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

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

Reflections on the ocular surface: Summary of the presentations at the 4th Coronis Foundation Ophthalmic Symposium Debate: “A multifactorial approach to ocular surface disorders” (August 31 2021)

The author (van Setten) thanks the Karin Sandqvists Foundation (Karin Sandqvists Stiftelse) Stockholm, Sweden, the Eye Foundation (Ögonfonden), Stockholm, Sweden and the Crown Princess Margaretas Foundation Working committee for the visually impaired KMA (Stiftelsen Kronprinsessan Margaretas Arbetsnämnd för synskadade KMA) Stockholm, Sweden, for the funding received forming the base for the presented model of dry eye disease.Peer reviewe