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.

• Status: Not yet recruiting
• Trial end date: 2022-12-01

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.

• Phase: Phase 3

Details

• Lead Sponsor: Amneal Pharmaceuticals, LLC
• Collaborator: CBCC Global Research
• Treatments: Bimatoprost; Ophthalmic Solutions; Pharmaceutical Solutions