Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
University of Virginia
James Madison University
Eastern Virginia Medical School
Information provided by (Responsible Party):
Samantha B. Rodgers, MD, Fort Belvoir Community Hospital
ClinicalTrials.gov Identifier:
NCT00487643
First received: June 15, 2007
Last updated: July 10, 2014
Last verified: July 2014
  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:
  • lacritin levels in human tears [ Time Frame: 2 minutes after instilling anesthetic eyedrop ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2008
Study Completion Date: March 2014
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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Samantha B. Rodgers, MD, Assistant Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir, Fort Belvoir Community Hospital
ClinicalTrials.gov Identifier: NCT00487643     History of Changes
Other Study ID Numbers: WRAMC WU# 07-23021
Study First Received: June 15, 2007
Last Updated: July 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
Lacritin

ClinicalTrials.gov processed this record on November 27, 2014