Conditions: Glaucoma Ocular Hypertension
Keywords: AZARGA® Open angle glaucoma Prostaglandin Therapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 47
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.

Interventions: intervention 1: Brinzolamide 1% / timolol 0.5% Fixed Combination intervention 2: Habitual prostaglandin monotherapy
Intervention descriptions: intervention 1: None intervention 2: Topical ocular therapy used daily as prescribed

Protocol document: