Overview

Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Treatments:
Adrenergic beta-Antagonists
Ophthalmic Solutions
Pharmaceutical Solutions
Timolol
Travoprost
Criteria
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.