- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00273481
Cosopt Versus Xalacom
November 18, 2008 updated by: Pharmaceutical Research Network
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment
33
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
January 6, 2006
First Submitted That Met QC Criteria
January 6, 2006
First Posted (Estimate)
January 9, 2006
Study Record Updates
Last Update Posted (Estimate)
November 19, 2008
Last Update Submitted That Met QC Criteria
November 18, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Enzyme Inhibitors
- Carbonic Anhydrase Inhibitors
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Timolol
- Dorzolamide
- Maleic acid
- Latanoprost
Other Study ID Numbers
- PRN 05-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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