Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma Open Angle or Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Azopt 1% ophthalmic suspension

Ophthalmic suspension

Group Type ACTIVE_COMPARATOR

Azopt 1%

Intervention Type DRUG

Azopt 1%, RLD

Brinzolamide 1% ophthalmic suspension

ophthalmic suspension

Group Type EXPERIMENTAL

brinzolamide 1% ophthalmic suspension

Intervention Type DRUG

brinzolamide 1% ophthalmic suspension

Interventions

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brinzolamide 1% ophthalmic suspension

Intervention Type DRUG

Azopt 1%

Azopt 1%, RLD

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No