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NCT02306668 Clinical Trial

Ocular Surface Dry Eye Microbiome

Dry Eyes Clinical Trial

Official title:
Microbiome Analysis of the Ocular Surface in Dry Eye Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02306668
Other study ID # 46093-B
Secondary ID
Status Recruiting
Phase N/A
First received December 1, 2014
Last updated December 2, 2014
Start date February 2014
Est. completion date December 2016

Study information
Verified date December 2014
Source University of Washington
Contact Sue Rath, COT
Phone 206-897-4331
Email raths@uw.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States UW Medicine Eye Institute Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of bacteria or fungus from conjunctival swab 1 month No
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