Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay
This study is ongoing, but not recruiting participants.
Sponsor:
Walter Reed Army Medical Center
Collaborators:
University of Virginia
James Madison University
Eastern Virginia Medical School
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00487643
First received: June 15, 2007
Last updated: January 7, 2013
Last verified: January 2013
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay |
Further study details as provided by Walter Reed Army Medical Center:
Primary Outcome Measures:
- Normal lacritin levels in human tears [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Military health care beneficiary between the ages of 21-55.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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 | |
| Washington, District of Columbia, United States, 20307 | |
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
No publications provided
| Responsible Party: | Kraig S. Bower, Study Principal Investigator, Walter Reed Army Medical Center |
| ClinicalTrials.gov Identifier: | NCT00487643 History of Changes |
| Other Study ID Numbers: | WRAMC WU# 07-23021 |
| Study First Received: | June 15, 2007 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Walter Reed Army Medical Center:
|
Lacritin |
Additional relevant MeSH terms:
|
Lacerations Rupture Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013