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NCT00848198 · ClinicalTrials.gov registry record
TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
A clinical trial of Keratoconjunctivitis Sicca, sponsored by TearLab Corporation.
- Completed
- Registry status
- 314
- Enrollment target
- 10
- Study locations
NCT00848198: Completed study of Keratoconjunctivitis Sicca, sponsored by TearLab Corporation.
NCT00848198 is a study of Keratoconjunctivitis Sicca that has completed, run by TearLab Corporation. The registered enrollment target is 314 participants, above the 146-participant average among 10 other Keratoconjunctivitis Sicca trials with a reported enrollment target (115% higher). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00848198, a study of Keratoconjunctivitis Sicca, has completed, sponsored by TearLab Corporation.
- COMPLETED
- Registry status
- 314 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
Tear osmolarity was measured with a laboratory-on-a-chip, to simultaneously collect and analyze the electrical impedance of a 50 nL tear sample from the interior lateral meniscus (TearLab Osmolarity System). A cutoff threshold of more than 308 mOsm/L was used for differentiating normal from mild to moderate subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Quest
Conditions Studied
Study Locations (10)
Other
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts - Paris
- University of Wurzburg - Würzburg
- Hospital Clinico San Carlos - Madrid
Missouri
- Pepose Vision Institute - Chesterfield
- Tauber Eye Clinic - Kansas City
California
- Gordon Binder Weiss Vision Institute - San Diego
Kentucky
- Kentucky Lion Eye Center - Louisville
North Carolina
- Mundorf Eye Center - Charlotte
Ohio
- Ohio State University - Columbus
Scotland
- Division of Vision Sciences - Glasgow
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-03 |
What the finished NCT00848198 record still lists
NCT00848198 is an observational study that tracks outcomes without assigning an intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, above the 146-participant average among 10 other Keratoconjunctivitis Sicca trials with a reported enrollment target (115% higher).
The record links to 1 condition, with Keratoconjunctivitis Sicca appearing as the primary indexed condition, and to 0 interventions.
NCT00848198 lists 10 locations in 7 states (Other, Missouri, California).
Frequently Asked Questions
What is clinical trial NCT00848198 about?
NCT00848198 is a clinical study titled "TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease". 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.
What is the current status of trial NCT00848198?
This trial is currently completed. The enrollment target is 314 participants. The study started on 2009-02. Estimated completion is 2011-03.
What conditions does trial NCT00848198 study?
This clinical trial studies the following conditions: Keratoconjunctivitis Sicca.
Who is sponsoring clinical trial NCT00848198?
This trial is sponsored by TearLab Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00848198 being conducted?
This trial has 10 study locations across California, Kentucky, Missouri, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00848198's enrollment target sits among peer trials
314 3rd of 10 higher than 8 of 10 other Keratoconjunctivitis Sicca trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Keratoconjunctivitis Sicca trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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