Cosopt Versus Xalacom

Phase 4

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension

• Registration Number: NCT00273481
• Lead Sponsor: Pharmaceutical Research Network

Brief Summary

To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus the LTFC given once every morning following a run-in period with timolol maleate given twice daily.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-01-06
• Study First Submitted QC: 2006-01-06
• Study First Posted: 2006-01-09
• Study Completion: 2007-04
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-18
• Last Update Posted: 2008-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• adults with primary open-angle or pigment-dispersion glaucoma, or ocular hypertension
• at baseline the intraocular pressure should be 20 to 32 mm Hg inclusive at 08:00 measurement (Visit 2) after dosing with timolol the evening before
• the intraocular pressure should be 32 mm Hg or less at all the time points in both eyes at Visit 2
• visual acuity should be 6/60 or better in the study eye(s)

Exclusion Criteria

• any anticipated change in systemic hypotensive therapy during the trial
• use of any corticosteroids by any route for more than two weeks during the study
• contraindications to study medicines

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Trial Locations

Locations (2)

Lawson Health Research Insitute; 🇨🇦 London, Ontario, Canada

University Eye Clinic; 🇸🇮 Ljubljana, Slovenia