CClinicalTrials.gg
CompletedNCT00761917Updated Mar 31, 2015

Diagnostic Evaluation of the Tear Film

An observational study in Dry Eye Syndromes, sponsored by TearScience, Inc.. Completed at 8 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-31.

Sponsored by TearScience, Inc. · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
229
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dry Eye Syndromes

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03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 229 is above the median of 90 across 171 observational studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

TearScience, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
229 participants (actual)

Groups and cohorts

  • 1: Normal

    Subjects without dry eye symptoms based on questionnaire.

    Device: Tear Film Analyzer

  • 2: Dry Eye

    Subjects with dry eye symptoms based on questionnaire.

    Device: Tear Film Analyzer

Interventions

  • DeviceTear Film Analyzer

    tear film images

    Also known as: ocular surface interferometry

06

What researchers measure

Primary outcomes

  1. Tear film analysis of lipid layer quality

    Time frame: upon enrollment

Secondary outcomes

  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

07

Study locations

8 sites
  • Fayetteville, Arkansas, United States
  • Morrow, Georgia, United States
  • Oak Lawn, Illinois, United States
  • Edgewood, Kentucky, United States
  • Bloomington, Minnesota, United States
  • Chesterfield, Missouri, United States
  • Charlotte, North Carolina, United States
  • Henderson, North Carolina, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00761917
Lead sponsor
TearScience, Inc.
Responsible party
Sponsor
First posted
Sep 30, 2008
Start date
Jun 2008
Primary completion
Oct 2008
Completion
Nov 2008
Last update
Mar 31, 2015

Study contacts

Christy Stevens, OD
study director · Kolis Scientific

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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