Overview

Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z®

Status:
Completed
Trial end date:
2014-04-01
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 (TRAVATAN Z®).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Treatments:
Brimonidine Tartrate
Brinzolamide
Ophthalmic Solutions
Pharmaceutical Solutions
Travoprost
Criteria
Inclusion Criteria:

- Diagnosis of open angle glaucoma or ocular hypertension;

- Mean IOP measurements in at least 1 eye (study eye) of ≥ 21 mmHg and <32 mmHg at 8 AM
while on travoprost monotherapy at 2 consecutive visits (Eligibility 1 and Eligibility
2);

- Able to understand and sign Informed Consent form;

- 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.