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NCT00731484 · ClinicalTrials.gov registry record
Validation of TearLab Osmometer - Human Factor Usability Report
A clinical trial, sponsored by TearLab Corporation.
- Completed
- Registry status
- 233
- Enrollment target
NCT00731484: Completed study, sponsored by TearLab Corporation.
NCT00731484 is a clinical trial that has completed, run by TearLab Corporation. The registered enrollment target is 233 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00731484 has completed, sponsored by TearLab Corporation.
- COMPLETED
- Registry status
- 233 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2008-07 |
| Est. Completion | 2009-03 |
What the finished NCT00731484 record still lists
NCT00731484 is an observational study that tracks outcomes without assigning an intervention. The registered 233 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00731484 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00731484 about?
NCT00731484 is a clinical study titled "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.
What is the current status of trial NCT00731484?
This trial is currently completed. The enrollment target is 233 participants. The study started on 2008-07. Estimated completion is 2009-03.
Who is sponsoring clinical trial NCT00731484?
This trial is sponsored by TearLab Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
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