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Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system
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. ME...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove Medical Press
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3798238/ https://www.ncbi.nlm.nih.gov/pubmed/24143073 http://dx.doi.org/10.2147/OPTH.S48914 |
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author | Reindel, William Merchea, Mohinder M Rah, Marjorie J Zhang, Lening |
author_facet | Reindel, William Merchea, Mohinder M Rah, Marjorie J Zhang, Lening |
author_sort | Reindel, William |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-3798238 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-37982382013-10-18 Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system Reindel, William Merchea, Mohinder M Rah, Marjorie J Zhang, Lening Clin Ophthalmol Original Research 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. Dove Medical Press 2013 2013-10-14 /pmc/articles/PMC3798238/ /pubmed/24143073 http://dx.doi.org/10.2147/OPTH.S48914 Text en © 2013 Reindel et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Original Research Reindel, William Merchea, Mohinder M Rah, Marjorie J Zhang, Lening Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system |
title | 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_short | 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 |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3798238/ https://www.ncbi.nlm.nih.gov/pubmed/24143073 http://dx.doi.org/10.2147/OPTH.S48914 |
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