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

NCT ID: NCT00487643

Last Updated: 2014-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2014-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

James Madison University

OTHER

Sponsor Role: collaborator

Eastern Virginia Medical School

OTHER

Sponsor Role: collaborator

Walter Reed Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Samantha B. Rodgers, MD

Assistant Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kraig S. Bower, MD

Role: PRINCIPAL_INVESTIGATOR

WRAMC

Locations

Walter Reed Army Medical Center

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

Countries

United States

Other Identifiers

WRAMC WU# 07-23021

Identifier Type: -

Identifier Source: org_study_id