A Phase III Study of Travoprost/Timolol Combination in Patients With Open-Angle Glaucoma or Ocular Hypertension

A Six-Week, Multi-Center, Double-Masked, Safety and Efficacy Study of Travoprost 0.004%/Timolol 0.5% BAC-free Compared to Travoprost 0.004%/Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997) and Japan (C-08-08, NCT00760539).

Inclusion Criteria:

• Open-angle glaucoma or confirmed ocular hypertension.
• Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 & 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 & 2.
• Sign an informed consent form.
• Discontinued use of all IOP-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the Eligibility 1 Visit.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures.
• Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension.
• History or current evidence of chronic or recurrent severe inflammatory eye disease in either eye.
• History or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
• Best-corrected visual acuity (BCVA) worse than 0.6 logMAR in either eye.
• Severe central visual field loss in either eye.
• Not able to safely discontinue use of all IOP-lowering ocular medication(s) according to the Ocular Hypotensive Medication Washout Schedule.
• History or current evidence of bronchial asthma, or severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude the safe administration of a topical beta-blocker.
• History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.
• Other protocol-defined exclusion criteria may apply.