TearLab Core Validation Study - Full Text View

Sponsors and Collaborators:	OcuSense, Inc Alcon Research
Information provided by:	OcuSense, Inc
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:	Case Control, 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 OcuSense, Inc:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	February 2009
Estimated Study Completion Date:	September 2009
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

Contacts

Contact: Michael Berg

mberg@tearlab.com

Locations

United States, California
Gordon Binder Weiss Vision Institute	Recruiting
San Diego, California, United States, 92130
Principal Investigator: Geffen, OD
United States, Kentucky
Kentucky Lion Eye Center	Not yet recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: Foulks, MD
United States, Missouri
Pepose Vision Institute	Recruiting
Chesterfield, Missouri, United States, 63017
Principal Investigator: Pepose, MD
Tauber Eye Clinic	Recruiting
Kansas City, Missouri, United States, 63017
Principal Investigator: Tauber, MD
United States, North Carolina
Mundorf Eye Center	Recruiting
Charlotte, North Carolina, United States, 28204
Principal Investigator: Mundorf, MD
United States, Ohio
Ohio State University	Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Nichols, OD
France
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts	Not yet recruiting
Paris, France
Principal Investigator: Baudouin, MD
Germany
University of Wurzburg	Recruiting
Wurzburg, Germany
Principal Investigator: Geerling, MD
Italy
Clinica Oculistica, Univ of Genoa	Recruiting
Genoa, Italy
Principal Investigator: Rolando, MD
Japan
Keio University School of Medicine	Recruiting
Tokyo, Japan
Principal Investigator: Tsubota, MD
Principal Investigator: Dogru, MD
Spain
Hospital Clinico San Carlos	Recruiting
Madrid, Spain
Principal Investigator: Benitez del Castillo, MD
United Kingdom
Royal Victoria Infirmary New Castle-upon-Tynee	Not yet recruiting
Newcastle upon Tyne, United Kingdom
Principal Investigator: Figuerido, MD, PhD
United Kingdom, Scotland
Division of Vision Sciences	Recruiting
Glasgow, Scotland, United Kingdom
Principal Investigator: Tomlinson, PhD

Sponsors and Collaborators

OcuSense, Inc

Alcon Research

Investigators

Study Chair:

Gary Foulks, MD

Kentucky Lions Eye Center, University of Louisville

More Information

No publications provided

Responsible Party:	OcuSense, Inc ( VP Regulatory Clinical Operations )
Study ID Numbers:	TP00007 OTO
Study First Received:	February 18, 2009
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00848198 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by OcuSense, Inc:

Dry Eye Disease
Dry Eye Syndrome
Dry Eye

Study placed in the following topic categories:

Eye Diseases
Dry Eye Syndromes

Additional relevant MeSH terms:

Eye Diseases

ClinicalTrials.gov processed this record on August 30, 2009