Diagnostic Evaluation of the Tear Film | NCT00761917

Studies
Diagnostic Evaluation of the Tear Film

NCT00761917

Sponsor

TearScience, Inc.

Status

Completed

Last Update Posted

Mar 31, 2015Estimated

Enrollment

229Actual

Phase

Not provided

Conditions

Dry Eye Syndromes

Interventions

Tear Film Analyzer

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

Mar 2015

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

Jun 2008

Primary Completion Date

Oct 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Sep 26, 2008

First Submission Date that Met QC Criteria

Sep 26, 2008

First Posted Date

Sep 30, 2008Estimated

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

Mar 30, 2015

Last Update Posted Date

Mar 31, 2015Estimated

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 objectives of this study are to assess for a difference between normal and dry eye subjects in tear film quality using a diagnostic interferometry device and to determine whether there are associations between tear film quality and dry eye symptoms and signs.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

229Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1: Normal		Subjects without dry eye symptoms based on questionnaire.	Device: Tear Film Analyzer
2: Dry Eye		Subjects with dry eye symptoms based on questionnaire.	Device: Tear Film Analyzer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tear Film Analyzer	Device	tear film images	1: Normal 2: Dry Eye

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tear film analysis of lipid layer quality		upon enrollment

Secondary Outcomes

Measure	Description	Time Frame
Dry Eye Symptoms		upon enrollment
Tear Film Break-Up Time		upon enrollment
Corneal and Conjunctival Staining

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults 18 year of age or older
Willing and able to comply with study exam procedure

Exclusion Criteria:

Eyelid abnormality or ocular surface condition affecting ability to visualize tear film
Women who are pregnant or nursing
Any of the following conditions within specified timeframe prior to study participation:
1. Instillation of eye drops
2. Contact lens wear
3. Use of oil-based facial cosmetics
4. Swimming in chlorinated pool
5. Eye examination procedures that may affect the tear film
6. Participation in another ophthalmic clinical trial

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

Subjects undergoing routine eye examination in ophthalmic practices

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christy Stevens, OD	Kolis Scientific	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Fayetteville	Arkansas		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