Diagnostic Evaluation of the Tear Film

NCT ID: NCT00761917

Last Updated: 2015-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

229 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-11-30

Brief Summary

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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

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Conditions

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Dry Eye Syndromes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1: Normal

Subjects without dry eye symptoms based on questionnaire.

Tear Film Analyzer

Intervention Type DEVICE

tear film images

2: Dry Eye

Subjects with dry eye symptoms based on questionnaire.

Tear Film Analyzer

Intervention Type DEVICE

tear film images

Interventions

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Tear Film Analyzer

tear film images

Intervention Type DEVICE

Other Intervention Names

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ocular surface interferometry

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TearScience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christy Stevens, OD

Role: STUDY_DIRECTOR

Kolis Scientific

Locations

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Fayetteville, Arkansas, United States

Site Status

Morrow, Georgia, United States

Site Status

Oak Lawn, Illinois, United States

Site Status

Edgewood, Kentucky, United States

Site Status

Bloomington, Minnesota, United States

Site Status

Chesterfield, Missouri, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Henderson, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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KS010

Identifier Type: -

Identifier Source: org_study_id

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