NCT02306668

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

2.8 years

First QC Date

December 1, 2014

Last Update Submit

December 2, 2014

Conditions

Dry Eyes

Keywords

Dry eye

Outcome Measures

Primary Outcomes (1)

  • Identification of bacteria or fungus from conjunctival swab

    1 month

Study Arms (1)

Ocular surface discomfort

There are no interventions with this observational study

Eligibility Criteria

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

You may qualify if:

  • dry eye syndrome with OSDI score greater than 60
  • control group with OSDI score less than 30

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Medicine Eye Institute

Seattle, Washington, 98104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Conjunctival swabs

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Russell Van Gelder, MD, PhD

    UW Medicine Eye Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sue Rath, COT

CONTACT

206-897-4331raths@uw.edu

Study Design

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

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

US(1)