- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00473278
Analysis of Human Tear Proteins in Children
January 29, 2013 updated by: University of Colorado, Denver
Analysis of Human Tear Proteins in Children: A Pilot Study to Describe the Tear Film Proteome of Pediatric 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, and any unique aspects of tears in children.
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
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2
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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Denver, Colorado, United States, 80218
- The Childrens Hospital
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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
No older than 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
children less than 18 years of age
Description
Inclusion Criteria:
- Less than 18 years of age
- A parent or legal guardian provide written informed consent to participate
- Able to cooperate with tear sample collection, or a previously planned sedation for other medical purposes
Exclusion Criteria:
- Age greater than or equal to 18 years
- Patients' parents or legal guardians who refuse to sign study 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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proteome of Human Tears
Time Frame: Single Exam
|
Single Exam
|
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
January 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
May 11, 2007
First Submitted That Met QC Criteria
May 11, 2007
First Posted (Estimate)
May 15, 2007
Study Record Updates
Last Update Posted (Estimate)
January 30, 2013
Last Update Submitted That Met QC Criteria
January 29, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
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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