Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

May 7, 2023 updated by: Bausch & Lomb Incorporated
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • US01

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and females 18 years of age or older,
  • diagnosed with primary open-angle glaucoma or ocular hypertension.

Exclusion Criteria:

  • Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma,
  • ocular hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Azopt 1% ophthalmic suspension
Ophthalmic suspension
Drug: Azopt 1%
Azopt 1%, RLD
Experimental: Brinzolamide 1% ophthalmic suspension
ophthalmic suspension
Drug: brinzolamide 1% ophthalmic suspension
brinzolamide 1% ophthalmic suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular Pressure (IOP) at Week 12
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Intraocular Pressure (IOP) From Baseline to Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 7, 2023

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-11-265

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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