Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study

Marc Labetoulle,1 Stefanie Schmickler,2 David Galarreta,3 Daniel Böhringer,4 Abayomi Ogundele,5 Michel Guillon,6 Christophe Baudouin7,8 1Ophtalmologie, Hôpital Bicêtre, APHP, South Paris Université, Kremlin-Bicêtre, Paris, France; 2Augen-Zentrum-Nor...

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Autores principales:	Labetoulle M, Schmickler S, Galarreta D, Böhringer D, Ogundele A, Guillon M, Baudouin C
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	dry eye disease dual polymer artificial tears hydroxypropyl guar hyaluronic acid Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/4a96c66229bb484295da320ca3d90d8e
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spelling	oai:doaj.org-article:4a96c66229bb484295da320ca3d90d8e2021-12-02T04:01:37ZEfficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study1177-5483https://doaj.org/article/4a96c66229bb484295da320ca3d90d8e2018-12-01T00:00:00Zhttps://www.dovepress.com/efficacy-and-safety-of-dual-polymer-hydroxypropyl-guar--and-hyaluronic-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Marc Labetoulle,1 Stefanie Schmickler,2 David Galarreta,3 Daniel Böhringer,4 Abayomi Ogundele,5 Michel Guillon,6 Christophe Baudouin7,8 1Ophtalmologie, Hôpital Bicêtre, APHP, South Paris Université, Kremlin-Bicêtre, Paris, France; 2Augen-Zentrum-Nordwest Augenpraxis, Ahaus, Germany; 3Hospital Clinico Universitario de Valladolid, Valladolid, Spain; 4Eye Center, University Hospital Freiburg, Freiburg, Germany; 5Novartis Pharmaceutical Corporation, Fort Worth, TX, USA; 6Ocular Technology Group, London, UK; 7Quinze-Vingts Hospital, DHU Sight Restore, University Versailles Saint Quentin en Yvelines, INSERM-DHOS CIC, Paris, France; 8Sorbonne Universités, UPMC Univ Paris 06, INSERM, CNRS, Institut de la Vision, Paris, France Background: An artificial-tear formulation containing the dual polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA) is approved for the treatment of dry-eye disease (DED). The present study compared the efficacy and safety of the HPG-HA dual-polymer formulation vs a sodium hyaluronate (SH)-containing artificial-tear formulation in patients with DED.Methods: In a prospective, 6-week, multicenter, double-masked, parallel-group study, patients with DED aged ≥18 years and total ocular surface staining (TOSS) score ≥4 and ≤9 were randomized (1:1) to receive either HPG-HA or SH four times a day for 42 days. Changes from baseline in TOSS (primary end point), impact of dry eye on everyday life (IDEEL) treatment-satisfaction scores (effectiveness and inconvenience), and tear-film breakup time (TFBUT) at day 42 were assessed using a fixed-sequence testing strategy. Noninferiority was assessed on the primary end point based on the upper limit of two-sided 95% CIs for mean treatment difference (HPG-HA or SH) <2 units.Results: In total, 99 patients were randomized (HPG-HA, n= 50; SH, n= 49). At day 42, the least square (LS) mean ± SE change from baseline in TOSS was -1.16±0.24 and -0.92±0.23 in the HPG-HA and SH groups, respectively, and the treatment difference was -0.24±0.33 (95% CI -0.90 to 0.42). Noninferiority was demonstrated as the upper limit of the 95% CI was <2 units. LS mean change from baseline at day 42 for HPG-HA vs SH was -3.18 (P=0.4817) in IDEEL treatment-effectiveness scores, -12.56 (P=0.0001) in treatment-inconvenience scores, and 0.30 seconds (P=0.5789) in TFBUT.Conclusion: The HPG-HA dual-polymer formulation was noninferior to the SH lubricant eyedrops for improvement in ocular surface staining in DED. HPG-HA did not show improvement over SH in IDEEL treatment-satisfaction scores. No new safety findings were reported. Keywords: dry-eye disease, dual polymer, artificial tears, hydroxypropyl guar, hyaluronic acid Labetoulle MSchmickler SGalarreta DBöhringer DOgundele AGuillon MBaudouin CDove Medical Pressarticledry eye diseasedual polymerartificial tearshydroxypropyl guarhyaluronic acidOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 12, Pp 2499-2508 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	dry eye disease dual polymer artificial tears hydroxypropyl guar hyaluronic acid Ophthalmology RE1-994
spellingShingle	dry eye disease dual polymer artificial tears hydroxypropyl guar hyaluronic acid Ophthalmology RE1-994 Labetoulle M Schmickler S Galarreta D Böhringer D Ogundele A Guillon M Baudouin C Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study
description	Marc Labetoulle,1 Stefanie Schmickler,2 David Galarreta,3 Daniel Böhringer,4 Abayomi Ogundele,5 Michel Guillon,6 Christophe Baudouin7,8 1Ophtalmologie, Hôpital Bicêtre, APHP, South Paris Université, Kremlin-Bicêtre, Paris, France; 2Augen-Zentrum-Nordwest Augenpraxis, Ahaus, Germany; 3Hospital Clinico Universitario de Valladolid, Valladolid, Spain; 4Eye Center, University Hospital Freiburg, Freiburg, Germany; 5Novartis Pharmaceutical Corporation, Fort Worth, TX, USA; 6Ocular Technology Group, London, UK; 7Quinze-Vingts Hospital, DHU Sight Restore, University Versailles Saint Quentin en Yvelines, INSERM-DHOS CIC, Paris, France; 8Sorbonne Universités, UPMC Univ Paris 06, INSERM, CNRS, Institut de la Vision, Paris, France Background: An artificial-tear formulation containing the dual polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA) is approved for the treatment of dry-eye disease (DED). The present study compared the efficacy and safety of the HPG-HA dual-polymer formulation vs a sodium hyaluronate (SH)-containing artificial-tear formulation in patients with DED.Methods: In a prospective, 6-week, multicenter, double-masked, parallel-group study, patients with DED aged ≥18 years and total ocular surface staining (TOSS) score ≥4 and ≤9 were randomized (1:1) to receive either HPG-HA or SH four times a day for 42 days. Changes from baseline in TOSS (primary end point), impact of dry eye on everyday life (IDEEL) treatment-satisfaction scores (effectiveness and inconvenience), and tear-film breakup time (TFBUT) at day 42 were assessed using a fixed-sequence testing strategy. Noninferiority was assessed on the primary end point based on the upper limit of two-sided 95% CIs for mean treatment difference (HPG-HA or SH) <2 units.Results: In total, 99 patients were randomized (HPG-HA, n= 50; SH, n= 49). At day 42, the least square (LS) mean ± SE change from baseline in TOSS was -1.16±0.24 and -0.92±0.23 in the HPG-HA and SH groups, respectively, and the treatment difference was -0.24±0.33 (95% CI -0.90 to 0.42). Noninferiority was demonstrated as the upper limit of the 95% CI was <2 units. LS mean change from baseline at day 42 for HPG-HA vs SH was -3.18 (P=0.4817) in IDEEL treatment-effectiveness scores, -12.56 (P=0.0001) in treatment-inconvenience scores, and 0.30 seconds (P=0.5789) in TFBUT.Conclusion: The HPG-HA dual-polymer formulation was noninferior to the SH lubricant eyedrops for improvement in ocular surface staining in DED. HPG-HA did not show improvement over SH in IDEEL treatment-satisfaction scores. No new safety findings were reported. Keywords: dry-eye disease, dual polymer, artificial tears, hydroxypropyl guar, hyaluronic acid
format	article
author	Labetoulle M Schmickler S Galarreta D Böhringer D Ogundele A Guillon M Baudouin C
author_facet	Labetoulle M Schmickler S Galarreta D Böhringer D Ogundele A Guillon M Baudouin C
author_sort	Labetoulle M
title	Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study
title_short	Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study
title_full	Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study
title_fullStr	Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study
title_full_unstemmed	Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study
title_sort	efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/4a96c66229bb484295da320ca3d90d8e
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Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study

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