Overview

Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% to LUMIGANĀ® In The Treatment of Chronic Open-Angle Glaucoma

Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-masked, 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 Mankind Pharma Limited, India Reference Product - LUMIGANĀ® (Bimatoprost Ophthalmic Solution) 0.01% of Allergan, Inc.,
Phase:
Phase 3
Details
Lead Sponsor:
Mankind Pharma Limited
Collaborator:
CBCC Global Research
Treatments:
Bimatoprost
Ophthalmic Solutions
Pharmaceutical Solutions