Completed
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
What is being tested
brinzolamide 1% ophthalmic suspension
+ Azopt 1%
Drug
Who is being recruted
Eye Diseases
+ Glaucoma
+ Ocular Hypertension
Over 18 Years
+4 Eligibility Criteria
How is the trial designed
Services Research Study
Phase 3
Interventional
Study Start: January 2012
Summary
Principal SponsorBausch & Lomb Incorporated
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2012
Actual date on which the first participant was enrolled.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.
Official TitleTherapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Principal SponsorBausch & Lomb Incorporated
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
258 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Services Research Study
These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Eye DiseasesGlaucomaOcular Hypertension
Criteria
2 inclusion criteria required to participate
diagnosed with primary open-angle glaucoma or ocular hypertension.
Male and females 18 years of age or older,
2 exclusion criteria prevent from participating
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
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimentalophthalmic suspension
Group II
Active ComparatorOphthalmic suspension
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center