Diagnostic Evaluation of the Tear Film

March 30, 2015 updated by: TearScience, Inc.

Analysis of the Tear Film Lipid Layer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

229

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States
    • Georgia
      • Morrow, Georgia, United States
    • Illinois
      • Oak Lawn, Illinois, United States
    • Kentucky
      • Edgewood, Kentucky, United States
    • Minnesota
      • Bloomington, Minnesota, United States
    • Missouri
      • Chesterfield, Missouri, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Henderson, North Carolina, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects undergoing routine eye examination in ophthalmic practices

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Dry Eye Symptoms
Time Frame: upon enrollment
upon enrollment
Tear Film Break-Up Time
Time Frame: upon enrollment
upon enrollment
Corneal and Conjunctival Staining
Time Frame: upon enrollment
upon enrollment
Meibomian Gland Assessment
Time Frame: upon enrollment
upon enrollment
Schirmer Test
Time Frame: upon enrollment
upon enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TearScience, Inc.

Investigators

  • Study Director: Christy Stevens, OD, Kolis Scientific

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Syndromes

Clinical Trials on Tear Film Analyzer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe