{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T08:12:36Z","timestamp":1777450356929,"version":"3.51.4"},"reference-count":28,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2024,8,21]],"date-time":"2024-08-21T00:00:00Z","timestamp":1724198400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006109","name":"VEGA","doi-asserted-by":"crossref","award":["2\/0153\/20"],"award-info":[{"award-number":["2\/0153\/20"]}],"id":[{"id":"10.13039\/501100006109","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100005357","name":"APVV","doi-asserted-by":"crossref","award":["APVV-19-0591"],"award-info":[{"award-number":["APVV-19-0591"]}],"id":[{"id":"10.13039\/501100005357","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Altern Lab Anim"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:p>This study introduces a novel in vitro methodology that employs the 3-D reconstructed tissue model, EpiOcular, to assess the irritation and phototoxicity potential of medical devices and drugs in contact with the eye. Our study evaluated diverse test materials, including medical devices, ophthalmological solutions and an experimental drug (cemtirestat), for their potential to cause eye irritation and phototoxicity. The protocols used in this study with the EpiOcular tissue model were akin to those used in the ultra-mildness testing of cosmetic formulations, which is challenging to predict with standard in vivo rabbit tests. To design these protocols, we leveraged experience gained from the validation project on the EpiDerm skin irritation test for medical devices (ISO 10993-23:2021) and the OECD TG 498 method for photo-irritation testing. The predictions were based on the tissue viability and inflammatory response, as determined by IL-1\u03b1 release. By developing and evaluating these protocols for medical devices, we aimed to expand the applicability domain of the tests referred to in ISO 10993-23. This will contribute to the standardisation and cost-effective safety evaluation of ophthalmic products, while reducing reliance on animal testing in this field. The findings obtained from the EpiOcular model in the photo-irritation test could support its implementation in the testing strategies outlined in OECD TG 498.<\/jats:p>","DOI":"10.1177\/02611929241270095","type":"journal-article","created":{"date-parts":[[2024,8,21]],"date-time":"2024-08-21T20:52:07Z","timestamp":1724273527000},"page":"261-275","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Development of Sensitive\n                    <i>In Vitro<\/i>\n                    Protocols for the Biocompatibility Testing of Medical Devices and Pharmaceuticals Intended for Contact with the Eyes: Acute Irritation and Phototoxicity Assessment"],"prefix":"10.1177","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8792-422X","authenticated-orcid":false,"given":"Peter","family":"P\u00f4bi\u0161","sequence":"first","affiliation":[{"name":"Institute of Experimental Pharmacology and Toxicology (IEPT), Centre of Experimental Medicine (CEM), Slovak Academy of Sciences (SAS), Bratislava, Slovakia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00falia","family":"Kubalcov\u00e1","sequence":"additional","affiliation":[{"name":"Institute of Biochemistry and Microbiology, Faculty of Chemical and Food Technology, Slovak University of Technology in Bratislava, Bratislava, Slovakia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatiana","family":"Milasov\u00e1","sequence":"additional","affiliation":[{"name":"Institute of Experimental Pharmacology and Toxicology (IEPT), Centre of Experimental Medicine (CEM), Slovak Academy of Sciences (SAS), Bratislava, Slovakia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6926-1343","authenticated-orcid":false,"given":"Helena","family":"Kand\u00e1rov\u00e1","sequence":"additional","affiliation":[{"name":"Institute of Experimental Pharmacology and Toxicology (IEPT), Centre of Experimental Medicine (CEM), Slovak Academy of Sciences (SAS), Bratislava, Slovakia"},{"name":"Institute of Biochemistry and Microbiology, Faculty of Chemical and Food Technology, Slovak University of Technology in Bratislava, Bratislava, Slovakia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2024,8,21]]},"reference":[{"key":"bibr1-02611929241270095","first-page":"1","volume":"5","author":"Kand\u00e1rov\u00e1 H","year":"2023","journal-title":"Front Toxicol"},{"key":"bibr2-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1016\/j.tiv.2018.01.001"},{"key":"bibr3-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1016\/j.tiv.2018.02.007"},{"key":"bibr4-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1787\/7b2f9ea0-en"},{"key":"bibr5-02611929241270095","unstructured":"ISO. ISO 10993-12:2021. Biological evaluation of medical devices, Part 12: Sample preparation and reference materials. Geneva: International Organization for Standardization, 2021, 21 pp."},{"key":"bibr6-02611929241270095","doi-asserted-by":"publisher","DOI":"10.3791\/52979-v"},{"key":"bibr7-02611929241270095","unstructured":"OECD. Test No. 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage. OECD Guidelines for the Testing of Chemicals, Section 4. Paris: OECD Publishing, 2024, 40 pp."},{"key":"bibr8-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1016\/j.tiv.2017.07.002"},{"key":"bibr9-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2023.103676"},{"key":"bibr10-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1021\/acsbiomaterials.8b00582"},{"key":"bibr11-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1016\/j.pdpdt.2019.04.019"},{"key":"bibr12-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1002\/jbm.a.30953"},{"key":"bibr13-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuroscience.2020.07.014"},{"key":"bibr14-02611929241270095","first-page":"872","volume":"56","author":"Alexander LJ","year":"1985","journal-title":"J Am Optom Assoc"},{"key":"bibr15-02611929241270095","first-page":"132","volume-title":"Alternative toxicological methods","author":"Klausner M","year":"2003"},{"key":"bibr16-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1016\/S0887-2333(98)00017-4"},{"key":"bibr17-02611929241270095","first-page":"243","volume":"66","author":"McCain NE","year":"2002","journal-title":"The Toxicologist"},{"key":"bibr18-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1016\/j.tiv.2018.02.009"},{"key":"bibr19-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1016\/j.autrev.2021.102763"},{"key":"bibr20-02611929241270095","doi-asserted-by":"publisher","DOI":"10.14573\/altex.1997.4.165"},{"key":"bibr21-02611929241270095","first-page":"160","volume-title":"Alternatives to Animal Testing II: Proceedings of the second international scientific conference organised by the European Cosmetic Industry. Brussels, Belgium, 1999","author":"Liebsch M","year":"1999"},{"key":"bibr22-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-319-50353-0_35"},{"key":"bibr23-02611929241270095","first-page":"441","volume":"37","author":"L\u00ed\u0161kov\u00e1 A","year":"2020","journal-title":"ALTEX"},{"key":"bibr24-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1787\/9789264071162-en"},{"key":"bibr25-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1016\/j.tiv.2018.01.018"},{"key":"bibr26-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1177\/026119291103900409"},{"key":"bibr27-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1016\/j.tiv.2022.105319"},{"key":"bibr28-02611929241270095","doi-asserted-by":"publisher","DOI":"10.1016\/j.yrtph.2019.04.022"}],"container-title":["Alternatives to Laboratory Animals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/02611929241270095","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/02611929241270095","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/02611929241270095","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:43:18Z","timestamp":1777380198000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/02611929241270095"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8,21]]},"references-count":28,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,9]]}},"alternative-id":["10.1177\/02611929241270095"],"URL":"https:\/\/doi.org\/10.1177\/02611929241270095","relation":{},"ISSN":["0261-1929","2632-3559"],"issn-type":[{"value":"0261-1929","type":"print"},{"value":"2632-3559","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8,21]]}}}