Validation of TearLab Osmometer - Human Factor Usability Report

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 233

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92130
      • Gordon Binder Weiss Vision Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kentucky Lion Eye Center, University of Louisville
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Ophthalmic and optometric clinics.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Volunteer Patients/Subjects; These subjects should present the general population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Single visit, at time of tear osmolarity testing.

Collaborators and Investigators

• Sponsor: TearLab Corporation
• Investigators: Study Chair: Michael A Lemp, MD, Clinical Professor of Ophthalmology, Georgetown University

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): March 1, 2009

Study Registration Dates

• First Submitted: August 7, 2008
• First Submitted That Met QC Criteria: August 8, 2008
• First Posted (ESTIMATE): August 11, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 12, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Dry Eye Disease; Tear Osmolarity; Tear Osmolality
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: TP00004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data was used in the FDA 510(K) submission.