Tear Protein Lacritin in Human TearsNCT00487643
Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay
An observational study of Tear Protein Lacritin in Human Tears, run by Walter Reed Army Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tear Protein Lacritin in Human Tears
- What is being tested?
- Tear Collection
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Military health care beneficiary between the ages of 21-55.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
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.
- Conditions
- Tear Protein Lacritin in Human Tears
- Being tested
- Tear Collection
- Keywords
- Lacritin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tear CollectionProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
lacritin levels in human tears
Measured: 2 minutes after instilling anesthetic eyedrop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startMay 2008
- Primary completionOct 2010
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tear Protein Lacritin in Human TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Virginia, James Madison University, Eastern Virginia Medical School
- Responsible party
- Principal investigator, Samantha B. Rodgers, MD, Fort Belvoir Community Hospital
- Investigators
- Kraig S. Bower, MD, Principal investigator, WRAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487643
- Sponsor's protocol ID
- WRAMC WU# 07-23021
- Status last verified
- Jul 2014
- First submitted
- 15 Jun 2007
- Last updated
- 11 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay
- ClinicalTrials.gov ID
- NCT00487643
- Acronym / sponsor ID
- WRAMC WU# 07-23021
- Conditions
- Tear Protein Lacritin in Human Tears
- Keywords
- Lacritin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Collaborators
- University of Virginia, James Madison University, Eastern Virginia Medical School
- Study start
- May 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Military health care beneficiary between the ages of 21-55.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tear CollectionThe 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. | Procedure or surgery | – |
Primary outcome
lacritin levels in human tears
Time frame: 2 minutes after instilling anesthetic eyedrop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kraig S. Bower, MD principal investigator
WRAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tear Protein Lacritin in Human Tears, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lacritin levels in human tears (time frame: 2 minutes after instilling anesthetic eyedrop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.