N/A
N=233
Validation of TearLab Osmometer - Human Factor Usability Report
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00731484 ↗Enrolled (actual)
233
Serious AEs
0.0%
Results posted
May 2011
Primary outcome: Primary: Tear Osmolarity in Human Measured by TearLab System — 308 mOsms/L
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TearLab Corporation
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Osmolarity in Human Measured by TearLab System |
308 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00731484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.