Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Maleic acid; Timolol; Travoprost

Criteria

Inclusion Criteria:

• Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma;

• Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye);

• On a stable medication regimen for IOP reduction one week prior to the screening visit;

• Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;

• Sign informed consent;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®;

• Any abnormality that would preclude the reliable performance of applanation tonometry in either eye;

• Infection in either eye;

• Conventional or laser intraocular surgery in either eye 3 months prior to screening visit;

• Risk for visual field or visual acuity worsening, in the opinion of the investigator;

• Women of childbearing potential;

• Pregnant or lactating women;

• Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant.

• Participation in another clinical study within 30 days before the screening visit;

• Other protocol-defined exclusion criteria may apply.