Cosopt Versus Xalacom

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273481
• Other study ID #: PRN 05-001
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2006
• Last updated: November 18, 2008
• Start date: September 2005
• Est. completion date: April 2007

Study information

• Verified date: November 2008
• Source: Pharmaceutical Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• dorzolamide 2%/timolol maleate 0.5% fixed combination

• latanoprost 0.005%/timolol maleate 0.5% fixed combination

• timolol maleate 0.5%

• placebo

Locations

Country	Name	City	State
Canada	Lawson Health Research Insitute	London	Ontario
Slovenia	University Eye Clinic	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaceutical Research Network

Countries where clinical trial is conducted

Canada,  Slovenia,