Status:
COMPLETED
TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
Lead Sponsor:
TearLab Corporation
Collaborating Sponsors:
Alcon Research
Conditions:
Keratoconjunctivitis Sicca
Eligibility:
All Genders
18-79 years
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 refer...
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, Schi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT00848198
Start Date
February 1 2009
End Date
March 1 2011
Last Update
May 16 2016
Active Locations (10)
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1
Gordon Binder Weiss Vision Institute
San Diego, California, United States, 92130
2
Kentucky Lion Eye Center
Louisville, Kentucky, United States, 40202
3
Pepose Vision Institute
Chesterfield, Missouri, United States, 63017
4
Tauber Eye Clinic
Kansas City, Missouri, United States, 63017