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

Alcon

Status and phase

Completed

Phase 3

Conditions

Open-Angle Glaucoma

Ocular Hypertension

Treatments

Drug: Travoprost 0.004%/Timolol 0.5% ophthalmic solution

Drug: Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT00672997

C-07-64

Details and patient eligibility

About

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).

Enrollment

301 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.