Validation of TearLab Osmometer - Human Factor Usability Report

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.

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.

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.