Abstract
Purpose: :
To explore the relationships between tear osmolarity and other measures of dry eye signs and symptoms in subjects with moderate to severe dry eye disease.
Methods: :
Tear osmolarity, Schirmer score, tear break-up time, total fluorescein corneal staining score, and symptoms (total ocular symptom score) were collected in a well-controlled, randomized, double-masked, multi-center study of 168 subjects with moderate to severe dry eye disease. The TearLab™ Osmolarity System was used to assess tear osmolarity at several visits. Pair-wise correlations between tear osmolarity and other efficacy measures at each visit were calculated for OD and OS, separately. The number of subjects involved in the correlation analysis varied by visit and ranged from 133 to 168.
Results: :
Very weak correlations were found between tear osmolarity and Schirmer score (-0.16 to -0.05 for OD; -0.14 to -0.03 for OS), tear break-up time (-0.22 to 0.01 for OD; -0.24 to 0.12 for OS), total fluorescein corneal staining score (-0.02 to 0.19 for OD; and -0.01 to 0.17 for OS), and total ocular symptom score (-0.03 to 0.23 for OD; -0.02 to 0.06 for OS).
Conclusions: :
Based on the weakness of the correlations seen, tear osmolarity alone, as measured in this study, may not be as helpful a tool as assumed. However, based on the directions of those correlations, in conjunction with other dry eye signs and symptoms, it could be used to confirm the diagnosis of dry eye disease.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01239069
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • clinical (human) or epidemiologic studies: biostatistics/epidemiology methodology • clinical (human) or epidemiologic studies: outcomes/complications