Clinical trial

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

Name

883

Description

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

Trial arms

Trial start

2018-02-28

Estimated PCD

2018-11-17

Trial end

2018-11-17

Status

Completed

Phase

Early phase I

Treatment

brinzolamide 1% ophthalmic suspension

Arms:

Brinzolamide 1% ophthalmic suspension

Other names:

brinzolamide

Azopt 1%

Azopt 1%, RLD

Arms:

Azopt 1% ophthalmic suspension

Other names:

brinzolamide

Size

637

Primary endpoint

Intraocular Pressure (IOP)

6 weeks

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 637, 'type': 'ACTUAL'}}

Updated at

2023-05-09

2 organizations

5 products

3 indications

Organization

Merck Sharp & Dohme

Product

Ertugliflozin

Indication

Type 2 Diabetes Mellitus

Product