Pilot Study of Human Tear Proteins

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00453258
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Duration (Months): 55
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Disease	Other: Eye Examination

Study Design

• Study Type: Observational
• Actual Enrollment: 63 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Analysis of Human Tear Proteins: A Pilot Study to Describe the Tear Film Proteome of Patients Undergoing Ophthalmic Examination.
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Study Subject Subjects receiving eye examination	Other: Eye Examination; Subjects receiving eye examination

Outcome Measures

Primary Outcome Measures

1. Plan Prospective Research [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rocky Mountain Lions Eye Institute	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Malik Y. Kahook, MD, Rocky Mountain Lions Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00453258
• Other Study ID Numbers: 06-0862
• First Posted: Mar 28, 2007
• Last Update Posted: Jan 17, 2013
• Last Verified: Oct 1, 2012

• Keywords provided by University of Colorado, Denver: ocular proteomics; eye disease; proteomics
• Additional relevant MeSH terms: Eye Diseases

Study Results

No Results Posted as of Jan 17, 2013