TearLab Core Validation Study - Full Text View

Sponsor:	TearLab Corporation
Collaborator:	Alcon Research
Information provided by:	TearLab Corporation
ClinicalTrials.gov Identifier:	NCT00848198

Purpose

This is a global study of tear osmolarity using the OcuSense TearLab technology to compare tear samples of age and sex-matched normals with those with Dry Eye Disease (DED). Diagnosis of DED subjects will be established using objective and subjective tests. Positive responses to 3 out of 6 defined criteria determine subjects with DED. DED subjects will be further categorized by severity, using results from the objective and subjective tests. Subjects will be assessed at a single visit.

Condition
Dry Eye Disease

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	A Prospective Study to Establish Normative Values, Demographic Variations, Referent Diagnostic Values and Disease Severity Correlations for Dry Eye Disease and TearLab Osmometry.

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases

U.S. FDA Resources

Further study details as provided by TearLab Corporation:

Primary Outcome Measures:

To establish OcuSense TearLab Osmometry (OTO) normative values, and referent values to diagnose dry eye disease (DED) [ Time Frame: Single site visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To establish the relationship between OTO values and the severity of DED. [ Time Frame: Single site visit ] [ Designated as safety issue: No ]
To assess the effect on diagnostic accuracy of adding additional categories of diagnostic test results, e.g. Ocular Surface Disease Index (OSDI) and /or Tear Break-up Film Test (TBUT). [ Time Frame: Single Site Visit ] [ Designated as safety issue: No ]
To assess the effect of age and sex on the range of OTO values in normal subjects [ Time Frame: Single site visit ] [ Designated as safety issue: No ]
To establish the variance of right eye (RE)/left eye (LE) OTO values in normal subjects and in subjects with DED [ Time Frame: Single site visit ] [ Designated as safety issue: No ]
To establish the accuracy of single eye OTO values versus bilateral values in diagnosing DED. [ Time Frame: Single Site Visit ] [ Designated as safety issue: No ]
To assess the range of OTO values in symptomatic subjects without signs of DED and in DED subjects of varying severity as judged by the clinical severity scale. [ Time Frame: Single Site Visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	February 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 200 subjects with no history of Dry Eye Disease either by symptoms or diagnosis,
2 300 subjects with positive Dry Eye Disease history.

Detailed Description:

This is a multicenter study. A total of 500 subjects are expected to be enrolled at 10 sites located in the United States, Europe and Japan. It is anticipated that each site will enroll approximately 50 subjects.

Objectives:

Primary: To establish OcuSense TearLab Osmometry (OTO) normative values, and referent values to diagnose dry eye disease (DED)
Secondary:
To establish the relationship between OTO values and the severity of DED.
To assess the effect on diagnostic accuracy of adding additional categories of diagnostic test results, e.g. Ocular Surface Disease Index (OSDI) and /or Tear Break-up Film Test (TBUT).
To assess the effect of age and sex on the range of OTO values in normal subjects.
To establish the variance of right eye (RE)/left eye (LE) OTO values in normal subjects and in subjects with DED.
To establish the accuracy of single eye OTO values versus bilateral values in diagnosing DED.
To assess the range of OTO values in symptomatic subjects without signs of DED and in DED subjects of varying severity as judged by the clinical severity scale.

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Ophthalmology and Optometry Clinics

Criteria

Inclusion Criteria:

Be between the ages of 18 and 79 years of age.
Must understand and be able, willing and likely to fully comply with study procedures and restrictions.

Exclusion Criteria:

Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia..
Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for Dry Eye Disease, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
Active ocular allergy.
LASIK or PRK surgery that was performed within one year of Visit 1.
Started or changed the dose of chronic ocular medication within 30 days of visit 1.
Contact lens worn within the past eight (8) hours.
Any ophthalmologic drops within 2 hours of screening and visit 1 procedures.
Pregnancy or lactation.
Abnormality of nasolacrimal drainage (by history).
Punctual plugs placement or cauterization within 30 days of Visit 1
Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Visit 1.
Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days of Visit 1.
Known hypersensitivity to any of the agents used in testing i.e. sodium fluorescein, lissamine green, oxybuprocaine or proparacaine.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848198

Locations

United States, California
Gordon Binder Weiss Vision Institute
San Diego, California, United States, 92130
United States, Kentucky
Kentucky Lion Eye Center
Louisville, Kentucky, United States, 40202
United States, Missouri
Pepose Vision Institute
Chesterfield, Missouri, United States, 63017
Tauber Eye Clinic
Kansas City, Missouri, United States, 63017
United States, North Carolina
Mundorf Eye Center
Charlotte, North Carolina, United States, 28204
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
France
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, France
Germany
University of Wurzburg
Wurzburg, Germany
Italy
Clinica Oculistica, Univ of Genoa
Genoa, Italy
Japan
Keio University School of Medicine
Tokyo, Japan
Spain
Hospital Clinico San Carlos
Madrid, Spain
United Kingdom
Division of Vision Sciences
Glasgow, Scotland, United Kingdom
Royal Victoria Infirmary New Castle-upon-Tynee
Newcastle Upon Tyne, United Kingdom

Sponsors and Collaborators

TearLab Corporation

Alcon Research

Investigators

Study Chair:

Gary Foulks, MD

Kentucky Lions Eye Center, University of Louisville

More Information

No publications provided by TearLab Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lemp MA, Bron AJ, Baudouin C, Benítez Del Castillo JM, Geffen D, Tauber J, Foulks GN, Pepose JS, Sullivan BD. Tear osmolarity in the diagnosis and management of dry eye disease. Am J Ophthalmol. 2011 May;151(5):792-798.e1. Epub 2011 Feb 18.

Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. Epub 2010 Jul 14.

Responsible Party:	VP Regulatory Clinical Operations, TearLab Corporation
ClinicalTrials.gov Identifier:	NCT00848198 History of Changes
Other Study ID Numbers:	TP00007 OTO
Study First Received:	February 18, 2009
Last Updated:	February 2, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by TearLab Corporation:

Dry Eye Disease
Dry Eye Syndrome
Dry Eye

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis

Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on February 09, 2012