Status:
COMPLETED
Cosopt Versus Xalacom
Lead Sponsor:
Pharmaceutical Research Network
Conditions:
Open-Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00273481
Start Date
September 1 2005
End Date
April 1 2007
Last Update
November 19 2008
Active Locations (2)
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1
Lawson Health Research Insitute
London, Ontario, Canada, N6A 4G5
2
University Eye Clinic
Ljubljana, Slovenia, A525