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Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay
This study is currently recruiting participants.
Verified by Walter Reed Army Medical Center, March 2008
Sponsors and Collaborators: Walter Reed Army Medical Center
University of Virginia
James Madison University
Eastern Virginia Medical School
Information provided by: Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00487643
  Purpose

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.


Condition Intervention
Tear Protein Lacritin in Human Tears
Procedure: Tear Collection

U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay
  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Military health care beneficiary between the ages of 21-55.
  2. Male or female, of any race, and at least 21 years old and not older than 55 years old at the time of tear collection.
  3. Appropriately aged individuals who report that their eyes are "normal" and who have no active eye illness as determined by principal investigator or sub-investigator.
  4. Ability and willingness to understand and provide informed consent to participate in this study.

Exclusion Criteria:

  1. Irritated eye reflected by patient statements or finding of "red" eye.
  2. Individuals with any infections or inflammatory ocular condition (e.g. have "pink eye" or uveitis).
  3. Individuals diagnosed with dry eye or other ocular surface condition, including but not restricted to neurotrophic keratitis, anterior basement membrane dystrophy, and recurrent corneal erosions.
  4. Individuals who are on any topical eye medications.
  5. Anyone who reports previous reaction or the possibility of an allergic reaction to 0.5% proparacaine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487643

Locations
United States, District of Columbia
Walter Reed Army Medical Center Recruiting
WASHINGTON, District of Columbia, United States, 20307
Contact: Kraig s. Bower, MD     202-782-0202     kraig.bower@na.amedd.army.mil    
Principal Investigator: Kraig S. Bower, MD            
Sponsors and Collaborators
Walter Reed Army Medical Center
University of Virginia
James Madison University
Eastern Virginia Medical School
Investigators
Principal Investigator: Kraig S. Bower, MD WRAMC
  More Information

Responsible Party: Walter Reed Army Medical Center ( Kraig S. Bower, Study Principal Investigator )
Study ID Numbers: WRAMC WU# 07-23021
Study First Received: June 15, 2007
Last Updated: March 31, 2008
ClinicalTrials.gov Identifier: NCT00487643  
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
Lacritin

Study placed in the following topic categories:
Lacerations

ClinicalTrials.gov processed this record on January 16, 2009