TearLab Core Validation Study

Dry Eye Disease Clinical Trial

— CVS  

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00848198
• Other study ID #: TP00007 OTO
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 18, 2009
• Last updated: February 2, 2010
• Start date: February 2009
• Est. completion date: July 2010

Study information

• Verified date: February 2010
• Source: TearLab Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: July 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
TearLab Corporation	Alcon Research

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Japan,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish OcuSense TearLab Osmometry (OTO) normative values, and referent values to diagnose dry eye disease (DED)		Single site visit	No
Secondary	To establish the relationship between OTO values and the severity of DED.		Single site visit	No
Secondary	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).		Single Site Visit	No
Secondary	To assess the effect of age and sex on the range of OTO values in normal subjects		Single site visit	No
Secondary	To establish the variance of right eye (RE)/left eye (LE) OTO values in normal subjects and in subjects with DED		Single site visit	No
Secondary	To establish the accuracy of single eye OTO values versus bilateral values in diagnosing DED.		Single Site Visit	No
Secondary	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.		Single Site Visit	No