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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...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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MDPI
2020
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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 |
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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 |
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