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Ocular Surface Dry Eye Microbiome

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. Identifier: NCT02306668
Recruitment Status : Unknown
Verified December 2014 by Russell Van Gelder, University of Washington.
Recruitment status was:  Recruiting
First Posted : December 3, 2014
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Russell Van Gelder, University of Washington

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
Dry Eyes

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Study Type : Observational
Estimated 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 : February 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Ocular surface discomfort
There are no interventions with this observational study

Primary Outcome Measures :
  1. Identification of bacteria or fungus from conjunctival swab [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
Conjunctival swabs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We will recruit 40 subjects from University of Washington Medicine Eye Institute with ocular surface discomfort consistent with dry eye syndrome, and 40 control subjects

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

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 identifier (NCT number): NCT02306668

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Contact: Sue Rath, COT 206-897-4331

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United States, Washington
UW Medicine Eye Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Sue Rath   
Principal Investigator: Russell Van Gelder, MD, PhD         
Sponsors and Collaborators
University of Washington
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Principal Investigator: Russell Van Gelder, MD, PhD UW Medicine Eye Institute

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Responsible Party: Russell Van Gelder, Professor and Chair, Department of Ophthalmology, University of Washington Identifier: NCT02306668     History of Changes
Other Study ID Numbers: 46093-B
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Russell Van Gelder, University of Washington:
Dry eye

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases