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

Completed

• Conditions: Tear Protein Lacritin in Human Tears

• Registration Number: NCT00487643
• Lead Sponsor: Walter Reed Army Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-15
• Study First Submitted QC: 2007-06-15
• Study First Posted: 2007-06-18
• Study Start: 2008-05
• Primary Completion: 2010-10
• Study Completion: 2014-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lacritin levels in human tears	2 minutes after instilling anesthetic eyedrop

Trial Locations

Locations (1)

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States