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
Amneal Pharmaceuticals, LLC
168 participants
Jun 29, 2022
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
Plain Language Summary
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Interventions
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.
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)
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NCT05401357