Validation of TearLab Osmometer

Dry Eye Syndromes Clinical Trial

Official title:

Validation of TearLab Osmometer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731484
• Other study ID #: TP00004
• Status: Completed
• Phase: N/A
• First received: August 7, 2008
• Last updated: April 6, 2011
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2011
• Source: TearLab Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
United States	The Ohio State University College of Optometry	Columbus	Ohio
United States	Kentucky Lion Eye Center, University of Louisville	Louisville	Kentucky
United States	Gordon Binder Weiss Vision Institute	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
TearLab Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether the Osmolarity/Impedance Calibration Curve of the TearLab Produces Results in Line With Previous in Vivo Measurements of Osmolarity.	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.	At time of tear osmolarity test.	No