Validation of TearLab Osmometer - Human Factor Usability Report

Completed

Brief Summary: 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.

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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Tear Osmolarity in Human Measured by TearLab System	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.

Secondary Outcome Measures

Name	Time	Method

Locations (3): 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