Skip to main content
OpenTrials
Completed

NCT Number: NCT03896633

Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension Open Angle or Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Various

Bridgewater, New Jersey, 08807, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brinzolamide 1% ophthalmic suspension

Drug

brinzolamide 1% ophthalmic suspension

Other names: brinzolamide

Azopt 1%

Drug

Azopt 1%, RLD

Other names: brinzolamide

Primary outcomes

  1. Intraocular Pressure (IOP)

    Time frame: 6 weeks

Other outcomes

  1. Change in Intraocular Pressure (IOP)

    Time frame: 6 weeks

    Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 1, 2019
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.