Preliminary Study on an Alternative Test Method with MCTT HCE^TM for Ocular Irritation Test of Ophthalmic Medical Devices.

ABSTRACT: The sustained growth of the market for ophthalmic medical devices has increased the demand for alternatives to animal testing for the evaluation of eye irritation. The International Organization for Standardization has acknowledged the need to develop novel in vitro tests to replace animal testing. Here, we evaluated the applicability of an alternative method based on a human corneal model to test the safety of ophthalmic medical devices. 2-Hydroxyethyl methacrylate (HEMA) and Polymethyl methacrylate (PMMA), which are used to fabricate contact lenses, were used as base materials. These materials were blended with eye irritant and non-irritant chemicals specified in the OECD Test Guideline (TG) 492 and Globally Harmonized System (GHS) classification. Then, three GLP-certified laboratories p

SUBMITTER: Kim YJ 

PROVIDER: S-EPMC10051360 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature