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NCT02512042 · ClinicalTrials.gov registry record · Phase 3

Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension to Azopt® 1% Ophthalmic Suspension In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes

A Phase 3 study, sponsored by Actavis.

Completed
Registry status
Phase 3
Development phase
973
Enrollment target

NCT02512042: Completed Phase 3 study, sponsored by Actavis.

NCT02512042 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 973 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02512042, a Phase 3 study, has completed, sponsored by Actavis.

COMPLETED
Registry status
Phase 3
Development phase
973 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • DRUG Test-Brinzolamide 1% Ophthalmic suspension
  • DRUG Reference-Brinzolamide 1% Ophthalmic suspension

Trial Details

FieldValue
Enrollment Target 973 participants
Start Date 2015-04
Est. Completion 2016-05
Phase Phase 3
Actavis

79 total trials

What the finished NCT02512042 record still lists

NCT02512042 is an interventional study that assigns participants to a tested intervention. The registered 973 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% higher).

The record links to 0 conditions, and to 2 interventions - of which Test-Brinzolamide 1% Ophthalmic suspension is the first listed.

NCT02512042 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02512042 about?

NCT02512042 is a clinical study titled "Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension to Azopt® 1% Ophthalmic Suspension 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 (Az...

What is the current status of trial NCT02512042?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 973 participants. The study started on 2015-04. Estimated completion is 2016-05.

What interventions are being tested in trial NCT02512042?

The interventions under investigation include: Test-Brinzolamide 1% Ophthalmic suspension (DRUG), Reference-Brinzolamide 1% Ophthalmic suspension (DRUG).

Who is sponsoring clinical trial NCT02512042?

This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02512042's enrollment target sits among peer trials

973 329th of 2000 higher than 1,672 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02512042, the US trial registry maintained by the National Library of Medicine. NCT02512042 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.