Overview

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

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
Timolol
Travoprost
Criteria
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.