TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease

Completed

Conditions studied: Keratoconjunctivitis Sicca

In brief

This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective tests of the disease.

Key facts

Study ID

NCT00848198

Run by

TearLab Corporation

People needed

314

Starts

2009-02-01

Expected to finish

2011-03-01

Last updated by the study team

2016-05-16

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Gordon Binder Weiss Vision Institute — San Diego, California, United States
• Kentucky Lion Eye Center — Louisville, Kentucky, United States
• Pepose Vision Institute — Chesterfield, Missouri, United States
• Tauber Eye Clinic — Kansas City, Missouri, United States
• Mundorf Eye Center — Charlotte, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts — Paris, France
• University of Wurzburg — Würzburg, Germany
• Hospital Clinico San Carlos — Madrid, Spain
• Division of Vision Sciences — Glasgow, Scotland, United Kingdom

Full record on ClinicalTrials.gov

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