An observational study in Dry Eye Syndromes, sponsored by TearLab Corporation. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-12.
Sponsored by TearLab Corporation · Observational
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 233 is above the median of 90 across 171 observational studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →TearLab Corporation is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Ophthalmic and optometric clinics.
Exclusion Criteria:
These subjects should present the general population.
Tear Osmolarity in Human Measured by TearLab System
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.
Time frame: Single visit, at time of tear osmolarity testing.
| Milestone | General Population |
|---|---|
| Started | 233 |
| Completed | 233 |
| Not completed | 0 |
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.
| mOsms/L | General Population |
|---|---|
| Tear Osmolarity in Human Measured by TearLab System | 308 (275 to 369) |
Collected over Time of single visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| General Population | — | 0/233 (0%) | 0/233 (0%) |
| Age, Categorical(Participants) | General Population |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 191 |
| >=65 years | 42 |
| Age, Continuous(years) | General Population |
|---|---|
| Mean | 47.8 ± 18.0 |
| Sex: Female, Male(Participants) | General Population |
|---|---|
| Female | 159 |
| Male | 74 |
| Region of Enrollment(participants) | General Population |
|---|---|
| United States | 233 |
Plan to share: Yes — The data was used in the FDA 510(K) submission.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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