Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

May 7, 2023 updated by: Bausch & Lomb Incorporated

A BIOEQUIVALENCE STUDY OF THE GENERIC BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION COMPARED TO REFERENCE LISTED DRUG AZOPT® (BRINZOLAMIDE) OPHTHALMIC SUSPENSION 1% IN SUBJECTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION

The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with AzoptTM

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Actual)

637

Phase

  • Phase 2
  • Phase 1

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
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Various

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

16 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
Other Names:
  • brinzolamide
Experimental: Brinzolamide 1% ophthalmic suspension
ophthalmic suspension
Drug: brinzolamide 1% ophthalmic suspension
brinzolamide 1% ophthalmic suspension
Other Names:
  • brinzolamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular Pressure (IOP)
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intraocular Pressure (IOP)
Time Frame: 6 weeks
Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment.
6 weeks

Collaborators and Investigators

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

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Lindsey Mathew, Bausch Health Americas, Inc.

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 (Actual)

February 28, 2018

Primary Completion (Actual)

November 17, 2018

Study Completion (Actual)

November 17, 2018

Study Registration Dates

First Submitted

March 28, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 7, 2023

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 883

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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