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Ocular Surface Microbiome

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT02298881
Collaborator
National Institutes of Health (NIH) (NIH), National Eye Institute (NEI) (NIH)
80
Enrollment
1
Location
94
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to collect samples from the surface of eyelids to try to grow and identify bacteria or fungus that might be present, and to try to understand why people have dry eye symptoms.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    "Dry eye" is a very common eye condition, which may or may not be caused by specific microorganisms that live on the surface of the eye. In this study, a combination of tissue culture and molecular biology techniques will be used to identify every microbe (bacteria, fungus, or virus) on the surface of eyes of people with dry eye syndrome, as well as a 'control' group of people who don't have dry eye disease.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Diversity and Dynamic Stability of the Ocular Surface Microbiome
    Study Start Date :
    Jul 1, 2013
    Actual Primary Completion Date :
    May 1, 2021
    Actual Study Completion Date :
    May 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Dry eye group

    People with dry eye symptoms
    Non-dry eye group

    People with no dry eye symptoms

    Outcome Measures

    Primary Outcome Measures

    1. To catalog the bacteria and other micro-organisms that are naturally found on the eye surface. [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Subjects with ocular surface discomfort with an Ocular Surface Disease Index score of greater than 60

    • Subjects with and Ocular Surface disease Index score less than 30

    • Males and females age 18 or older

    Exclusion Criteria:

    • Contact lens wear

    • Use of oral or topical antibiotics in past 6 months

    • Use of prescription eye medication in past 6 months

    • Penetrating ocular or keratoplasty surgery in last 12 months

    • Children under the age of 18

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UW Medicine Eye Institute Seattle Washington United States 98104

    Sponsors and Collaborators

    • University of Washington
    • National Institutes of Health (NIH)
    • National Eye Institute (NEI)

    Investigators

    • Principal Investigator: Russell N VanGelder, MD, PhD, UW Medicine Eye Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Russell Van Gelder, Professor of Ophthalmology, University of Washington
    ClinicalTrials.gov Identifier:
    NCT02298881
    Other Study ID Numbers:
    • 43018
    • 1R01EY022038-01A1
    First Posted:
    Nov 24, 2014
    Last Update Posted:
    May 7, 2021
    Last Verified:
    May 1, 2021
    Keywords provided by Russell Van Gelder, Professor of Ophthalmology, University of Washington
    Dry Eye
    Microbiome
    Additional relevant MeSH terms:
    Dry Eye Syndromes

    Study Results

    No Results Posted as of May 7, 2021