Ocular Surface Microbiome | NCT02298881

Studies
Ocular Surface Microbiome

NCT02298881

Sponsor

University of Washington

Status

Completed

Last Update Posted

May 7, 2021Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Dry Eye Syndromes

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01EY022038-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

May 1, 2021Actual

Completion Date

May 1, 2021Actual

First Submitted Date

Nov 18, 2014

First Submission Date that Met QC Criteria

Nov 19, 2014

First Posted Date

Nov 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2021

Last Update Posted Date

May 7, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Russell Van Gelder, Professor of Ophthalmology, University of WashingtonPrincipal Investigator

Lead Sponsor

University of WashingtonOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH
National Eye Institute (NEI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dry eye group		People with dry eye symptoms
Non-dry eye group		People with no dry eye symptoms

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To catalog the bacteria and other micro-organisms that are naturally found on the eye surface.		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Russell N VanGelder, MD, PhD	UW Medicine Eye Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UW Medicine Eye Institute		Seattle	Washington	98104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27699405	Derived	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.

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases