Effect of gel-based artificial tears on tear film thickness in patients with dry eye disease

Abstract

Purpose : The aim of the present study was to study the effect of a single administration of three gel-based artificial tears on tear film thickness in patients with dry eye disease (DED).

Methods : The study was performed in a randomized, double-masked, parallel group design. 60 patients with DED were included and randomized to receive either Thealoz Duo Gel^® (trehalose 3% + hyaluronic acid 0.15%), Hylo Gel^® (hyaluronic acid 0.20%), or Systane Gel^® (polyethylene glycol 0.4% + propylene glycol 0.3%) eye drops. Tear film thickness (TFT) was measured using a custom built ultrahigh-resolution optical coherence tomography (OCT) system providing a resolution of approximately 1.3 μm in air. Measurements were performed before instillation and 10 min, 30 min, 60 min, 120 min, 240 min and 360 min after administration of the eye drops. In addition, break up time (BUT) and Schirmer I test were assessed.

Results : There was a significant difference in the time course of TFT between the three groups (p=0.001 between groups). Ten minutes after instillation TFT increased by 155.8 ± 86.6 %, 65.7 ± 71.5 % and 33.4 ± 19.6 %, in the Systane Gel^®, Thealoz Duo Gel^® and Hylo Gel^® groups, respectively (p<0.001 between groups). Thirty minutes after instillation, the effect of all 3 different agents on TFT was comparable. Sixty and 120 minutes after administration an increase in TFT was only seen with Thealoz Duo Gel^® but not with the other products (60 min: p<0.021 between groups; 120 min: p<0.037 between groups). No difference in BUT or Schirmer I test results was observed between the three treatments.

Conclusions : In conclusion, significant differences were observed in TFT after administration of the different products. Ten minutes after instillation a pronounced increase in TFT was observed in all groups. As compared to the other products, the combination of trehalose 3% + hyaluronic acid 0.15% offers a longer increase in TFT indicating for a longer residence time.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.