Dry Eye Syndromes
Conditions
Keywords
Dry Eye Disease, Tear Osmolarity, Tear Osmolality
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.
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.
Interventions
None listed
Sponsors
TearLab Corporation
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 233 |
| Total | 233 |
Baseline characteristics
| Characteristic | General Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 42 Participants |
| Age, Categorical Between 18 and 65 years | 191 Participants |
| Age, Continuous | 47.8 years STANDARD_DEVIATION 18 |
| Region of Enrollment United States | 233 participants |
| Sex: Female, Male Female | 159 Participants |
| Sex: Female, Male Male | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 233 |
| serious Total, serious adverse events | 0 / 233 |
Outcome results
Primary
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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| General Population | Tear Osmolarity in Human Measured by TearLab System | 308 mOsms/L |