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Safety and Tolerability of Overdosed Artificial Tears by Abraded Rabbit Corneas
Purpose: Preservative-free cationic emulsion-based artificial tear (AT) is an innovative eye drop based on the Novasorb(®) technology with cetalkonium chloride (CKC) as the cationic agent. The cationic emulsion Cationorm is designed for the management of mild-to-moderate dry eye disease (DED) patien...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Mary Ann Liebert, Inc., publishers
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6302909/ https://www.ncbi.nlm.nih.gov/pubmed/30312113 http://dx.doi.org/10.1089/jop.2018.0040 |
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author | Daull, Philippe Raymond, Elisabeth Feraille, Laurence Garrigue, Jean-Sébastien |
author_facet | Daull, Philippe Raymond, Elisabeth Feraille, Laurence Garrigue, Jean-Sébastien |
author_sort | Daull, Philippe |
collection | PubMed |
description | Purpose: Preservative-free cationic emulsion-based artificial tear (AT) is an innovative eye drop based on the Novasorb(®) technology with cetalkonium chloride (CKC) as the cationic agent. The cationic emulsion Cationorm is designed for the management of mild-to-moderate dry eye disease (DED) patients that present cornea epithelium alterations. The aim of the present study was to evaluate the safety and tolerability of overdosed ATs by altered corneal epithelium in vivo and assess the usefulness of the ex vivo eye irritation test (EVEIT) as a predictive alternate toxicity test method. Methods: The experimental procedure, treatment duration, and instillation frequency closely mimic in vivo the ex vivo protocol described by Pinheiro et al. and discussed in the Discussion and Conclusion section of this article. Two to 3-month-old female New Zealand white rabbits, n = 6 per group, were treated with ATs (21 instillations/day over 3 days) following corneal abrasion. Corneal fluorescein staining, in vivo confocal microscopy (IVCM), and slit lamp examinations were performed to assess corneal epithelium recovery and the ocular tolerability of the overdosed ATs. Results: All abraded eyes experienced almost complete epithelium recovery within 3 days following treatments with Cationorm, Optive, Vismed, and Saline. Benzalkonium chloride (BAK, 0.02%) treatment resulted in 82.4% reepithelialization. IVCM data illustrated corneal epithelium normal recovery. Acute local tolerability of the overdosed ATs was confirmed using Draize and McDonald–Shadduck's test scales. Conclusions: The different ATs were demonstrated to be well tolerated by abraded corneas in vivo, and the extreme overdosing regimen did not hamper the wound healing process of the rabbit eye in comparison to saline. These data did not confirm the ones obtained with the nonvalidated ex vivo eye irritation test. |
format | Online Article Text |
id | pubmed-6302909 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Mary Ann Liebert, Inc., publishers |
record_format | MEDLINE/PubMed |
spelling | pubmed-63029092018-12-26 Safety and Tolerability of Overdosed Artificial Tears by Abraded Rabbit Corneas Daull, Philippe Raymond, Elisabeth Feraille, Laurence Garrigue, Jean-Sébastien J Ocul Pharmacol Ther Original Articles Purpose: Preservative-free cationic emulsion-based artificial tear (AT) is an innovative eye drop based on the Novasorb(®) technology with cetalkonium chloride (CKC) as the cationic agent. The cationic emulsion Cationorm is designed for the management of mild-to-moderate dry eye disease (DED) patients that present cornea epithelium alterations. The aim of the present study was to evaluate the safety and tolerability of overdosed ATs by altered corneal epithelium in vivo and assess the usefulness of the ex vivo eye irritation test (EVEIT) as a predictive alternate toxicity test method. Methods: The experimental procedure, treatment duration, and instillation frequency closely mimic in vivo the ex vivo protocol described by Pinheiro et al. and discussed in the Discussion and Conclusion section of this article. Two to 3-month-old female New Zealand white rabbits, n = 6 per group, were treated with ATs (21 instillations/day over 3 days) following corneal abrasion. Corneal fluorescein staining, in vivo confocal microscopy (IVCM), and slit lamp examinations were performed to assess corneal epithelium recovery and the ocular tolerability of the overdosed ATs. Results: All abraded eyes experienced almost complete epithelium recovery within 3 days following treatments with Cationorm, Optive, Vismed, and Saline. Benzalkonium chloride (BAK, 0.02%) treatment resulted in 82.4% reepithelialization. IVCM data illustrated corneal epithelium normal recovery. Acute local tolerability of the overdosed ATs was confirmed using Draize and McDonald–Shadduck's test scales. Conclusions: The different ATs were demonstrated to be well tolerated by abraded corneas in vivo, and the extreme overdosing regimen did not hamper the wound healing process of the rabbit eye in comparison to saline. These data did not confirm the ones obtained with the nonvalidated ex vivo eye irritation test. Mary Ann Liebert, Inc., publishers 2018-12-01 2018-12-06 /pmc/articles/PMC6302909/ /pubmed/30312113 http://dx.doi.org/10.1089/jop.2018.0040 Text en © Philippe Daull et al. 2018; Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Articles Daull, Philippe Raymond, Elisabeth Feraille, Laurence Garrigue, Jean-Sébastien Safety and Tolerability of Overdosed Artificial Tears by Abraded Rabbit Corneas |
title | Safety and Tolerability of Overdosed Artificial Tears by Abraded Rabbit Corneas |
title_full | Safety and Tolerability of Overdosed Artificial Tears by Abraded Rabbit Corneas |
title_fullStr | Safety and Tolerability of Overdosed Artificial Tears by Abraded Rabbit Corneas |
title_full_unstemmed | Safety and Tolerability of Overdosed Artificial Tears by Abraded Rabbit Corneas |
title_short | Safety and Tolerability of Overdosed Artificial Tears by Abraded Rabbit Corneas |
title_sort | safety and tolerability of overdosed artificial tears by abraded rabbit corneas |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6302909/ https://www.ncbi.nlm.nih.gov/pubmed/30312113 http://dx.doi.org/10.1089/jop.2018.0040 |
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