Validation of TearLab Osmometer - Human Factor Usability Report

Completed

Conditions studied: Dry Eye Syndromes

In brief

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.

Key facts

Study ID

NCT00731484

Run by

TearLab Corporation

People needed

233

Starts

2008-07-01

Expected to finish

2009-03-01

Last updated by the study team

2016-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Gordon Binder Weiss Vision Institute — San Diego, California, United States
• Kentucky Lion Eye Center, University of Louisville — Louisville, Kentucky, United States
• The Ohio State University College of Optometry — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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