Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

Prospective, Randomized, Multi-Center Study to Evaluate the Efficacy and Tolerability of DuoTrav® in Patients Previously Uncontrolled on a Beta-blocker

The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with open-angle glaucoma or ocular hypertension.

Inclusion Criteria:

• Have a clinical diagnosis of either open angle glaucoma or ocular hypertension.
• Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction.
• Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye.
• Must be able to understand and sign an Informed Consent form.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Use of medication excluded by the protocol.
• Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol.
• Ocular surgeries or procedures excluded by the protocol.
• Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
• Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator.
• Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
• Other protocol-specified exclusion criteria may apply.