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Study identifier: NCT05401357 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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.

Condition: Glaucoma, Open-Angle · Ocular Hypertension  ·  Sponsor: Amneal Pharmaceuticals, LLC

PhasePhase 3
Planned participants168
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Ilesh Changela, MBBS; MD  ·  +91-79-67778300  ·  ilesh@amnealindia.com

Always discuss trial participation with your own doctor first.

Locations (9)

Eye Research Foundation Inc.Newport Beach, California, United StatesRecruiting
North Bay Eye Associates, Inc.Petaluma, California, United StatesRecruiting
Volusia Eye AssociatesNew Smyrna Beach, Florida, United StatesRecruiting
Clayton Eye Clinical Research, LLCMorrow, Georgia, United StatesRecruiting
Coastal Research Associates, LLCRoswell, Georgia, United StatesRecruiting
Toyos ClinicNashville, Tennessee, United StatesRecruiting
Keystone ResearchAustin, Texas, United StatesNot Yet Recruiting
Houston Eye Associates, North LoopHouston, Texas, United StatesRecruiting
Cheyenne Eye Clinic & Surgery CenterCheyenne, Wyoming, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05401357