Clinical trial

CD-11-265

Name

CD-11-265

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.

Trial arms

Trial start

2012-01-01

Estimated PCD

2012-09-01

Trial end

2012-09-01

Status

Completed

Phase

Early phase I

Treatment

brinzolamide 1% ophthalmic suspension

Arms:

Brinzolamide 1% ophthalmic suspension

Azopt 1%

Azopt 1%, RLD

Arms:

Azopt 1% ophthalmic suspension

Size

258

Primary endpoint

Intraocular Pressure (IOP) at Week 12

Week 12

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': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 258, 'type': 'ACTUAL'}}

Updated at

2023-05-09

1 organization

2 products

2 indications

Organization

Bausch & Lomb

Product

Azopt

Indication

Glaucoma

Indication

Open Angle or Ocular Hypertension

Product

Brinzolamide