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Validation of TearLab Osmometer - Human Factor Usability Report

This study has been completed.
Information provided by (Responsible Party):
TearLab Corporation Identifier:
First received: August 7, 2008
Last updated: March 14, 2016
Last verified: February 2016
The objective of this study is to validate the performance of the OcuSense TearLab™ osmolarity test when performed in physician office laboratories (POL) by health care professionals using human tear fluid collected from volunteer subjects and contrived tear samples.

Dry Eye Syndromes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Validation of TearLab Osmometer - Human Factor Usability Report

Resource links provided by NLM:

Further study details as provided by TearLab Corporation:

Primary Outcome Measures:
  • Tear Osmolarity in Human Measured by TearLab System [ Time Frame: Single visit, at time of tear osmolarity testing. ]
    Tear osmolarity was measured with a laboratory-on-a-chip, which simultaneously collects and analyzes the electrical impedance of a 50 nL tear sample from the inferior lateral meniscus (TearLab Osmolarity System). The results are reported in mOsm/L. The trial was not set up to evaluate diagnostic performance, as no gold-standard method was used to establish dry eye status, but rather, to determine whether the TearLab could measure tear osmolarity in human subjects.

Enrollment: 233
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Volunteer Patients/Subjects
These subjects should present the general population.

Detailed Description:
To validate the performance and usability of the TearLab osmometer, specifically human factor usability, when used in the hands of intended users, i.e. ophthalmology and optometry clinics. This testing is required to insure that the Osmolarity System meets the Product Requirements and for completion of the Technical File, Design History File and FDA 510(k) Submission.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Ophthalmic and optometric clinics.

Inclusion Criteria:

  • Healthy volunteers representing the general population (a minimum of 120 subjects representing 50% of the total study population,
  • Otherwise healthy volunteers previously-diagnosed with moderate or severe chronic dry eye and/or Sjogrens syndrome and/or designated as dry eye disease subjects by the OSDI questionnaire (a minimum of 40 subjects representing 50% of the total study population),
  • Men or women,
  • Adult 18 years or older,
  • Contact lens wearers may participate,
  • Patients having undergone refractive surgery may participate,
  • Patients having undergone cataract surgery may participate

Exclusion Criteria:

  • Eye pathology other than previously-diagnosed moderate or severe chronic dry eye and/or Sjogrens syndrome, Use of topical medication within the last 24 hours,
  • Eye drop usage within the last 2 hours,
  • Ocular surface staining within the last 2 hours,
  • Other invasive ocular diagnostic testing within the last 2 hours,
  • Crying within the last 30 minutes,
  • Eye makeup present on the eye lid within 10 minutes of tear collection,
  • Examination by slit lamp within 10 minutes of tear collection.
  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 identifier: NCT00731484

United States, California
Gordon Binder Weiss Vision Institute
San Diego, California, United States, 92130
United States, Kentucky
Kentucky Lion Eye Center, University of Louisville
Louisville, Kentucky, United States, 40202
United States, Ohio
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
TearLab Corporation
Study Chair: Michael A Lemp, MD Clinical Professor of Ophthalmology, Georgetown University
  More Information

Responsible Party: TearLab Corporation Identifier: NCT00731484     History of Changes
Other Study ID Numbers: TP00004
Study First Received: August 7, 2008
Results First Received: April 6, 2011
Last Updated: March 14, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data was used in the FDA 510(K) submission.

Keywords provided by TearLab Corporation:
Dry Eye Disease
Tear Osmolarity
Tear Osmolality

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctival Diseases
Corneal Diseases processed this record on August 23, 2017