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

Condition(s) targeted: Ocular Hypertension; Open Angle Glaucoma

Intervention: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension (Drug); Vehicle (Drug); Travoprost 0.004% ophthalmic solution (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Steve Burmaster, PhD, Study Director, Affiliation: Alcon Research

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®).

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean Diurnal Intraocular Pressure (IOP) at Week 6

Secondary outcome:

Mean Diurnal IOP Change From Baseline to Week 6

Mean Diurnal IOP Percentage Change From Baseline to Week 6

Detailed description: This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Starting date: October 2013
Last updated: April 29, 2015