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Ocular Surface Dry Eye Microbiome

Sponsor
University of Washington (Other)
Overall Status
Unknown status
CT.gov ID
NCT02306668
Collaborator
(none)
80
Enrollment
1
Location
34
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators seek to characterize the identity of all microorganisms residing on the eye's surface (conjunctiva) in healthy eyes and those with dry eye syndrome, using a combination of analyses. Dry eye disease is thought to have an inflammatory basis and in the vast majority of cases the cause of the chronic inflammatory condition is unknown.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Microbiome Analysis of the Ocular Surface in Dry Eye Disease
    Study Start Date :
    Feb 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2016
    Anticipated Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Ocular surface discomfort

    There are no interventions with this observational study

    Outcome Measures

    Primary Outcome Measures

    1. Identification of bacteria or fungus from conjunctival swab [1 month]

    Eligibility Criteria

    Criteria

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

    • dry eye syndrome with OSDI score greater than 60

    • control group with OSDI score less than 30

    Exclusion Criteria:

    • recent history of contact lens wear

    • use of topical antibiotics or prescription eye medication in past 6 months

    • penetrating ocular surgery in the last 12 months

    • age less than 18 years

    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

    Investigators

    • Principal Investigator: Russell Van Gelder, MD, PhD, UW Medicine Eye Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Russell Van Gelder, Professor and Chair, Department of Ophthalmology, University of Washington
    ClinicalTrials.gov Identifier:
    NCT02306668
    Other Study ID Numbers:
    • 46093-B
    First Posted:
    Dec 3, 2014
    Last Update Posted:
    Dec 3, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Russell Van Gelder, Professor and Chair, Department of Ophthalmology, University of Washington
    Dry eye
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca

    Study Results

    No Results Posted as of Dec 3, 2014