Diagnostic Evaluation of the Tear Film

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TearScience, Inc.
ClinicalTrials.gov Identifier:
NCT00761917
First received: September 26, 2008
Last updated: March 30, 2015
Last verified: March 2015
  Purpose

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 Intervention
Dry Eye Syndromes
Device: Tear Film Analyzer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Analysis of the Tear Film Lipid Layer

Resource links provided by NLM:


Further study details as provided by TearScience, Inc.:

Primary Outcome Measures:
  • Tear film analysis of lipid layer quality [ Time Frame: upon enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dry Eye Symptoms [ Time Frame: upon enrollment ] [ Designated as safety issue: No ]
  • Tear Film Break-Up Time [ Time Frame: upon enrollment ] [ Designated as safety issue: No ]
  • Corneal and Conjunctival Staining [ Time Frame: upon enrollment ] [ Designated as safety issue: No ]
  • Meibomian Gland Assessment [ Time Frame: upon enrollment ] [ Designated as safety issue: No ]
  • Schirmer Test [ Time Frame: upon enrollment ] [ Designated as safety issue: No ]

Enrollment: 229
Study Start Date: June 2008
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects undergoing routine eye examination in ophthalmic practices

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761917

Locations
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.
Investigators
Study Director: Christy Stevens, OD Kolis Scientific
  More Information

No publications provided

Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT00761917     History of Changes
Other Study ID Numbers: KS010
Study First Received: September 26, 2008
Last Updated: March 30, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 26, 2015