Effect of SIMBRINZA™ As an Added Therapy to TRAVATAN Z®



Status:Completed
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:3/1/2014
Start Date:October 2013
End Date:October 2014
Contact:Alcon Call Center
Email:alcon.medinfo@alcon.com
Phone:1-888-451-3937

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Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination As Adjunctive Therapy to Travoprost

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

This study is divided into 2 sequential phases. The Screening/Eligibility phase includes one
screening visit and two eligibility visits, during which subjects will washout of all other
IOP-lowering medications and dose with TRAVATAN Z®, 1 drop instilled in each eye once daily
for 28 days. Subjects who meet all inclusion/exclusion criteria will be randomized at the
second eligibility visit. The Treatment phase consists of two on-therapy visits (Week 2 and
Week 6).

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 8 AM while on travoprost monotherapy at 2 consecutive visits
(Eligibility 1 and Eligibility 2);

- 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.
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1
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Fort Worth, Texas 76134
800 862 5266
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