Cargando…

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 st...

Descripción completa

Detalles Bibliográficos
Autores principales: van Setten, Gysbert-Botho, Baudouin, Christophe, Horwath-Winter, Jutta, Böhringer, Daniel, Stachs, Oliver, Toker, Ebru, Al-Zaaidi, Sultan, Benitez-del-Castillo, Jose M., Beck, Ria, Al-Sheikh, Osama, Seitz, Berthold, Barabino, Stefano, Reitsamer, Herbert A., Müller-Lierheim, Wolfgang G.K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7693312/
https://www.ncbi.nlm.nih.gov/pubmed/33147751
http://dx.doi.org/10.3390/jcm9113536
_version_ 1783614715140767744
author van Setten, Gysbert-Botho
Baudouin, Christophe
Horwath-Winter, Jutta
Böhringer, Daniel
Stachs, Oliver
Toker, Ebru
Al-Zaaidi, Sultan
Benitez-del-Castillo, Jose M.
Beck, Ria
Al-Sheikh, Osama
Seitz, Berthold
Barabino, Stefano
Reitsamer, Herbert A.
Müller-Lierheim, Wolfgang G.K.
author_facet van Setten, Gysbert-Botho
Baudouin, Christophe
Horwath-Winter, Jutta
Böhringer, Daniel
Stachs, Oliver
Toker, Ebru
Al-Zaaidi, Sultan
Benitez-del-Castillo, Jose M.
Beck, Ria
Al-Sheikh, Osama
Seitz, Berthold
Barabino, Stefano
Reitsamer, Herbert A.
Müller-Lierheim, Wolfgang G.K.
author_sort van Setten, Gysbert-Botho
collection PubMed
description 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.
format Online
Article
Text
id pubmed-7693312
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-76933122020-11-28 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 van Setten, Gysbert-Botho Baudouin, Christophe Horwath-Winter, Jutta Böhringer, Daniel Stachs, Oliver Toker, Ebru Al-Zaaidi, Sultan Benitez-del-Castillo, Jose M. Beck, Ria Al-Sheikh, Osama Seitz, Berthold Barabino, Stefano Reitsamer, Herbert A. Müller-Lierheim, Wolfgang G.K. J Clin Med Article 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. MDPI 2020-11-02 /pmc/articles/PMC7693312/ /pubmed/33147751 http://dx.doi.org/10.3390/jcm9113536 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
van Setten, Gysbert-Botho
Baudouin, Christophe
Horwath-Winter, Jutta
Böhringer, Daniel
Stachs, Oliver
Toker, Ebru
Al-Zaaidi, Sultan
Benitez-del-Castillo, Jose M.
Beck, Ria
Al-Sheikh, Osama
Seitz, Berthold
Barabino, Stefano
Reitsamer, Herbert A.
Müller-Lierheim, Wolfgang G.K.
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7693312/
https://www.ncbi.nlm.nih.gov/pubmed/33147751
http://dx.doi.org/10.3390/jcm9113536
work_keys_str_mv AT vansettengysbertbotho thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT baudouinchristophe thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT horwathwinterjutta thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT bohringerdaniel thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT stachsoliver thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT tokerebru thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT alzaaidisultan thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT benitezdelcastillojosem thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT beckria thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT alsheikhosama thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT seitzberthold thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT barabinostefano thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT reitsamerherberta thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT mullerlierheimwolfganggk thehylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT vansettengysbertbotho hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT baudouinchristophe hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT horwathwinterjutta hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT bohringerdaniel hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT stachsoliver hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT tokerebru hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT alzaaidisultan hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT benitezdelcastillojosem hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT beckria hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT alsheikhosama hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT seitzberthold hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT barabinostefano hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT reitsamerherberta hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial
AT mullerlierheimwolfganggk hylanmstudyefficacyof015highmolecularweighthyaluronanfluidinthetreatmentofseveredryeyediseaseinamulticenterrandomizedtrial