Trials / Completed
CompletedNCT00731484
Validation of TearLab Osmometer - Human Factor Usability Report
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 233 (actual)
- Sponsor
- TearLab Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2008-08-11
- Last updated
- 2016-04-12
- Results posted
- 2011-05-03
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00731484. Inclusion in this directory is not an endorsement.