Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

Bausch & Lomb Incorporated637 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

637

Conditions

Glaucoma Open Angle or Ocular Hypertension

Interventions

brinzolamide 1% ophthalmic suspensionDRUG

brinzolamide 1% ophthalmic suspension

Azopt 1%DRUG

Azopt 1%, RLD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Various

Bridgewater, New Jersey, United States

Outcomes

Primary Outcomes

Intraocular Pressure (IOP)

Time frame: 6 weeks

Data from ClinicalTrials.gov

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