Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Brimonidine Tartrate; Brinzolamide; Travoprost

Criteria

Inclusion Criteria:

• Diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;

• Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21 mmHg and <32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);

• Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01% monotherapy for at least 28 days prior to the Screening Visit;

• Able to understand and sign Informed Consent Document;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;

• Any form of glaucoma other than open angle glaucoma or ocular hypertension;

• Severe central visual field loss;

• Chronic, recurrent, or severe inflammatory eye disease;

• Ocular trauma within the past 6 months;

• Ocular infection or ocular inflammation within the past 3 months;

• Best-corrected visual acuity score worse than approximately 20/80 Snellen;

• Eye surgery within the past 6 months;

• Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;

• Use of any additional topical or systemic ocular hypertensive medication during the study;

• Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;

• Other protocol-defined exclusion criteria may apply.