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Tear Collection in Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01969162
Recruitment Status : Completed
First Posted : October 25, 2013
Results First Posted : November 21, 2014
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease Intervention/treatment
Healthy Volunteers Procedure: Tear Sample Collection

Study Design
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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Groups and Cohorts
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Group/Cohort Intervention/treatment
All Participants
Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
 Procedure: Tear Sample Collection
Tear sample collection as per protocol. No investigational drug is administered in this study.


Outcome Measures
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Primary Outcome Measures :
  1. Tear Lipid Composition Profile [ Time Frame: Day 1 ]
    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).


Biospecimen Retention:   Samples With DNA
Tears

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult volunteers without ocular disease.
Criteria

Inclusion Criteria:

-Adult volunteers without ocular disease.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969162


Locations
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Australia, New South Wales
Randwick, New South Wales, Australia
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01969162    
Other Study ID Numbers: 195263-008
First Posted: October 25, 2013    Key Record Dates
Results First Posted: November 21, 2014
Last Update Posted: November 21, 2014
Last Verified: November 2014