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.
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.
- 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.
- 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.