Abstract
Purpose: :
To correlate tear osmolarity (TO) with severity of dry eye disease (DED) as assessed by clinician and subject global assessment questionnaires at baseline and 3 months after supplementation with either placebo or Omega3 Fatty Acid.
Methods: :
Eighteen patients diagnosed with DED were recruited. Patients answered questionnaires regarding symptom severity (0=best, 10=worst) and its effect on daily activities (0=not at all, 10= extremely) at baseline and at 3 months. Completed questionnaires were placed in sealed envelopes before submitting to a masked clinician examiner. Standard dry eye evaluation, including corneal and conjunctival staining with fluorescein and lissamine green, Schirmer’s tests, and tear break- up time, were then performed. Clinicians completed the question on the overall DED condition (0=best, 10= worst). Patients and clinicians also rated the change from baseline at 3 months (1=very much worse, 7=very much better). TO was measured in each eye at each visit (TearLab Osmolarity System) prior to eye exam, by independent observer. Spearman correlation coefficients were used to describe the correlation between assessment responses and TO.
Results: :
At baseline, median (minimum, maximum) values were 6 (2,10) for patient’s symptoms, 6 (2,10) for patient’s distress, 7 (2,9) for clinicians assessment of overall condition and 307.5 (284.5, 321.0) for the average TO. Correlations between the patient symptom rating (r=0.04; p=.87) and patient distress rating (r=.13; p=.60) and osmolarity were low and not statistically significant. The correlation between clinician’s overall rating (r=-.31; p=0.21) and TO was inverse, low, and not statistically significant. At 3 months, the values were 4 (1,7) for patient’s assessment of change, 4 (4,7) for clinician’s assessment of change, and 1.0(-31.5, +28.0) for TO. Correlations between changes in TO and the patient’s assessment of change in symptoms (r=0.03; p=.90) and clinician’s assessment of change in overall condition (r=0.02, p=.93) were nearly 0.
Conclusions: :
In this small sample size of patients with mild to moderate DED, TO was not related to either patients’ or clinicians’ assessments of symptom severity or overall condition. Changes in tear osmolarity were not correlated with changes in patient and clinician assessments of change in status.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01102257
Keywords: cornea: tears/tear film/dry eye