Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

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

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.

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.