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Completed

NCT Number: NCT00731484

Validation of TearLab Osmometer - Human Factor Usability Report

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gordon Binder Weiss Vision Institute, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

TearLab Corporation

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 11, 2008
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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