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A Multicentre, Double Blind, Active Controlled, Parallel Group, Two Arm, Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension (Manufactured by Indoco Remedies Ltd. for Watson Pharma Pvt Ltd.), to Brinzolamide (Azopt®) 1% Ophthalmic Suspension of Alcon Laboratories, Inc., In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes
This is a randomized, double blind, two-arm, parallel group, active controlled bioequivalence study, at multiple clinical trial sites designed to demonstrate bioequivalence of Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies Ltd. for Watson Pharma Pvt Ltd.), to Brinzolamide (Azopt®) 1% ophthalmic suspension of Alcon Laboratories, Inc. in the treatment of chronic open angle glaucoma or ocular hypertension in both eyes.
Details
| Lead sponsor | Actavis Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 973 |
| Start date | 2015-04 |
| Completion | 2016-05 |
Conditions
- Glaucoma
Interventions
- Test-Brinzolamide 1% Ophthalmic suspension
- Reference-Brinzolamide 1% Ophthalmic suspension
Primary outcomes
- Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points — Day 14 and 42 at 8AM and 10AM
The primary efficacy end point is the mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups at four time points, i.e., at approximately 8:00 am (hour 0; before the morning drop) and 10:00 am (hour 2; after the morning drop) at the Day 14 (week 2) and Day 42 (week 6) visits
Countries
United States