SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)

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

Intervention: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension (Drug); Brinz/brim vehicle (Drug); Prostaglandin analogue (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Danyel Carr, MS, CCRA, Study Director, Affiliation: Alcon Research

Overall contact:
Alcon Call Center, Phone: 1-888-451-3937, Email: alcon.medinfo@alcon.com

The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0. 2% (dosed twice per day (BID)) when added to a PGA in patients with open-angle glaucoma or ocular hypertension.

Official title: Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue

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

Primary outcome: Mean change from baseline in diurnal IOP at Week 6

Secondary outcome:

Mean diurnal IOP at Week 6

Mean percentage change from baseline in diurnal IOP at Week 6

Mean change from baseline in IOP for each time point (09:00, 11:00, 16:00) at Week 6

Mean percentage change from baseline in IOP for each time point (09:00, 11:00, 16:00) at Week 6

Detailed description: This study consists of 2 sequential phases: Screening/Eligibility Phase, which includes a Run-in/Washout (Phase I), and Masked Treatment Phase (Phase II). At the Screening Visit, subjects will be assigned into one of 3 PGA therapy groups for the duration of the study. Subjects previously prescribed TRAVATAN®, XALATAN®, or LUMIGAN® monotherapy with uncontrolled IOP will not need a run-in period with PGA.

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

Criteria:

Inclusion Criteria:

- Diagnosis of either open-angle glaucoma or ocular hypertension;

- Must sign an informed consent form;

- Willing and able to attend all study visits;

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Women of childbearing potential who are pregnant, breast-feeding, intend to become

pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;

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

- Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified

in the protocol;

- Any other conditions including severe illness which would make the subject, in the

opinion of the Investigator, unsuitable for the study;

- Other protocol-specified exclusion criteria may apply.

Alcon Call Center, Phone: 1-888-451-3937, Email: alcon.medinfo@alcon.com

Contact Alcon Call Center for Trial Locations, Fort Worth, Texas 76134, United States; Recruiting

Starting date: August 2015
Last updated: August 11, 2015