Trial Outcomes & Findings for Validation of TearLab Osmometer - Human Factor Usability Report (NCT NCT00731484)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

233 participants

Primary outcome timeframe

Single visit, at time of tear osmolarity testing.

Results posted on

2016-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	General Population 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 Study STARTED	233
Overall Study COMPLETED	233
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation of TearLab Osmometer - Human Factor Usability Report

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	General Population n=233 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	191 Participants n=5 Participants
Age, Categorical >=65 years	42 Participants n=5 Participants
Age, Continuous	47.8 years STANDARD_DEVIATION 18.0 • n=5 Participants
Sex: Female, Male Female	159 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants
Region of Enrollment United States	233 participants n=5 Participants

PRIMARY outcome

Timeframe: Single visit, at time of tear osmolarity testing.

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

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.

Outcome measures

Outcome measures
Measure	General Population n=233 Participants Subjects were recruited from patients presenting for a routine visit at the physician office study sites
Tear Osmolarity in Human Measured by TearLab System	308 mOsms/L Interval 275.0 to 369.0

Adverse Events

General Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Benjamin Sullivan

TearLab, Inc.

Phone: 855-832-7522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place