Status:
COMPLETED
Validation of TearLab Osmometer - Human Factor Usability Report
Lead Sponsor:
TearLab Corporation
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
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 ...
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 testin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00731484
Start Date
July 1 2008
End Date
March 1 2009
Last Update
April 12 2016
Active Locations (3)
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1
Gordon Binder Weiss Vision Institute
San Diego, California, United States, 92130
2
Kentucky Lion Eye Center, University of Louisville
Louisville, Kentucky, United States, 40202
3
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43210