Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial

Elizabeth Yeu,1 Steven Silverstein,2 Michel Guillon,3 Marc-Matthias Schulze,4 David Galarreta,5 Sruthi Srinivasan,6 Venkiteshwar Manoj6 1Virginia Eye Consultants, Norfolk, VA 23502, USA; 2Silverstein Eye Centers, Kansas City, MO 64133, USA; 3Ocular Technology Group International, London SW1E 6AU, UK...

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Autores principales:	Yeu E, Silverstein S, Guillon M, Schulze MM, Galarreta D, Srinivasan S, Manoj V
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	aqueous deficient dry eye dry eye disease evaporative dry eye propylene glycol/hydroxypropyl guar-nanoemulsion ocular lubricant mixed dry eye Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/c30e0786e33c4d28a349b8a8f761a384
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spelling	oai:doaj.org-article:c30e0786e33c4d28a349b8a8f761a3842021-12-02T10:20:12ZEfficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial1177-5483https://doaj.org/article/c30e0786e33c4d28a349b8a8f761a3842020-09-01T00:00:00Zhttps://www.dovepress.com/efficacy-and-safety-of-phospholipid-nanoemulsion-based-ocular-lubrican-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Elizabeth Yeu,1 Steven Silverstein,2 Michel Guillon,3 Marc-Matthias Schulze,4 David Galarreta,5 Sruthi Srinivasan,6 Venkiteshwar Manoj6 1Virginia Eye Consultants, Norfolk, VA 23502, USA; 2Silverstein Eye Centers, Kansas City, MO 64133, USA; 3Ocular Technology Group International, London SW1E 6AU, UK; 4Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario NL2 3G1, Canada; 5Hospital Clinico Universitario de Valladolid, Valladolid Castillay Leon 47011, Spain; 6Alcon Research, LLC, Johns Creek, GA 30097, USACorrespondence: Elizabeth YeuVirginia Eye Consultants, Norfolk, VA 23502, USATel +1 757-622-2200Fax +1 757-961-0011Email eyeu@vec2020.comPurpose: To evaluate the clinical efficacy and safety of propylene glycol/hydroxypropyl-guar (PG-HPG)-based nanoemulsion (Systane® Complete) lubricant eye drops in participants with dry eye disease (DED).Participants and Methods: In this phase IV, open-label, single-arm, interventional, multicenter study, adult participants with DED – subtyped into aqueous deficient, evaporative, and mixed dry eye – were instructed to instill one drop of PG-HPG in each eye twice a day for 28 days. Endpoints included change from baseline in tear film break-up time (TFBUT) (primary) and ocular discomfort visual analog scale (VAS) score at Day 14 and TFBUT at Day 28 (secondary). Safety was assessed throughout the study. Data were analyzed for overall patient cohort and by DED subtypes.Results: A total of 134 participants received treatment (mean age: 56.6 years; female: 75.4%). At Day 14, the mean (standard deviation [SD]) TFBUT increased from 2.6 (1.00) seconds at baseline to 4.2 (2.92) seconds (mean change: 1.5 [2.80] seconds); median change was 0.8 seconds (95% CI: 0.52, 1.19) for the overall cohort; the change was maintained at Day 28 (mean change: 1.4 (2.80) seconds, median change: 0.8 seconds (95% CI: 0.49, 1.17). Subgroup analysis showed a mean change (SD) from baseline in TFBUT of 1.1 (2.41) seconds for aqueous deficient, 2.4 (3.17) seconds for evaporative, and 1.2 (2.63) seconds for mixed dry eye at Day 14, respectively. The ocular discomfort VAS score improved (decreased) from baseline at Day 14 (mean [SD] change: − 17.3 [24.80]) for the overall cohort, − 22.0 [21.73] for aqueous deficient, − 17.6 [24.17] for evaporative and − 13.1 [27.49] for mixed dry eye subgroups). Adverse events (AEs) were reported in 9 (6.7%) participants. No serious AEs were reported during the study.Conclusion: Our study findings demonstrated that PG-HPG-based nanoemulsion lubricant eye drops were effective and well tolerated in participants with DED and all of its subtypes.Keywords: aqueous deficient dry eye, dry eye disease, evaporative dry eye, propylene glycol/hydroxypropyl guar-nanoemulsion ocular lubricant, mixed dry eyeYeu ESilverstein SGuillon MSchulze MMGalarreta DSrinivasan SManoj VDove Medical Pressarticleaqueous deficient dry eyedry eye diseaseevaporative dry eyepropylene glycol/hydroxypropyl guar-nanoemulsion ocular lubricantmixed dry eyeOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 14, Pp 2561-2570 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	aqueous deficient dry eye dry eye disease evaporative dry eye propylene glycol/hydroxypropyl guar-nanoemulsion ocular lubricant mixed dry eye Ophthalmology RE1-994
spellingShingle	aqueous deficient dry eye dry eye disease evaporative dry eye propylene glycol/hydroxypropyl guar-nanoemulsion ocular lubricant mixed dry eye Ophthalmology RE1-994 Yeu E Silverstein S Guillon M Schulze MM Galarreta D Srinivasan S Manoj V Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial
description	Elizabeth Yeu,1 Steven Silverstein,2 Michel Guillon,3 Marc-Matthias Schulze,4 David Galarreta,5 Sruthi Srinivasan,6 Venkiteshwar Manoj6 1Virginia Eye Consultants, Norfolk, VA 23502, USA; 2Silverstein Eye Centers, Kansas City, MO 64133, USA; 3Ocular Technology Group International, London SW1E 6AU, UK; 4Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario NL2 3G1, Canada; 5Hospital Clinico Universitario de Valladolid, Valladolid Castillay Leon 47011, Spain; 6Alcon Research, LLC, Johns Creek, GA 30097, USACorrespondence: Elizabeth YeuVirginia Eye Consultants, Norfolk, VA 23502, USATel +1 757-622-2200Fax +1 757-961-0011Email eyeu@vec2020.comPurpose: To evaluate the clinical efficacy and safety of propylene glycol/hydroxypropyl-guar (PG-HPG)-based nanoemulsion (Systane® Complete) lubricant eye drops in participants with dry eye disease (DED).Participants and Methods: In this phase IV, open-label, single-arm, interventional, multicenter study, adult participants with DED – subtyped into aqueous deficient, evaporative, and mixed dry eye – were instructed to instill one drop of PG-HPG in each eye twice a day for 28 days. Endpoints included change from baseline in tear film break-up time (TFBUT) (primary) and ocular discomfort visual analog scale (VAS) score at Day 14 and TFBUT at Day 28 (secondary). Safety was assessed throughout the study. Data were analyzed for overall patient cohort and by DED subtypes.Results: A total of 134 participants received treatment (mean age: 56.6 years; female: 75.4%). At Day 14, the mean (standard deviation [SD]) TFBUT increased from 2.6 (1.00) seconds at baseline to 4.2 (2.92) seconds (mean change: 1.5 [2.80] seconds); median change was 0.8 seconds (95% CI: 0.52, 1.19) for the overall cohort; the change was maintained at Day 28 (mean change: 1.4 (2.80) seconds, median change: 0.8 seconds (95% CI: 0.49, 1.17). Subgroup analysis showed a mean change (SD) from baseline in TFBUT of 1.1 (2.41) seconds for aqueous deficient, 2.4 (3.17) seconds for evaporative, and 1.2 (2.63) seconds for mixed dry eye at Day 14, respectively. The ocular discomfort VAS score improved (decreased) from baseline at Day 14 (mean [SD] change: − 17.3 [24.80]) for the overall cohort, − 22.0 [21.73] for aqueous deficient, − 17.6 [24.17] for evaporative and − 13.1 [27.49] for mixed dry eye subgroups). Adverse events (AEs) were reported in 9 (6.7%) participants. No serious AEs were reported during the study.Conclusion: Our study findings demonstrated that PG-HPG-based nanoemulsion lubricant eye drops were effective and well tolerated in participants with DED and all of its subtypes.Keywords: aqueous deficient dry eye, dry eye disease, evaporative dry eye, propylene glycol/hydroxypropyl guar-nanoemulsion ocular lubricant, mixed dry eye
format	article
author	Yeu E Silverstein S Guillon M Schulze MM Galarreta D Srinivasan S Manoj V
author_facet	Yeu E Silverstein S Guillon M Schulze MM Galarreta D Srinivasan S Manoj V
author_sort	Yeu E
title	Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial
title_short	Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial
title_full	Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial
title_fullStr	Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial
title_full_unstemmed	Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial
title_sort	efficacy and safety of phospholipid nanoemulsion-based ocular lubricant for the management of various subtypes of dry eye disease: a phase iv, multicenter trial
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/c30e0786e33c4d28a349b8a8f761a384
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Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial

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