TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
NCT ID: NCT00848198
Last Updated: 2016-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
314 participants
OBSERVATIONAL
2009-02-28
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Normal
Subjects with no objective signs of Dry Eye Disease
No interventions assigned to this group
Dry Eye Disease
Subjects with objective signs of Dry Eye Disease
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Must understand and be able, willing and likely to fully comply with study procedures and restrictions.
Exclusion Criteria
* 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.
18 Years
79 Years
ALL
Yes
Sponsors
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Alcon Research
INDUSTRY
TearLab Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gary Foulks, MD
Role: STUDY_CHAIR
Kentucky Lions Eye Center, University of Louisville
Locations
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Gordon Binder Weiss Vision Institute
San Diego, California, United States
Kentucky Lion Eye Center
Louisville, Kentucky, United States
Pepose Vision Institute
Chesterfield, Missouri, United States
Tauber Eye Clinic
Kansas City, Missouri, United States
Mundorf Eye Center
Charlotte, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, , France
University of Wurzburg
Würzburg, , Germany
Hospital Clinico San Carlos
Madrid, , Spain
Division of Vision Sciences
Glasgow, Scotland, United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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TP00007 OTO
Identifier Type: -
Identifier Source: org_study_id
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