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TearLab Core Validation Study - NCT00848198-28204(Clinical Trial 273470)



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City:  Charlotte
State:  
NC
Zip Code: 28204
Conditions: Dry Eye Disease
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.
Study summary: 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.
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.
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Data Source: ClinicalTrials.gov
Date Processed: February 2, 2010
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