The HYLAN M Study: Efficacy of 0.15% High Molecular Weight Hyaluronan Fluid in the Treatment of Severe Dry Eye Disease in a Multicenter Randomized Trial.

Gysbert-Botho Van Setten,Ria Beck,Daniel Böhringer,Berthold Seitz,Stefano Barabino,Ebru Toker,Wolfgang G.K Müller-Lierheim,Jutta Horwath-Winter,Jose M Benitez-Del-Castillo,Osama Al-Sheikh,Herbert A Reitsamer,Sultan Al-Zaaidi,Oliver Stachs,Christophe Baudouin

doi:10.3390/jcm9113536

Abstract

The aim of the HYLAN M study was to investigate if symptoms and/or signs of patients suffering from severe dry eye disease (DED) can be improved by substituting individually optimized artificial tear therapy by high molecular weight hyaluronan (HMWHA) eye drops. In this international, multicenter study, patients with symptoms of at least ocular surface disease index (OSDI) 33 and corneal fluorescein staining (CFS) of at least Oxford grade 3 were included. A total of 84 per-protocol patients were randomized in two study arms. The control group continued to use their individual optimum artificial tears over the study period of eight weeks; in the verum group, the artificial tears were substituted by eye drops containing 0.15% HMWHA. At the week 8 visit, the average OSDI of the verum group had improved by 13.5 as compared to the control group (p = 0.001). The best corrected visual acuity (BCVA) had improved by 0.04 logMAR (p = 0.033). CFS, tear film break-up time (TBUT), Schirmer I, lid wiper epitheliopathy (LWE), mucocutaneous junction (Yamaguchi score), and tear osmolarity were not significantly different between the verum and control groups (p > 0.050). We conclude that for most patients with severe DED, 0.15% HMWHA eye drops provide excellent improvement of symptoms without impairment of dry eye signs.

Highlights

Dry eye disease (DED) is a multifactorial disorder affecting 5% to 35% of the world population [1]
The difference in corneal fluorescein staining (CFS) between baseline and week 8 determined by the masked reading center RC1 was the primary endpoint of the HYLAN M Study
Two patients reported during the week 4 visit about blurred vision for 10 min after the instillation of Comfort Shield eye drops, but they wanted to continue to participate in the study

Summary

Introduction

Dry eye disease (DED) is a multifactorial disorder affecting 5% to 35% of the world population [1]. In cases of severe DED, patients experience symptoms of ocular discomfort and visual instability, resulting in a considerable loss of quality of life. If ocular lubricants and secretagogues are not providing acceptable relief from symptoms, immunomodulatory eye drops such as cyclosporine may be tried [7] This treatment approach reflects the current model of pathophysiology of DED. Does nerve damage result in a reduction of trophic support for the corneal epithelium, it could initiate and maintain inflammation, and the interplay between nerve damage and inflammation needs to be taken into consideration [21,22] This might contribute to the well-known discordance between dry eye signs and symptoms [23,24,25,26]. Patients suffering from neuropathic ocular pain frequently respond poorly to treatment with lubricant eye drops [29,30]

Methods

Results

Discussion

Conclusion