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COMPLETEDNCT00731484

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 ...

Lead sponsor: TearLab Corporation•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

TearLab Corporation

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 12, 2016Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment233

Start dateJul 2008

Last updatedApr 12, 2016

Condition

Dry Eye Syndromes

Locations shown

Gordon Binder Weiss Vision Institute

San Diego, California

Kentucky Lion Eye Center, University of Louisville

Louisville, Kentucky

The Ohio State University College of Optometry

Columbus, Ohio

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2016Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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