Ocular Surface Dry Eye Microbiome | NCT02306668

Studies
Ocular Surface Dry Eye Microbiome

NCT02306668

Sponsor

University of Washington

Status

Unknown status

Last Update Posted

Dec 3, 2014Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Dry Eyes

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

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Dec 1, 2014

First Submission Date that Met QC Criteria

Dec 2, 2014

First Posted Date

Dec 3, 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

Dec 2, 2014

Last Update Posted Date

Dec 3, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Russell Van Gelder, Professor and Chair, Department of Ophthalmology, University of WashingtonPrincipal Investigator

Lead Sponsor

University of WashingtonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 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.

Detailed Description

Not provided

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ocular surface discomfort		There are no interventions with this observational study

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identification of bacteria or fungus from conjunctival swab		1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sue Rath, COT	Contact	206-897-4331		raths@uw.edu

Overall Officials

Name	Affiliation	Role
Russell Van Gelder, MD, PhD	UW Medicine Eye Institute	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided