NCT02298881

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

7.8 years

First QC Date

November 18, 2014

Last Update Submit

May 4, 2021

Conditions

Dry Eye Syndromes

Keywords

Dry EyeMicrobiome

Outcome Measures

Primary Outcomes (1)

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

    6 months

Study Arms (2)

Dry eye group

People with dry eye symptoms

Non-dry eye group

People with no dry eye symptoms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Medicine Eye Institute

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • 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.

    PMID: 27699405DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Swab or scrapings of the cornea

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Russell N VanGelder, MD, PhD

    UW Medicine Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 24, 2014

Study Start

July 1, 2013

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

May 7, 2021

Record last verified: 2021-05

Locations

US(1)