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

NCT00487643 | Completed

• 1 other identifier: WRAMC WU# 07-23021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lacritin

Outcome Measures

Primary Outcomes (1)

• lacritin levels in human tears

  2 minutes after instilling anesthetic eyedrop

Interventions

Tear Collection PROCEDURE

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.

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Military health care beneficiary between the ages of 21-55.

You may qualify if:

• Military health care beneficiary between the ages of 21-55.
• 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.
• 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.
• Ability and willingness to understand and provide informed consent to participate in this study.

You may not qualify if:

• Irritated eye reflected by patient statements or finding of "red" eye.
• Individuals with any infections or inflammatory ocular condition (e.g. have "pink eye" or uveitis).
• 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.
• Individuals who are on any topical eye medications.
• Anyone who reports previous reaction or the possibility of an allergic reaction to 0.5% proparacaine.

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead
• University of Virginia: collaborator
• James Madison University: collaborator
• Eastern Virginia Medical School: collaborator

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Study Officials

• Kraig S. Bower, MD

  WRAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 18, 2007
• Study Start: May 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: March 1, 2014
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

US (1)