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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 973 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-05 |
| Phase | Phase 3 |
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.
Learn More About Clinical Trials
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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