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CompletedNCT02298881Updated May 7, 2021

Ocular Surface Microbiome

An observational study in Dry Eye Syndromes, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-07.

Sponsored by University of Washington · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Dry Eye Syndromes

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Keywords

  • Dry Eye
  • Microbiome
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In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 80 is below the median of 90 across 171 observational studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Dry eye group

    People with dry eye symptoms

  • Non-dry eye group

    People with no dry eye symptoms

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What researchers measure

Primary outcomes

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

    Time frame: 6 months

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Study locations

1 site
  • UW Medicine Eye Institute
    Seattle, Washington 98104, United States
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References and documents

Publications

  • 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. PubMed 27699405 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02298881
Lead sponsor
University of Washington
Collaborators
National Institutes of Health (NIH), National Eye Institute (NEI)
Responsible party
Russell Van Gelder (Professor of Ophthalmology, University of Washington) — Principal investigator
First posted
Nov 24, 2014
Start date
Jul 2013
Primary completion
May 1, 2021
Completion
May 1, 2021
Last update
May 7, 2021

Study contacts

Russell N VanGelder, MD, PhD
principal investigator · UW Medicine Eye Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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