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Article

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

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Karolinska Institutet, Department of Clinical Neuroscience, St. Eriks Eye Hospital, 11282 Stockholm, Sweden
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Quinze-Vingts National Eye Hospital & Vision Institute, IHU Foresight, 75571 Paris, France
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Department of Ophthalmology, Medical University Graz, 8036 Graz, Austria
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Eye Center, University Eye Hospital Freiburg and Medical Faculty, Albert Ludwigs University, 79106 Freiburg, Germany
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Department of Ophthalmology, University Medical Center Rostock, 18057 Rostock, Germany
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Department of Ophthalmology, Marmara University School of Medicine, 34899 Istanbul, Turkey
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Department of Ophthalmology, PSMMC Prince Sultan Military Medical City, MSD Medical Services Department, MODA Ministry of Defense and Aviation, Riyadh 12233, Saudi Arabia
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Universidad Complutense de Madrid, Hospital Clinico San Carlos, Clinica Rementeria, 28040 Madrid, Spain
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KKESH–King Khaled Eye Specialist Hospital, Riyadh 11462, Saudi Arabia
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Department of Ophthalmology, Saarland University Medical Center, 66421 Homburg/Saar, Germany
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Ocular Surface & Dry Eye Center, Ospedale L. Sacco, University of Milan, 20157 Milan, Italy
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Department of Ophthalmology & Department of Experimental Ophthalmology and Glaucoma Research, University Clinic Salzburg, Paracelsus Medical University, 5020 Salzburg, Austria
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CORONIS GmbH, 81241 Munich, Germany
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2020, 9(11), 3536; https://doi.org/10.3390/jcm9113536
Received: 3 October 2020 / Revised: 23 October 2020 / Accepted: 31 October 2020 / Published: 2 November 2020
(This article belongs to the Special Issue Cutting-Edge Topics in Dry Eye Disease)
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. View Full-Text
Keywords: dry eye disease; severe keratitis; hyaluronan; hylan A; multicenter; randomized trial dry eye disease; severe keratitis; hyaluronan; hylan A; multicenter; randomized trial
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MDPI and ACS Style

van Setten, G.-B.; Baudouin, C.; Horwath-Winter, J.; Böhringer, D.; Stachs, O.; Toker, E.; Al-Zaaidi, S.; Benitez-del-Castillo, J.M.; Beck, R.; Al-Sheikh, O.; Seitz, B.; Barabino, S.; Reitsamer, H.A.; Müller-Lierheim, W.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. J. Clin. Med. 2020, 9, 3536. https://doi.org/10.3390/jcm9113536

AMA Style

van Setten G-B, Baudouin C, Horwath-Winter J, Böhringer D, Stachs O, Toker E, Al-Zaaidi S, Benitez-del-Castillo JM, Beck R, Al-Sheikh O, Seitz B, Barabino S, Reitsamer HA, Müller-Lierheim WGK. 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. Journal of Clinical Medicine. 2020; 9(11):3536. https://doi.org/10.3390/jcm9113536

Chicago/Turabian Style

van Setten, Gysbert-Botho, Christophe Baudouin, Jutta Horwath-Winter, Daniel Böhringer, Oliver Stachs, Ebru Toker, Sultan Al-Zaaidi, Jose M. Benitez-del-Castillo, Ria Beck, Osama Al-Sheikh, Berthold Seitz, Stefano Barabino, Herbert A. Reitsamer, and Wolfgang G.K. Müller-Lierheim. 2020. "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" Journal of Clinical Medicine 9, no. 11: 3536. https://doi.org/10.3390/jcm9113536

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