Validation of TearLab Osmometer

This study has been completed.
Sponsor:
Information provided by:
TearLab Corporation
ClinicalTrials.gov Identifier:
NCT00731484
First received: August 7, 2008
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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.


Condition
Dry Eye Syndromes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Validation of TearLab Osmometer

Resource links provided by NLM:


Further study details as provided by TearLab Corporation:

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.


Enrollment: 233
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Ophthalmic and optometric clinics.

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.
  Contacts and Locations
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

Locations
United States, California
Gordon Binder Weiss Vision Institute
San Diego, California, United States, 92130
United States, Kentucky
Kentucky Lion Eye Center, University of Louisville
Louisville, Kentucky, United States, 40202
United States, Ohio
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
TearLab Corporation
Investigators
Study Chair: Michael A Lemp, MD Clinical Professor of Ophthalmology, Georgetown University
  More Information

No publications provided

Responsible Party: VP Regulatory Clinical Operations, TearLab Corporation
ClinicalTrials.gov Identifier: NCT00731484     History of Changes
Other Study ID Numbers: TP00004
Study First Received: August 7, 2008
Results First Received: April 6, 2011
Last Updated: April 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by TearLab Corporation:
Dry Eye Disease
Tear Osmolarity
Tear Osmolality

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on October 23, 2014