Validation of TearLab Osmometer - Human Factor Usability Report

• Sponsor: TearLab Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00731484
• Collaborator: (none)
• Enrollment: 233
• Locations: 3
• Duration (Months): 8
• Patients Per Site: 77.7
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 233 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Validation of TearLab Osmometer - Human Factor Usability Report
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Volunteer Patients/Subjects These subjects should present the general population.

Outcome Measures

Primary Outcome Measures

1. Tear Osmolarity in Human Measured by TearLab System [Single visit, at time of tear osmolarity testing.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Gordon Binder Weiss Vision Institute	San Diego	California	United States	92130
2	Kentucky Lion Eye Center, University of Louisville	Louisville	Kentucky	United States	40202
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TearLab Corporation
• ClinicalTrials.gov Identifier: NCT00731484
• Other Study ID Numbers: TP00004
• First Posted: Aug 11, 2008
• Last Update Posted: Apr 12, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by TearLab Corporation: Dry Eye Disease; Tear Osmolarity; Tear Osmolality
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

Participant Flow

Arm/Group Title	General Population
Arm/Group Description	Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
Period Title: Overall Study
STARTED	233
COMPLETED	233
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	General Population
Arm/Group Description	Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
Overall Participants	233
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	191 82%
>=65 years	42 18%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.8 (18.0)
Sex: Female, Male (Count of Participants)
Female	159 68.2%
Male	74 31.8%
Region of Enrollment (participants) [Number]
United States	233 100%

Outcome Measures

1. Primary Outcome

Title	Tear Osmolarity in Human Measured by TearLab System
Description	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.
Time Frame	Single visit, at time of tear osmolarity testing.

Outcome Measure Data

Analysis Population Description

Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens Syndrome

Arm/Group Title	General Population
Arm/Group Description	Subjects were recruited from patients presenting for a routine visit at the physician office study sites
Measure Participants	233
Mean (Full Range) [mOsms/L]	308

Adverse Events

Time Frame	Time of single visit
Adverse Event Reporting Description	No side effects were observed or reported.
Arm/Group Title	General Population
Arm/Group Description	Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
All Cause Mortality
	General Population
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	General Population
	Affected / at Risk (%)	# Events
Total	0/233 (0%)
Other (Not Including Serious) Adverse Events
	General Population
	Affected / at Risk (%)	# Events
Total	0/233 (0%)

Limitations/Caveats

As recruitment came from the general clinical population, only 19 subjects were classified as having Sjögren's Syndrome, and few of the subjects had severe dry eye. Therefore, the upper range is lower than we have observed in the following studies.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.