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NCT03896633 Clinical Trial

Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

Glaucoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03896633
Other study ID # 883
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date February 28, 2018
Est. completion date November 17, 2018

Study information
Verified date May 2021
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with AzoptTM

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 637
Est. completion date November 17, 2018
Est. primary completion date November 17, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• brinzolamide 1% ophthalmic suspension
brinzolamide 1% ophthalmic suspension
• Azopt 1%
Azopt 1%, RLD

Locations
Country Name City State
United States Various Bridgewater New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Change in Intraocular Pressure (IOP) Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment. 6 weeks
Primary Intraocular Pressure (IOP) 6 weeks
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