NCT03896633

Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 637 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Glaucoma
• Open Angle or Ocular Hypertension

Interventions

Type	Name	Description
DRUG	brinzolamide 1% ophthalmic suspension	brinzolamide 1% ophthalmic suspension
DRUG	Azopt 1%	Azopt 1%, RLD

Timeline

• Start date: 2018-02-28
• Primary completion: 2018-11-17
• Completion: 2018-11-17
• First posted: 2019-04-01
• Last updated: 2023-05-09
• Results posted: 2021-06-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study