Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

Bausch + Lomb

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glaucoma; Open Angle or Ocular Hypertension

Treatments: Drug: brinzolamide 1% ophthalmic suspension; Drug: Azopt 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03896633

883

Details and patient eligibility

About

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

Full 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.

Enrollment: 637 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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637 participants in 2 patient groups

Azopt 1% ophthalmic suspension

Active Comparator group

Description:

Ophthalmic suspension

Treatment:

Drug: Azopt 1%

Brinzolamide 1% ophthalmic suspension

Experimental group

Description:

ophthalmic suspension

Treatment:

Drug: brinzolamide 1% ophthalmic suspension