Validation of TearLab Osmometer
This study has been completed.
Information provided by:
First received: August 7, 2008
Last updated: April 6, 2011
Last verified: April 2011
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.
||Observational Model: Case Control
Time Perspective: Cross-Sectional
||Validation of TearLab Osmometer
Primary Outcome Measures:
- Whether the Osmolarity/Impedance Calibration Curve of the TearLab Produces Results in Line With Previous in Vivo Measurements of Osmolarity. [ Time Frame: At time of tear osmolarity test. ] [ Designated as safety issue: No ]
The FDA requested that, in addition to the analytical method comparisons to other forms of osmometry produced for the 510(k), that the TearLab be tested in clinical practice to determine whether the non-colligative impedance-based method used to measure osmolarity produced measurements in people consistent with previously published studies. 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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2009 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Ophthalmic and optometric clinics.
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731484
|Gordon Binder Weiss Vision Institute
|San Diego, California, United States, 92130 |
|Kentucky Lion Eye Center, University of Louisville
|Louisville, Kentucky, United States, 40202 |
|The Ohio State University College of Optometry
|Columbus, Ohio, United States, 43210 |
||Michael A Lemp, MD
||Clinical Professor of Ophthalmology, Georgetown University
No publications provided
||VP Regulatory Clinical Operations, TearLab Corporation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 7, 2008
|Results First Received:
||April 6, 2011
||April 6, 2011
||United States: Institutional Review Board
Keywords provided by TearLab Corporation:
ClinicalTrials.gov processed this record on February 27, 2015
Dry Eye Disease