Validation of TearLab Osmometer - Full Text View

Purpose

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

Dry Eye Disease

MedlinePlus related topics:

Eye Diseases

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional

Official Title:	Validation of TearLab Osmometer

Further study details as provided by OcuSense, Inc:

Primary Outcome Measures:

TearLab tear osmolarity referent values of normal and Dry Eye subjects. [ Time Frame: At time of tear osmolarity test. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	240
Study Start Date:	July 2008

Groups/Cohorts

1

2

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Ophthalmic and optometric clinics.

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731484

Contacts


Contact: Michael S Berg	858-794-1422	mberg@tearlab.com

Locations


United States, California
	Gordon Binder Weiss Vision Institute	Recruiting
	San Diego, California, United States, 92130

United States, Kentucky
	Kentucky Lion Eye Center, University of Louisville	Recruiting
	Louisville, Kentucky, United States, 40202

United States, Ohio
	The Ohio State University College of Optometry	Recruiting
	Columbus, Ohio, United States, 43210

Sponsors and Collaborators

OcuSense, Inc

More Information

Responsible Party:	OcuSense, Inc. ( VP Regulatory Clinical Operations )
Study ID Numbers:	TP00004
First Received:	August 7, 2008
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00731484
Health Authority:	United States: Institutional Review Board

Keywords provided by OcuSense, Inc:

Dry Eye Disease

Tear Osmolarity

Tear Osmolality

Study placed in the following topic categories:

Lacerations

Eye Diseases

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	OcuSense, Inc
Information provided by:	OcuSense, Inc
ClinicalTrials.gov Identifier:	NCT00731484