Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
Completed
NCT Number: NCT00487643
Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay
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.
Completed
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Notify MeKey information
Conditions
Age range
21 year–55 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Tear Collection
ProcedureThe 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.
Primary outcomes
-
lacritin levels in human tears
Time frame: 2 minutes after instilling anesthetic eyedrop
Sponsors and collaborators
Lead sponsor
Walter Reed Army Medical Center
Fed
Collaborators
- Eastern Virginia Medical School
- James Madison University
- University of Virginia
Registry information
Important dates
- Study start
- 2008
- Primary completion
- 2010
- Study completion
- 2014
- First posted
- Jun 18, 2007
- Registry last updated
- Jul 11, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.