Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis

William Reindel,1 Gary Mosehauer,1 Marjorie Rah,1 Howard Proskin,2 Robert Steffen1 1Vision Care, Bausch & Lomb Incorporated, Rochester, NY, USA; 2Howard M. Proskin & Associates, Rochester, NY, USACorrespondence: Marjorie RahVision Care, Bausch & Lomb Incorporated, Rochester,...

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Autores principales:	Reindel W, Mosehauer G, Rah M, Proskin H, Steffen R
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	pvp contact lens extended wear Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/d9c5027b034844208f7a14c7e0b88804
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spelling	oai:doaj.org-article:d9c5027b034844208f7a14c7e0b888042021-12-02T12:09:10ZClinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis1177-5483https://doaj.org/article/d9c5027b034844208f7a14c7e0b888042020-10-01T00:00:00Zhttps://www.dovepress.com/clinical-performance-of-samfilcon-a-a-unique-silicone-hydrogel-lens-on-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483William Reindel,1 Gary Mosehauer,1 Marjorie Rah,1 Howard Proskin,2 Robert Steffen1 1Vision Care, Bausch & Lomb Incorporated, Rochester, NY, USA; 2Howard M. Proskin & Associates, Rochester, NY, USACorrespondence: Marjorie RahVision Care, Bausch & Lomb Incorporated, Rochester, NY, USATel +1 585-413-6397Email Marjorie.Rah@bausch.comPurpose: The objective of this study was to evaluate and compare the clinical performance of samfilcon A, a unique, polyvinylpyrrolidone (PVP)-containing, silicone hydrogel contact lens with that of the balafilcon A silicone hydrogel contact lens when worn on a 7-day extended wear basis.Subjects and Methods: A total of 669 subjects completed this 12-month, controlled, parallel group, masked, randomized study; of these, 340 wore samfilcon A lenses and 329 balafilcon A lenses. Subjects wore their respective assigned lenses bilaterally on a 7-day extended wear basis. On the seventh night of each wearing week, lenses were removed, cleaned, and disinfected using Biotrue multi-purpose solution (MPS), then re-inserted the following morning. Lenses were replaced with new lenses monthly. At each follow-up visit, investigators completed a slit lamp evaluation, and subjects rated lenses based upon a predefined set of performance criteria.Results: The samfilcon A lens performed comparably to the balafilcon A lens in terms of most graded and ungraded slit lamp findings, differing significantly only for corneal staining Grade 2 or greater, which favored samfilcon A, and anterior segment abnormalities, which favored balafilcon A. Subjects rated both lenses highly when queried about various lens-wearing characteristics. When comparing the number of subjects with findings on either eye on at least one follow-up visit, the two lenses were comparable in many aspects but favored samfilcon A with respect to cleanliness upon removal, overall comfort, comfort at end of day, dryness, vision, vision in low light, vision at end of day, and overall impression (all p < 0.05).Conclusion: While subjects rated both highly, samfilcon A lenses worn for 7-day extended wear and replaced on a monthly basis performed comparably to or better than balafilcon A lenses when worn for the same 7-day wear time and replacement cycle.Keywords: PVP, contact lens, extended wearReindel WMosehauer GRah MProskin HSteffen RDove Medical Pressarticlepvpcontact lensextended wearOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 14, Pp 3457-3464 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	pvp contact lens extended wear Ophthalmology RE1-994
spellingShingle	pvp contact lens extended wear Ophthalmology RE1-994 Reindel W Mosehauer G Rah M Proskin H Steffen R Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis
description	William Reindel,1 Gary Mosehauer,1 Marjorie Rah,1 Howard Proskin,2 Robert Steffen1 1Vision Care, Bausch & Lomb Incorporated, Rochester, NY, USA; 2Howard M. Proskin & Associates, Rochester, NY, USACorrespondence: Marjorie RahVision Care, Bausch & Lomb Incorporated, Rochester, NY, USATel +1 585-413-6397Email Marjorie.Rah@bausch.comPurpose: The objective of this study was to evaluate and compare the clinical performance of samfilcon A, a unique, polyvinylpyrrolidone (PVP)-containing, silicone hydrogel contact lens with that of the balafilcon A silicone hydrogel contact lens when worn on a 7-day extended wear basis.Subjects and Methods: A total of 669 subjects completed this 12-month, controlled, parallel group, masked, randomized study; of these, 340 wore samfilcon A lenses and 329 balafilcon A lenses. Subjects wore their respective assigned lenses bilaterally on a 7-day extended wear basis. On the seventh night of each wearing week, lenses were removed, cleaned, and disinfected using Biotrue multi-purpose solution (MPS), then re-inserted the following morning. Lenses were replaced with new lenses monthly. At each follow-up visit, investigators completed a slit lamp evaluation, and subjects rated lenses based upon a predefined set of performance criteria.Results: The samfilcon A lens performed comparably to the balafilcon A lens in terms of most graded and ungraded slit lamp findings, differing significantly only for corneal staining Grade 2 or greater, which favored samfilcon A, and anterior segment abnormalities, which favored balafilcon A. Subjects rated both lenses highly when queried about various lens-wearing characteristics. When comparing the number of subjects with findings on either eye on at least one follow-up visit, the two lenses were comparable in many aspects but favored samfilcon A with respect to cleanliness upon removal, overall comfort, comfort at end of day, dryness, vision, vision in low light, vision at end of day, and overall impression (all p < 0.05).Conclusion: While subjects rated both highly, samfilcon A lenses worn for 7-day extended wear and replaced on a monthly basis performed comparably to or better than balafilcon A lenses when worn for the same 7-day wear time and replacement cycle.Keywords: PVP, contact lens, extended wear
format	article
author	Reindel W Mosehauer G Rah M Proskin H Steffen R
author_facet	Reindel W Mosehauer G Rah M Proskin H Steffen R
author_sort	Reindel W
title	Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis
title_short	Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis
title_full	Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis
title_fullStr	Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis
title_full_unstemmed	Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis
title_sort	clinical performance of samfilcon a, a unique silicone hydrogel lens, on a 7-day extended wear basis
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/d9c5027b034844208f7a14c7e0b88804
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Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis

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