Analysis of Human Tear Proteins in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00473278
First received: May 11, 2007
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition
Eye Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Human Tear Proteins in Children: A Pilot Study to Describe the Tear Film Proteome of Pediatric Patients Undergoing Ophthalmic Examination.

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Proteome of Human Tears [ Time Frame: Single Exam ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

children less than 18 years of age

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473278

Locations
United States, Colorado
The Childrens Hospital
Denver, Colorado, United States, 80218
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Malik Y. Kahook, MD Rocky Mountain Lions Eye Institute
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00473278     History of Changes
Other Study ID Numbers: 06-1067
Study First Received: May 11, 2007
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
tear protein

Additional relevant MeSH terms:
Eye Diseases

ClinicalTrials.gov processed this record on July 20, 2014