Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

Phase 3

Completed

• Conditions: Open Angle or Ocular Hypertension; Glaucoma
• Interventions: Drug: Azopt 1%; Drug: brinzolamide 1% ophthalmic suspension

• Registration Number: NCT01722604
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-07
• Disposition First Submitted: 2019-03-29
• Disposition First Submitted QC: 2019-03-29
• Disposition First Posted: 2019-04-04
• Results First Submitted: 2021-05-14
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-08
• Results First Posted: 2021-06-09
• Last Update Submitted: 2023-05-07
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azopt 1% ophthalmic suspension	Azopt 1%	Ophthalmic suspension
Brinzolamide 1% ophthalmic suspension	brinzolamide 1% ophthalmic suspension	ophthalmic suspension

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) at Week 12	Week 12

Secondary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP) From Baseline to Week 12	Baseline, Week 12

Trial Locations

Locations (1)

US01; 🇺🇸 Louisville, Kentucky, United States