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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 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 973 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02512042
The ClinicalTrials.gov registry entry for NCT02512042 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 973 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Test-Brinzolamide 1% Ophthalmic suspension is the first listed.
NCT02512042 reports 0 study locations.
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.
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