Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

Bausch & Lomb Incorporated258 enrolled

Overview

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

258

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)

US01

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Intraocular Pressure (IOP) at Week 12

Time frame: Week 12

Secondary Outcomes

Change in Intraocular Pressure (IOP) From Baseline to Week 12

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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