Ocular Surface Microbiome

May 4, 2021 updated by: Russell Van Gelder, University of Washington

Diversity and Dynamic Stability of the Ocular Surface Microbiome

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • UW Medicine Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients from the investigators' practices at the University of Washington Eye Institute

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Dry eye group
People with dry eye symptoms
Non-dry eye group
People with no dry eye symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To catalog the bacteria and other micro-organisms that are naturally found on the eye surface.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Eye Institute (NEI)
National Institutes of Health (NIH)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43018
  • 1R01EY022038-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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