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Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay

NCT00487643 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2014-07-11

No results posted yet for this study

Summary

Purpose: to build a library of normal tear lacritin values by collecting tears from normal adult human subjects and to develop a non-invasive clinical assay for lacritin. Such an assay will provide more sensitive indicators of eye disease for clinicians and determine if a particular therapy, such as recombinant lacritin drops, is of benefit.

Conditions

  • Tear Protein Lacritin in Human Tears

Interventions

PROCEDURE

Tear Collection

The tear sample will be collected from the left eye of each subject. Subjects wearing contact lenses will be instructed to remove their lenses and wait at least 5 minutes before proceeding with the tear collection procedure. The patient will then be instructed to sit with eyes gently closed for two minutes after instilling one (1) drop of 0.5% proparacaine on the cornea and conjunctiva. Tear collection was accomplished by using a polyester fiber rod wick. This wick will be placed in contact with the tear fluid at the lower cul-de-sac for a minimum time to obtain fluid without irritating the subject's eye approx. for 3 to 5 minutes.

Sponsors & Collaborators

  • University of Virginia

    collaborator OTHER

  • James Madison University

    collaborator OTHER

  • Eastern Virginia Medical School

    collaborator OTHER

  • Walter Reed Army Medical Center

    lead FED

Principal Investigators

  • Kraig S. Bower, MD · WRAMC

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-10-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00487643 on ClinicalTrials.gov