Ocular Surface Microbiome

NCT ID: NCT02298881

Last Updated: 2021-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2021-05-01

Brief Summary

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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.

Detailed Description

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"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.

Conditions

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Dry Eye Syndromes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Dry eye group

People with dry eye symptoms

No interventions assigned to this group

Non-dry eye group

People with no dry eye symptoms

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Eye Institute (NEI)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Russell Van Gelder

Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Russell N VanGelder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UW Medicine Eye Institute

Locations

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UW Medicine Eye Institute

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Doan T, Akileswaran L, Andersen D, Johnson B, Ko N, Shrestha A, Shestopalov V, Lee CS, Lee AY, Van Gelder RN. Paucibacterial Microbiome and Resident DNA Virome of the Healthy Conjunctiva. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5116-5126. doi: 10.1167/iovs.16-19803.

Reference Type DERIVED
PMID: 27699405 (View on PubMed)

Other Identifiers

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1R01EY022038-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

43018

Identifier Type: -

Identifier Source: org_study_id

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