimatoprost 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.

DRUGLUMIGAN® (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

View Full Details on ClinicalTrials.gov

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NCT06267274


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