- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00273429
Cosopt Versus Xalatan
January 8, 2007 updated by: Pharmaceutical Research Network
To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
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.
Study Locations
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Florida
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Lakeland, Florida, United States, 33805
- Central Florida Eye Associates
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Illinois
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Bourbonnais, Illinois, United States, 60914
- Midwest Eye Center SC
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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, pigmentary, or exfoliation glaucoma, or ocular hypertenstion
- intraocular pressure should be 22 to 30 mm Hg inclusive on timolol BID at the 08:00 H
- ETDRS visual acuity must be 1.0 or better in both eyes
Exclusion Criteria:
- any contraindications to study medications
- any anticipated change in systemic hypertensive therapy during the trial
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: Jay Mulaney, MD, Central Florida Eye Associates
- Principal Investigator: Sriram Sonty, MD, FACS, Midwest Eye Center SC
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
April 1, 2005
Study Completion
December 1, 2005
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)
January 9, 2007
Last Update Submitted That Met QC Criteria
January 8, 2007
Last Verified
January 1, 2007
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 04-015
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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