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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.

Ocular Hypertension Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

Subjects with chronic open-angle glaucoma or ocular hypertension in both the eyes and meeting all the mentioned inclusion criteria and none of the exclusion criteria will be identified. At baseline (Day 0), subjects qualifying Intra Ocular Pressure (IOPs) following wash-out, with difference between the IOP in left and right eyes not being more than 5 mm Hg, will be randomized. Subjects will instill 1 drop of study drug (either T or R) in both eyes every evening at approximately 10:00 pm for 42 days. The study subjects will undergo clinical evaluations throughout the study in order to assess safety and efficacy. Primary endpoint evaluation will be assessed after 2 weeks (Day 14) and 6 weeks (Day 42) of treatment for each study subject deemed eligible for evaluation. The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05401357
Study type Interventional
Source Amneal Pharmaceuticals, LLC
Contact Ilesh Changela, MBBS; MD
Phone +91-79-67778300
Email ilesh@amnealindia.com
Status Recruiting
Phase Phase 3
Start date June 29, 2022
Completion date December 2022
View Details
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