CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 314 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 2
  • ✓Age 18-79 years
  • ✓Able and willing to comply with study procedures
Key exclusion· 13
  • ✕Clinically significant eyelid deformity or movement disorder (notch deformity, incomplete lid closure, entropion, ectropion, hordeola, chalazia)
  • ✕Prior ocular disease with sequelae or requiring current topical therapy (except dry eye), including active corneal/conjunctival infection or ocular surface scarring
  • ✕Active ocular allergy
  • ✕LASIK or PRK surgery within one year of Visit 1

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00848198
NCT00848198N/ACompleted
CompareCT.gov

A Prospective Study to Establish Normative Values, Demographic Variations, Referent Diagnostic Values and Disease Severity Correlations for Dry Eye Disease and TearLab Osmometry.

TearLab Corporation·observational·Posted Feb 20, 2009·Updated May 16, 2016

In Brief

An observational study for Keratoconjunctivitis Sicca. Completed, enrolled 314 participants across 10 sites in 5 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsKeratoconjunctivitis Sicca
CountriesFrance, Germany, Spain, United Kingdom, United States
CollaboratorsAlcon Research

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2009
Enrollment StartFeb 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.4 years ago