Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial

Steven Silverstein,1 Elizabeth Yeu,2 Joseph Tauber,3 Michel Guillon,4 Lyndon Jones,5,6 David Galarreta,7 Sruthi Srinivasan,8 Venkiteshwar Manoj8 1Silverstein Eye Centers, Kansas City, MO 64133, USA; 2Virginia Eye Consultants, Norfolk, VA 23502, USA; 3Tauber Eye Center, Kansas City, MO 64155, USA; 4O...

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Autores principales:	Silverstein S, Yeu E, Tauber J, Guillon M, Jones L, 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/ca2b898bb1eb4086804942dba0e48438
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spelling	oai:doaj.org-article:ca2b898bb1eb4086804942dba0e484382021-12-02T12:15:46ZSymptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial1177-5483https://doaj.org/article/ca2b898bb1eb4086804942dba0e484382020-10-01T00:00:00Zhttps://www.dovepress.com/symptom-relief-following-a-single-dose-of-propylene-glycol-hydroxyprop-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Steven Silverstein,1 Elizabeth Yeu,2 Joseph Tauber,3 Michel Guillon,4 Lyndon Jones,5,6 David Galarreta,7 Sruthi Srinivasan,8 Venkiteshwar Manoj8 1Silverstein Eye Centers, Kansas City, MO 64133, USA; 2Virginia Eye Consultants, Norfolk, VA 23502, USA; 3Tauber Eye Center, Kansas City, MO 64155, USA; 4Ocular Technology Group International, London SW1E 6AU, UK; 5Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, Waterloo, ON NL2 3G1, Canada; 6Centre for Eye and Vision Research Limited (CEVR), Hong Kong; 7Hospital Clinico Universitario de Valladolid, Valladolid Castilla y Leon 47011, Spain; 8Alcon Research, LLC, Johns Creek, GA, USACorrespondence: Steven SilversteinSilverstein Eye Centers, Kansas City, MO 64133, USATel +1 816.358.3600Fax +1 816.358.1887Email ssilverstein@silversteineyecenters.comPurpose: To evaluate symptom relief in patients with dry eye disease (DED) following a single drop of propylene glycol-hydroxypropyl guar (PG-HPG) nanoemulsion (Systane® Complete) lubricant eye drops.Methods: This was a Phase IV, multicenter, open-label, interventional study in adult patients with DED of aqueous-deficient, evaporative, and mixed subtypes. Patients instilled one drop of PG-HPG in each eye at Day 1. Endpoints included change from baseline in dry eye symptom and soothing sensation scores on Day 1 at 0, 4, and 8 hours post-dose. Symptom scores were assessed on a 0– 10 scale (0=no symptoms; 10=worst imaginable symptom). Tolerability of the drop was assessed based on assessment score on Day 1 following instillation for overall cohort and by DED subtype.Results: A total of 134 patients received treatment (mean age: 56.6 years; female: 75.4%). Median changes from baseline at Day 1 in dry eye symptom scores were − 1.0 (95% confidence interval [CI]:-3.0,-1.0), − 2.0 (95% CI:-3.0,-2.0), and − 2.0 (95% CI:-2.0,-1.0) at 0, 4, and 8 hours respectively. Subgroup analysis showed a median change from baseline in dry eye symptom score of − 2 (95% CI:-3.0,-1.0) for aqueous-deficient and evaporative subtypes and − 1 (95% CI:-3.0,-1.0) for mixed subtype at 8 hours. Median soothing sensation scores were 3 at 0 and 4 hours and 3.5 at 8 hours, with a range of 0– 10. Median (range) tolerability assessment scores were 0 (0– 8) for burning sensation, stinging sensation, blurring, and 0 (0– 10) for foreign body sensation. Tolerability assessment scores by DED subtype confirmed that the majority of patients reported scores in the range of 0– 5 for all components and in all subgroups analyzed.Conclusion: Our study demonstrated that PG-HPG nanoemulsion provided instant/immediate and sustained symptom relief for 8 hours post-single application and was well tolerated in patients with DED, demonstrated by their responses on each of the assessment scales.Keywords: aqueous-deficient dry eye, dry eye disease, evaporative dry eye, propylene glycol-hydroxypropyl guar nanoemulsion ocular lubricant, mixed dry eyeSilverstein SYeu ETauber JGuillon MJones LGalarreta 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 3167-3177 (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 Silverstein S Yeu E Tauber J Guillon M Jones L Galarreta D Srinivasan S Manoj V Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial
description	Steven Silverstein,1 Elizabeth Yeu,2 Joseph Tauber,3 Michel Guillon,4 Lyndon Jones,5,6 David Galarreta,7 Sruthi Srinivasan,8 Venkiteshwar Manoj8 1Silverstein Eye Centers, Kansas City, MO 64133, USA; 2Virginia Eye Consultants, Norfolk, VA 23502, USA; 3Tauber Eye Center, Kansas City, MO 64155, USA; 4Ocular Technology Group International, London SW1E 6AU, UK; 5Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, Waterloo, ON NL2 3G1, Canada; 6Centre for Eye and Vision Research Limited (CEVR), Hong Kong; 7Hospital Clinico Universitario de Valladolid, Valladolid Castilla y Leon 47011, Spain; 8Alcon Research, LLC, Johns Creek, GA, USACorrespondence: Steven SilversteinSilverstein Eye Centers, Kansas City, MO 64133, USATel +1 816.358.3600Fax +1 816.358.1887Email ssilverstein@silversteineyecenters.comPurpose: To evaluate symptom relief in patients with dry eye disease (DED) following a single drop of propylene glycol-hydroxypropyl guar (PG-HPG) nanoemulsion (Systane® Complete) lubricant eye drops.Methods: This was a Phase IV, multicenter, open-label, interventional study in adult patients with DED of aqueous-deficient, evaporative, and mixed subtypes. Patients instilled one drop of PG-HPG in each eye at Day 1. Endpoints included change from baseline in dry eye symptom and soothing sensation scores on Day 1 at 0, 4, and 8 hours post-dose. Symptom scores were assessed on a 0– 10 scale (0=no symptoms; 10=worst imaginable symptom). Tolerability of the drop was assessed based on assessment score on Day 1 following instillation for overall cohort and by DED subtype.Results: A total of 134 patients received treatment (mean age: 56.6 years; female: 75.4%). Median changes from baseline at Day 1 in dry eye symptom scores were − 1.0 (95% confidence interval [CI]:-3.0,-1.0), − 2.0 (95% CI:-3.0,-2.0), and − 2.0 (95% CI:-2.0,-1.0) at 0, 4, and 8 hours respectively. Subgroup analysis showed a median change from baseline in dry eye symptom score of − 2 (95% CI:-3.0,-1.0) for aqueous-deficient and evaporative subtypes and − 1 (95% CI:-3.0,-1.0) for mixed subtype at 8 hours. Median soothing sensation scores were 3 at 0 and 4 hours and 3.5 at 8 hours, with a range of 0– 10. Median (range) tolerability assessment scores were 0 (0– 8) for burning sensation, stinging sensation, blurring, and 0 (0– 10) for foreign body sensation. Tolerability assessment scores by DED subtype confirmed that the majority of patients reported scores in the range of 0– 5 for all components and in all subgroups analyzed.Conclusion: Our study demonstrated that PG-HPG nanoemulsion provided instant/immediate and sustained symptom relief for 8 hours post-single application and was well tolerated in patients with DED, demonstrated by their responses on each of the assessment scales.Keywords: aqueous-deficient dry eye, dry eye disease, evaporative dry eye, propylene glycol-hydroxypropyl guar nanoemulsion ocular lubricant, mixed dry eye
format	article
author	Silverstein S Yeu E Tauber J Guillon M Jones L Galarreta D Srinivasan S Manoj V
author_facet	Silverstein S Yeu E Tauber J Guillon M Jones L Galarreta D Srinivasan S Manoj V
author_sort	Silverstein S
title	Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial
title_short	Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial
title_full	Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial
title_fullStr	Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial
title_full_unstemmed	Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial
title_sort	symptom relief following a single dose of propylene glycol-hydroxypropyl guar nanoemulsion in patients with dry eye disease: a phase iv, multicenter trial
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/ca2b898bb1eb4086804942dba0e48438
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Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial

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