Dry Eye SyndromesNCT00731484

Validation of TearLab Osmometer - Human Factor Usability Report

An observational study of Dry Eye Syndromes, run by TearLab Corporation at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dry Eye Syndromes
How many people: 233 participants
Where: 3 sitesUnited States
Study dates: Jul 2008to Mar 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Ophthalmic and optometric clinics.

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

Read the 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.

Conditions: Dry Eye Syndromes
Keywords: Dry Eye Disease, Tear Osmolarity, Tear Osmolality
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00731484
Study group	Role	What they receive
Volunteer Patients/Subjects		These subjects should present the general population.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Mar 2009

First posted11 Aug 2008 (estimated)
Study startJul 2008
Primary completionMar 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00731484
Sponsor's protocol ID: TP00004
Status last verified: Feb 2016
First submitted: 7 Aug 2008
Last updated: 12 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: The data was used in the FDA 510(K) submission.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland

All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of TearLab Osmometer - Human Factor Usability Report
ClinicalTrials.gov ID: NCT00731484
Acronym / sponsor ID: TP00004
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Disease, Tear Osmolarity, Tear Osmolality
Study type: Observational
Recruitment status: Completed
Enrolment: 233 participants (actual)
Lead sponsor: TearLab CorporationIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 11 Aug 2008 (estimated)
Results: Posted 3 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Volunteer Patients/Subjects	–	–These subjects should present the general population.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Ophthalmic and optometric clinics.

Key inclusion criteria (7 listed)

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,

Key exclusion criteria (7 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Tear Osmolarity in Human Measured by TearLab System
Time frame: 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.

Results and safety

Results posted to the registry on 3 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
General Population	233	233

Primary outcome: Tear Osmolarity in Human Measured by TearLab System

Time frame: Single visit, at time of tear osmolarity testing.. Mean (Full Range). Unit: mOsms/L

Measure	General Population n = 233
Value	308 (275 to 369)

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

Adverse events

Time frame: Time of single visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
General Population	0 of 233 (0%)	0 of 233 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. The data was used in the FDA 510(K) submission.

Related trials for Dry Eye Syndromes

Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael A Lemp, MD study chair

Clinical Professor of Ophthalmology, Georgetown University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Eye Syndromes, run by TearLab Corporation at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tear Osmolarity in Human Measured by TearLab System (time frame: Single visit, at time of tear osmolarity testing.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00731484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2016.