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

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.