Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system

William Reindel, Mohinder M Merchea, Marjorie J Rah, Lening Zhang Bausch & Lomb Incorporated, Rochester, NY, USA Background: The purpose of this paper is to evaluate the biocompatibility of a novel multipurpose solution (MPS) with a dual disinfectant system containing polyaminopropyl biguani...

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Autores principales:	Reindel W, Merchea MM, Rah MJ, Zhang L
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/db20b1e544b44b2f9796261bb1a9f824
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spelling	oai:doaj.org-article:db20b1e544b44b2f9796261bb1a9f8242021-12-02T07:36:58ZMeta-analysis of the ocular biocompatibility of a new multipurpose lens care system1177-54671177-5483https://doaj.org/article/db20b1e544b44b2f9796261bb1a9f8242013-10-01T00:00:00Zhttp://www.dovepress.com/meta-analysis-of-the-ocular-biocompatibility-of-a-new-multipurpose-len-a14682https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483William Reindel, Mohinder M Merchea, Marjorie J Rah, Lening Zhang Bausch & Lomb Incorporated, Rochester, NY, USA Background: The purpose of this paper is to evaluate the biocompatibility of a novel multipurpose solution (MPS) with a dual disinfectant system containing polyaminopropyl biguanide and polyquaternium-1 (Biotrue®) by analysis of biomicroscopy signs and adverse events in six large clinical trials. Methods: Data from six consecutive, prospective clinical trials conducted from February 2008 to March 2010 were combined for meta-analysis. Subjects used the new MPS daily for periods of 2 weeks to 6 months. Slit-lamp signs were graded at each follow-up visit using an ordinal scale (0, one; 1, trace; 2, mild; 3, moderate; 4, severe). Analysis for biocompatibility included tracking of greater than grade 2 slit-lamp findings and number of adverse events. Results: A total of 1,567 subjects (3,134 eyes) and 81 clinical investigators participated in the six studies, with 1,499 subjects completing the studies. Based on subject days in the studies, there were 72,904 exposures to the MPS and 7,212 biomicroscopy examinations. The completion rate for the studies was 96.3%. Per observation incidence of any finding greater than grade 2 at the follow-up visits were: corneal staining 0.08%, limbal injection 0.04%, bulbar injection 0.04%, tarsal conjunctiva abnormality 0.09%, and neovascularization 0.01%. There were no other slit-lamp signs greater than grade 2 and no statistically significant difference between hydrogels and silicone hydrogels for any finding. There were no reports of adverse events during the trials. Conclusion: Analysis of over 72,000 daily exposures and 7,212 eye examinations showed that the novel MPS exhibited excellent biocompatibility in subjects using daily wear hydrogel or silicone hydrogel lenses. Keywords: contact lens, solutions, disinfection, meta-analysis, silicone, hydrogelReindel WMerchea MMRah MJZhang LDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2013, Iss default, Pp 2051-2056 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Reindel W Merchea MM Rah MJ Zhang L Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system
description	William Reindel, Mohinder M Merchea, Marjorie J Rah, Lening Zhang Bausch & Lomb Incorporated, Rochester, NY, USA Background: The purpose of this paper is to evaluate the biocompatibility of a novel multipurpose solution (MPS) with a dual disinfectant system containing polyaminopropyl biguanide and polyquaternium-1 (Biotrue®) by analysis of biomicroscopy signs and adverse events in six large clinical trials. Methods: Data from six consecutive, prospective clinical trials conducted from February 2008 to March 2010 were combined for meta-analysis. Subjects used the new MPS daily for periods of 2 weeks to 6 months. Slit-lamp signs were graded at each follow-up visit using an ordinal scale (0, one; 1, trace; 2, mild; 3, moderate; 4, severe). Analysis for biocompatibility included tracking of greater than grade 2 slit-lamp findings and number of adverse events. Results: A total of 1,567 subjects (3,134 eyes) and 81 clinical investigators participated in the six studies, with 1,499 subjects completing the studies. Based on subject days in the studies, there were 72,904 exposures to the MPS and 7,212 biomicroscopy examinations. The completion rate for the studies was 96.3%. Per observation incidence of any finding greater than grade 2 at the follow-up visits were: corneal staining 0.08%, limbal injection 0.04%, bulbar injection 0.04%, tarsal conjunctiva abnormality 0.09%, and neovascularization 0.01%. There were no other slit-lamp signs greater than grade 2 and no statistically significant difference between hydrogels and silicone hydrogels for any finding. There were no reports of adverse events during the trials. Conclusion: Analysis of over 72,000 daily exposures and 7,212 eye examinations showed that the novel MPS exhibited excellent biocompatibility in subjects using daily wear hydrogel or silicone hydrogel lenses. Keywords: contact lens, solutions, disinfection, meta-analysis, silicone, hydrogel
format	article
author	Reindel W Merchea MM Rah MJ Zhang L
author_facet	Reindel W Merchea MM Rah MJ Zhang L
author_sort	Reindel W
title	Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system
title_short	Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system
title_full	Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system
title_fullStr	Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system
title_full_unstemmed	Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system
title_sort	meta-analysis of the ocular biocompatibility of a new multipurpose lens care system
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/db20b1e544b44b2f9796261bb1a9f824
work_keys_str_mv	AT reindelw metaanalysisoftheocularbiocompatibilityofanewmultipurposelenscaresystem AT mercheamm metaanalysisoftheocularbiocompatibilityofanewmultipurposelenscaresystem AT rahmj metaanalysisoftheocularbiocompatibilityofanewmultipurposelenscaresystem AT zhangl metaanalysisoftheocularbiocompatibilityofanewmultipurposelenscaresystem
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Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system

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