Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated; InnoPharma Inc.
• Treatments: Brinzolamide

Criteria

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.