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Diagnostic Evaluation of the Tear Film

Sponsor
TearScience, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00761917
Collaborator
(none)
229
Enrollment
8
Locations
5
Duration (Months)
28.6
Patients Per Site
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Tear Film Analyzer

Study Design

Study Type:
Observational
Actual Enrollment :
229 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Analysis of the Tear Film Lipid Layer
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
1: Normal

Subjects without dry eye symptoms based on questionnaire.

Device: Tear Film Analyzer
tear film images
Other Names:
  • ocular surface interferometry

    		•
    2: Dry Eye

    Subjects with dry eye symptoms based on questionnaire.

    Device: Tear Film Analyzer
    tear film images
    Other Names:
  • ocular surface interferometry

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tear film analysis of lipid layer quality [upon enrollment]

    Secondary Outcome Measures

    1. Dry Eye Symptoms [upon enrollment]

    2. Tear Film Break-Up Time [upon enrollment]

    3. Corneal and Conjunctival Staining [upon enrollment]

    4. Meibomian Gland Assessment [upon enrollment]

    5. Schirmer Test [upon enrollment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fayetteville Arkansas United States
    2 Morrow Georgia United States
    3 Oak Lawn Illinois United States
    4 Edgewood Kentucky United States
    5 Bloomington Minnesota United States
    6 Chesterfield Missouri United States
    7 Charlotte North Carolina United States
    8 Henderson North Carolina United States

    Sponsors and Collaborators

    • TearScience, Inc.

    Investigators

    • Study Director: Christy Stevens, OD, Kolis Scientific

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TearScience, Inc.
    ClinicalTrials.gov Identifier:
    NCT00761917
    Other Study ID Numbers:
    • KS010
    First Posted:
    Sep 30, 2008
    Last Update Posted:
    Mar 31, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:
    Dry Eye Syndromes

    Study Results

    No Results Posted as of Mar 31, 2015