Efficacy of a New Tear Substitute Containing Hyaluronic Acid and a Low Dose of Hydrocortisone in Dry Eye Disease

Abstract

Purpose : To evaluate the effect of a new tear substitute containing hyaluronic acid (HA) and a low dose (0.001%) of hydrocortisone in patients with dry eye disease in a randomized, double-masked pilot study.

Methods : Dry eye and treatment outcomes were assessed by SANDE questionnaire, Schirmer I test, tear BUT, conjunctival staining by using a new formulation of liquid lissamine green, and fluorescein corneal staining (baseline, day 7 and 28). Immune cells (CD45⁺, CD14⁺, CD4⁺, CD8⁺) were detected by impression cytology and flow cytometry at baseline and day 28. All patients (n=40) received fluorometholone eye drops bid for one week. The study group used the new tear substitute (Idroflog, Alfa Intes, Italy) bid for one week and qid for three weeks; the control group used HA alone with the same regimen. Intraocular pressure (IOP) was recorded at baseline, day 7 and 28.

Results : Severity and frequency of symptoms were improved in both groups at day 7 and 28. Fluorescein and liquid lissamine green staining were significantly decreased at day 30 in the study group respect to the control (p≤ 0.05). No significant changes were recorded for Schirmer test and BUT. While CD45⁺ cells were decreased in both groups, CD14⁺ cells and the CD4/CD8 ratio significantly decreased in the study group only (p≤ 0.05). None of the treated eyes showed significant increase in IOP at day 28.

Conclusions : The results show the efficacy of a new a tear substitute to improve signs of dry eye, and to control inflammation over time. Further results are expected at a longer follow up (6 months), but the importance of chronic use of tear substitutes containing low percentage of steroids in dry eye seems to be demonstrated.

This is a 2021 ARVO Annual Meeting abstract.