Cosopt Versus Xalacom
Information source: Pharmaceutical Research Network
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Open-Angle Glaucoma; Ocular Hypertension
Intervention: 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 (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pharmaceutical Research Network Official(s) and/or principal investigator(s):
William C. Stewart, MD, Study Director, Affiliation: Pharmaceutical Research Network, LLC
Cindy M. Hutnik, BSc, PhD, MD, Principal Investigator, Affiliation: Lawson Health Research Institute
Barbara Cvenkel, MD, Principal Investigator, Affiliation: University Eye Clinic Ljubljana
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University Eye Clinic, Ljubljana A525, Slovenia
Lawson Health Research Insitute, London, Ontario N6A 4G5, Canada
Additional Information
Starting date: September 2005
Last updated: March 30, 2007
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