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Cosopt Versus Xalacom

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00273481
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : November 19, 2008
Information provided by:
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.

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : September 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00273481

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Canada, Ontario
Lawson Health Research Insitute
London, Ontario, Canada, N6A 4G5
University Eye Clinic
Ljubljana, Slovenia, A525
Sponsors and Collaborators
Pharmaceutical Research Network
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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
Layout table for additonal information Identifier: NCT00273481    
Other Study ID Numbers: PRN 05-001
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Ophthalmic Solutions
Pharmaceutical Solutions
Carbonic Anhydrase Inhibitors