Cosopt Versus Xalacom

Sponsor

Pharmaceutical Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT00273481

Collaborator

(none)

Enrollment

Locations

Duration (Months)

16.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: dorzolamide 2%/timolol maleate 0.5% fixed combination Drug: latanoprost 0.005%/timolol maleate 0.5% fixed combination Drug: timolol maleate 0.5% Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2005

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lawson Health Research Insitute	London	Ontario	Canada	N6A 4G5
2	University Eye Clinic	Ljubljana		Slovenia	A525

Sponsors and Collaborators

Pharmaceutical Research Network

Investigators

Study Director: William C. Stewart, MD, Pharmaceutical Research Network, LLC
Principal Investigator: Cindy M. Hutnik, BSc, PhD, MD, Lawson Health Research Institute
Principal Investigator: Barbara Cvenkel, MD, University Eye Clinic Ljubljana