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

TearLab

Status: Completed

Conditions: Keratoconjunctivitis Sicca

Study type: Observational

Funder types: Industry

Identifiers

NCT00848198

TP00007 OTO

Details and patient eligibility

About

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.

Full description

This is a prospective, observational case series to determine the clinical utility of tear osmolarity, tear film breakup time, corneal fluorescein staining, conjunctival lissamine green staining, Schirmer's test without anesthesia, Bron/Foulks meibomian glan grading and the ocular surface disease index to diagnose dry eye disease, as well as to establish referent values for objective tests of the disease. Patients were recruited across sites in the EU and US from the general clinical population.

Enrollment: 314 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

314 participants in 2 patient groups

Normal

Description:

Subjects with no objective signs of Dry Eye Disease

Dry Eye Disease

Description:

Subjects with objective signs of Dry Eye Disease