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Diagnostic Evaluation of the Tear Film

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00761917
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : March 31, 2015
Information provided by (Responsible Party):

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
Dry Eye Syndromes 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 : June 2008
Primary Completion Date : October 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Tears
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1: Normal
Subjects without dry eye symptoms based on questionnaire.
Device: Tear Film Analyzer
tear film images
Other Name: ocular surface interferometry
2: Dry Eye
Subjects with dry eye symptoms based on questionnaire.
Device: Tear Film Analyzer
tear film images
Other Name: ocular surface interferometry

Outcome Measures

Primary Outcome Measures :
  1. Tear film analysis of lipid layer quality [ Time Frame: upon enrollment ]

Secondary Outcome Measures :
  1. Dry Eye Symptoms [ Time Frame: upon enrollment ]
  2. Tear Film Break-Up Time [ Time Frame: upon enrollment ]
  3. Corneal and Conjunctival Staining [ Time Frame: upon enrollment ]
  4. Meibomian Gland Assessment [ Time Frame: upon enrollment ]
  5. Schirmer Test [ Time Frame: upon enrollment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing routine eye examination in ophthalmic practices

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761917

United States, Arkansas
Fayetteville, Arkansas, United States
United States, Georgia
Morrow, Georgia, United States
United States, Illinois
Oak Lawn, Illinois, United States
United States, Kentucky
Edgewood, Kentucky, United States
United States, Minnesota
Bloomington, Minnesota, United States
United States, Missouri
Chesterfield, Missouri, United States
United States, North Carolina
Charlotte, North Carolina, United States
Henderson, North Carolina, United States
Sponsors and Collaborators
TearScience, Inc.
Study Director: Christy Stevens, OD Kolis Scientific
More Information

Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT00761917     History of Changes
Other Study ID Numbers: KS010
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctival Diseases
Corneal Diseases