Ignite Creation Date:
2024-05-05 @ 9:15 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00848198
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2009-02-18
Brief Title:
TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
Sponsor:
TearLab Corporation
Organization:
TearLab Corporation
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CVS
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 Schirmers test without anesthesia BronFoulks 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None