Exploration and comparison of in vitro eye irritation tests with the ISO standard in vivo rabbit test for the evaluation of the ocular irritancy of contact lenses.pdfVIP

Toxicology in Vitro 37 (2016) 79–87 Contents lists available at ScienceDirect Toxicology in Vitro journal homepage: /locate/toxinvit Exploration and comparison of in vitro eye irritation tests with the ISO standard in vivo rabbit test for the evaluation of the ocular irritancy of contact lenses Jun-Won Yun a,1, Quan Hailian b,1, Yirang Na b, Byeong-Cheol Kang a, Jung-Hee Yoon a, Eun-Young Cho a, Miri Lee c, Da-eun Kim c, SeungJin Bae c, Seung Hyeok Seok b,?, Kyung-Min Lim c,?? a Department of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea b Department of Microbiology and Immunology, Institute of Endemic Disease, Seoul National University College of Medicine, Seoul, Republic of Korea c College of Pharmacology, Ewha Womans University, Seoul 120-808, Republic of Korea article info Article history: Received 1 March 2016 Received in revised form 10 July 2016 Accepted 1 September 2016 Available online 3 September 2016 Keywords: Eye irritation Animal alternative Reconstructed human corneal epithelium, RhCE model BCOP Contact lens ISO10993-10 Medical device abstract In an effort to explore the use of alternative methods to animal testing for the evaluation of the ocular irritancy of medical devices, we evaluated representative contact lenses with the bovine corneal opacity and permeability test (BCOP) and an in vitro eye irritation test using the three-dimensionally-reconstructed human corneal epithelium (RhCE) models, EpiOcular? and MCTT HCE?. In addition, we compared the obtained results with the ISO standard in vivo rabbit eye irritation test (ISO10993-10). Along with the positive controls (benzalkonium chloride, BAK, 0.02, 0.2, and 1%), the extracts of 4 representative contact lenses (soft, disposable, hard, and colored lenses) and 2 reference lenses (dye-eluting and BAK-coated lenses) were tested. All the lenses, except for the BAK-coated lens, were determined non-irritants in all test methods,