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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01969162
Registration number
NCT01969162
Ethics application status
Date submitted
21/10/2013
Date registered
25/10/2013
Date last updated
21/11/2014
Titles & IDs
Public title
Tear Collection in Adult Volunteers
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Scientific title
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Secondary ID [1]
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195263-008
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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0
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - Tear Sample Collection
All Participants - Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
Treatment: Surgery: Tear Sample Collection
Tear sample collection as per protocol. No investigational drug is administered in this study.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Tear Lipid Composition Profile
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Assessment method [1]
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Basal (non-stimulated) tear samples were collected from one eye for lipid analysis. 13 different lipids classes were detected in individual tear samples. The concentration of each lipid class is reported in picomoles (pmole).
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Timepoint [1]
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Day 1
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Eligibility
Key inclusion criteria
-Adult volunteers without ocular disease.
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Systemic medications that could affect eye health taken within 1 month of enrollment
- Eye infection or inflammation in either eye 3 months prior to screening
- History of herpes in either eye
- Diagnosis of dry eye or meibomian gland dysfunction
- Diagnosis of glaucoma
- Allergic conjunctivitis
- Use of rigid contact lenses within 1 year of screening
- Use of soft contact lenses within 1 week of enrollment.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2013
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Sample size
Target
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- Randwick
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Recruitment postcode(s) [1]
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- Randwick
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This exploratory study will collect tear samples from adult volunteers for determining and
quantifying tear composition profiles. No investigational drug will be administered in this
study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01969162
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Allergan
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Country
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0
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Phone
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Fax
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0
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01969162
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