Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00487643
Enrollment
100
Registered
2007-06-18
Start date
2008-05-31
Completion date
2014-03-31
Last updated
2014-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tear Protein Lacritin in Human Tears

Keywords

Lacritin

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.

Interventions

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.

Sponsors

University of Virginia
CollaboratorOTHER
James Madison University
CollaboratorOTHER
Eastern Virginia Medical School
CollaboratorOTHER
Walter Reed Army Medical Center
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
lacritin levels in human tears2 minutes after instilling anesthetic eyedrop

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026