- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00554411
Assessing Ocular Surface Changes After Changing Glaucoma Medications
January 26, 2017 updated by: University of Colorado, Denver
Assessing Changes at the Ocular Surface Following the Switch From Xalatan to Travatan Z.
Hypothesis: Changing to Travatan Z therapy increases the tear film break up time of subjects on Xalatan therapy presenting with ocular surface disease.
Study Overview
Status
Completed
Detailed Description
Patients who have been taking Xalatan monotherapy to treat their glaucoma and presenting with ocular surface disease will be advised to switch their medication to Travatan Z. Test results will be recorded at the day that the medication was changed and at follow-up to determine if there is a measurable change in tear film break up, corneal staining and in the Ocular Surface Disease Index.
Study Type
Observational
Enrollment (Actual)
22
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
-
-
Colorado
-
Aurora, Colorado, United States, 80045-0510
- Rocky Mountain Lions Eye Institute
-
-
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
Sampling Method
Non-Probability Sample
Study Population
patients will be selected from the ophthalmology clinic of the principal investigator
Description
Inclusion Criteria:
- on Xalatan monotherapy from 1 to 18 months
- 18 years of age or older
- has been diagnosed with ocular surface disease
Exclusion Criteria:
- special populations such as children, pregnant females, prisoners, etc.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Signs and Symptoms of Ocular Surface Disease
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Malik Y Kahook, M.D., Rocky Mountain Lions Eye Institute
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
November 1, 2007
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
November 2, 2007
First Submitted That Met QC Criteria
November 5, 2007
First Posted (Estimate)
November 6, 2007
Study Record Updates
Last Update Posted (Estimate)
January 27, 2017
Last Update Submitted That Met QC Criteria
January 26, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-0757
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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