NCT01263444

Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy

Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (AZARGA®) to Ocular Hypertensive or Glaucoma Patients Uncontrolled on Prostaglandin Monotherapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and efficacy of adding AZARGA® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma.

Detailed description

This study consisted of 3 study visits (Screening/Baseline, Week 4, and Week 12). Eligible patients self-administered the study medication (AZARGA® Eye Drops), adjunct to their current prostaglandin monotherapy for 3 months.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Brinzolamide 1% / timolol 0.5% Fixed Combination
DRUG	Habitual prostaglandin monotherapy	Topical ocular therapy used daily as prescribed

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-12-20
• Last updated: 2014-05-20
• Results posted: 2014-05-19