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This research explores the application of the commercially available three\u2010dimensional reconstructed human corneal epithelial tissue (Skinovo\u2010Ocular) in eye irritation evaluation. The model is developed by culturing immortalized human corneal epithelial cells at a liquid\u2010air interface, resembling the morphology and induction of biological indicators found in human corneal tissue. We evaluated the eye irritation effect of 30 minimum reference chemicals according to OECD Performance Standards. The results revealed a sensitivity of 100%, specificity of 66.7%, and accuracy of 83.3%, indicating predictive performance comparable to other reference methods. Furthermore, we conducted analyses including trans\u2010epithelial electrical resistance, cytokine secretion, and histology, thereby enhancing our understanding of the mechanisms underlying eye irritation assessment in this model. Additionally, we tested various contact lens solutions and compared the results with rabbit in\u00a0vivo experiments, demonstrating the model's potential for analyzing the eye irritation of mixtures. This model shows promise as an alternative for eye irritation analysis of medical devices, further reducing the reliance on experimental animals.<\/jats:p>","DOI":"10.1002\/jat.4820","type":"journal-article","created":{"date-parts":[[2025,5,27]],"date-time":"2025-05-27T19:49:19Z","timestamp":1748375359000},"page":"1984-1994","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Application of a 3D Human Cornea\u2010Like Epithelium for Eye Irritation Assessment of Contact Lens Solutions"],"prefix":"10.1002","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2192-2963","authenticated-orcid":false,"given":"Xian","family":"He","sequence":"first","affiliation":[{"name":"Zhejiang Institute of Medical Device Supervision and Testing  Hangzhou China"},{"name":"NMPA Key Laboratory for Biomedical Optics  Hangzhou China"},{"name":"Key Laboratory of Safety Evaluation of Medical Devices of Zhejiang Province  Hangzhou 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