NCT00848198

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

A Prospective Study to Establish Normative Values, Demographic Variations, Referent Diagnostic Values and Disease Severity Correlations for Dry Eye Disease and TearLab Osmometry.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 314 (actual)
• Sponsor: TearLab Corporation · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Keratoconjunctivitis Sicca

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-02-20
• Last updated: 2016-05-16
• Results posted: 2016-04-14

Locations

10 sites across 5 countries: United States, France, Germany, Spain, United Kingdom