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CompletedNCT00487643Updated Jul 11, 2014

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

An observational study in Tear Protein Lacritin in Human Tears, sponsored by Walter Reed Army Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-11.

Sponsored by Walter Reed Army Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
21 Years to 55 Years
Sex
All
01

Study 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.

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Conditions studied

  • Tear Protein Lacritin in Human Tears

Keywords

  • Lacritin
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In context

Lead sponsor

Walter Reed Army Medical Center is the lead sponsor of 45 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)

Interventions

  • ProcedureTear 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.

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What researchers measure

Primary outcomes

  1. lacritin levels in human tears

    Time frame: 2 minutes after instilling anesthetic eyedrop

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Study locations

1 site
  • Walter Reed Army Medical Center
    Washington, District of Columbia 20307, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00487643
Lead sponsor
Walter Reed Army Medical Center
Collaborators
University of Virginia, James Madison University, Eastern Virginia Medical School
Responsible party
Samantha B. Rodgers, MD (Assistant Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir, Fort Belvoir Community Hospital) — Principal investigator
First posted
Jun 18, 2007
Start date
May 2008
Primary completion
Oct 2010
Completion
Mar 2014
Last update
Jul 11, 2014

Study contacts

Kraig S. Bower, MD
principal investigator · WRAMC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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