Fort Worth, Texas 76134


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Diagnosis of either open-angle glaucoma or ocular hypertension; - Must sign an informed consent form; - Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:00. - 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.


NCT ID:

NCT02419508


Primary Contact:

Study Director
Clinical Manager, Ophtha, GCRA
Alcon, a Novartis Company

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


Backup Contact:

N/A


Location Contact:

Fort Worth, Texas 76134
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.