Abstract
Purpose :
In patients suffering from Sjögren’s syndrome, eye surface staining is more prominent, tear secretion is decreased, and subjective symptoms are significant. First-line therapy of this disease is tear supplementation. In case of corneal complications or serious subjective symptoms, topical or systemic anti-inflammatory therapy may be advantageous. The chronic use of both topical and systemic anti-inflammatory drugs may cause various side effects.
Methods :
21 patients (18 female, 3 male) were enrolled into our prospective, unmasked, self-controlled study. The mean age of patients was 60.4±11.4 years. All patients fulfilled our inclusion criteria: lid parallel conjunctival folds (LIPCOF) > grade 1, lissamine green staining in Oxford scheme grade > grade 2, decreased tear secretion, significant subjective symptoms [ocular surface disease index (OSDI)], diagnosis of Sjögren’s syndrome. All subjects used artificial tears before the study. During the study period, the subjects used a preservative-free, unit-dose artificial tear, Conheal®, containing isotonic glycerol and 0.015% sodium hyaluronate four times a day for three months. The patients had three visits during this period. Ordinal data and non-normally distributed data were analyzed by non-parametric Wilcoxon Signed Rank Test, meanwhile, normally distributed data were compared by Paired T Test using SPSS Statistics 22. The number of participants was verified by power analysis.
Results :
The three-month long use of Conheal® resulted in a decrease of the LIPCOF degree from the initial 2.48±0.75 on the right eyes and 2.57±0.75 on the left eyes to 1.33±0.73 and 1.38±0.67, respectively (Pright<0.001, Pleft<0.001). The initial lissamine green staining of the eye surface also decreased significantly (Pright=0.001, Pleft<0.001) from 1.76±0.89 and 1.95±0.86 to 0.29±0.56 and 0.29±0.56, respectively. There was a significant decrease (P<0.001) in the OSDI values from 55.81±15.19 to 32.54±19.51. Tear secretion did not change significantly (Pright=0.38, Pleft=0.45).
Conclusions :
Our results show that using the investigated artificial tear resulted in a significant improvement of the subjective and objective symptoms of the Sjögren's syndrome-related dry eye disease, without the need of anti-inflammatory agents. We suspect, based on in vitro experiments, that isotonic glycerol-induced decrease of HLA-DR expression may be responsible for this favorable effect.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.