Clinical trial NCT00848198: TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
Official title: A Prospective Study to Establish Normative Values, Demographic Variations, Referent Diagnostic Values and Disease Severity Correlations for Dry Eye Disease and TearLab Osmometry.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconjunctivitis Sicca
Keywords: Dry Eye Disease
Dry Eye Syndrome
Dry Eye
Lead sponsor: TearLab Corporation
Sponsor class: INDUSTRY
Collaborators: name: Alcon Research
First posted: 2009-02-20
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ophthalmology and Optometry Clinics

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L
timeFrame: Single visit
measure: Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm
timeFrame: Single visit
measure: Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds
timeFrame: Single visit
measure: Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15
timeFrame: Single visit
measure: Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12
timeFrame: Single visit
measure: Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27
timeFrame: Single visit
measure: Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100
timeFrame: Single visit
Secondary outcomes:
measure: Referent Values for Tear Osmolarity
timeFrame: Single visit
measure: Referent Values for Schirmer Test
timeFrame: Single visit
measure: Referent Values for Tear Film Breakup Time
timeFrame: Single visit
measure: Referent Values for Corneal Staining
timeFrame: Single visit
measure: Referent Values for Conjunctival Staining
timeFrame: Single visit
measure: Referent Values for Meibomian Gland Grading
timeFrame: Single visit
measure: Referent Values for Ocular Surface Disease Index
timeFrame: Single visit
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Gordon Binder Weiss Vision Institute
state: California
city: Louisville
country: United States
facility: Kentucky Lion Eye Center
state: Kentucky
city: Chesterfield
country: United States
facility: Pepose Vision Institute
state: Missouri
city: Kansas City
country: United States
facility: Tauber Eye Clinic
state: Missouri
city: Charlotte
country: United States
facility: Mundorf Eye Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Paris
country: France
facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
city: Wurzburg
country: Germany
facility: University of Wurzburg
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Glasgow
country: United Kingdom
facility: Division of Vision Sciences
state: Scotland
Study officials:
affiliation: Kentucky Lions Eye Center, University of Louisville
name: Gary Foulks, MD
role: STUDY_CHAIR
References:
citation: Lemp MA, Bron AJ, Baudouin C, Benitez Del Castillo JM, Geffen D, Tauber J, Foulks GN, Pepose JS, Sullivan BD. Tear osmolarity in the diagnosis and management of dry eye disease. Am J Ophthalmol. 2011 May;151(5):792-798.e1. doi: 10.1016/j.ajo.2010.10.032. Epub 2011 Feb 18.
citation: Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14.
citation: Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012 May;31(5):472-8. doi: 10.1097/ICO.0b013e318225415a.