CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 973 enrolled
Drug / intervention
Test-Brinzolamide 1% Ophthalmic suspension +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02512042
NCT02512042Phase 3Completed
CompareCT.gov

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

Actavis Inc.·interventional·Posted Jul 30, 2015·Updated Mar 2, 2020

In Brief

A Phase 3 clinical trial evaluating Test-Brinzolamide 1% Ophthalmic suspension and Reference-Brinzolamide 1% Ophthalmic suspension for Glaucoma. Completed, enrolled 973 participants across 10 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 30, 2015
Enrollment StartApr 1, 2015
Primary CompletionApr 1, 2016
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 10.9 years ago

Interventions

Test-Brinzolamide 1% Ophthalmic suspensiondrug

Reference-Brinzolamide 1% Ophthalmic suspensiondrug