- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00453258
Pilot Study of Human Tear Proteins
January 15, 2013 updated by: University of Colorado, Denver
Analysis of Human Tear Proteins: A Pilot Study to Describe the Tear Film Proteome of Patients Undergoing Ophthalmic Examination.
The significance of our study is in the importance of understanding the quality and quantity of proteins in the human tear film from diseased and non-diseased patients.
This pilot study will provide data to plan prospective research to better delineate the utility of tear proteins in diagnosing and following disease status in a non-invasive fashion.
Study Overview
Study Type
Observational
Enrollment (Actual)
63
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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Colorado
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Aurora, Colorado, United States, 80045
- Rocky Mountain Lions Eye Institute
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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
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects receiving eye examination
Description
Inclusion Criteria:
- 18 years of age and older
- able to cooperate with tear sample collection
- provide written informed consent
Exclusion Criteria:
- special populations (children, pregnant or lactating females, prisoners, etc)
- refusal to sign sudy consent
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Study Subject
Subjects receiving eye examination
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Subjects receiving eye examination
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plan Prospective Research
Time Frame: Throughout study participation
|
Pilot study will provide data to plan prospective research to better delineate the utility of tear proteins in diagnosing and following disease status in a non-invasive fashion.
|
Throughout study participation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Malik Y. Kahook, MD, 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
February 1, 2007
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
March 26, 2007
First Submitted That Met QC Criteria
March 27, 2007
First Posted (Estimate)
March 28, 2007
Study Record Updates
Last Update Posted (Estimate)
January 17, 2013
Last Update Submitted That Met QC Criteria
January 15, 2013
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-0862
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.