Application of a 3D Human Cornea‐Like Epithelium for Eye Irritation Assessment of Contact Lens Solutions

Currently, medical device eye irritation testing relies on the Draize eye test in rabbits, which presents significant challenges regarding animal welfare and variations across laboratories. This research explores the application of the commercially available three-dimensional reconstructed human corneal epithelial tissue (Skinovo-Ocular) in eye irritation evaluation. The model is developed by culturing immortalized human corneal epithelial cells at a liquid-air 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-epithelial 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 vivo 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.