title: Evaluation of Eye Irritation Potential of Solid Substance with New 3D Reconstructed Human Cornea Model, MCTT HCE(TM).
abstract: The eye irritation potential of drug candidates or pharmaceutical ingredients should be evaluated if there is a possibility of ocular exposure. Traditionally, the ocular irritation has been evaluated by the rabbit Draize test. However, rabbit eyes are more sensitive to irritants than human eyes, therefore substantial level of false positives are unavoidable. To resolve this species difference, several three-dimensional human corneal epithelial (HCE) models have been developed as alternative eye irritation test methods. Recently, we introduced a new HCE model, MCTT HCE(TM) which is reconstructed with non-transformed human corneal cells from limbal tissues. Here, we examined if MCTT HCE(TM) can be employed to evaluate eye irritation potential of solid substances. Through optimization of washing method and exposure time, treatment time was established as 10 min and washing procedure was set up as 4 times of washing with 10 mL of PBS and shaking in 30 mL of PBS in a beaker. With the established eye irritation test protocol, 11 solid substances (5 non-irritants, 6 irritants) were evaluated which demonstrated an excellent predictive capacity (100% accuracy, 100% specificity and 100% sensitivity). We also compared the performance of our test method with rabbit Draize test results and in vitro cytotoxicity test with 2D human corneal epithelial cell lines.
authors.affiliation: Amorepacific Corporation R&D Center, Yongin 446-729.
authors.forename: Won-Hee
authors.initials: WH
authors.lastname: Jang
authors.affiliation: Amorepacific Corporation R&D Center, Yongin 446-729.
authors.forename: Kyoung-Mi
authors.initials: KM
authors.lastname: Jung
authors.affiliation: College of Pharmacy, Ewha Womans University, Seoul 120-808.
authors.forename: Hye-Ri
authors.initials: HR
authors.lastname: Yang
authors.affiliation: College of Pharmacy, Ewha Womans University, Seoul 120-808.
authors.forename: Miri
authors.initials: M
authors.lastname: Lee
authors.affiliation: Modern Cell & Tissue Technologies Inc., Seoul 139-743, Republic of Korea.
authors.forename: Haeng-Sun
authors.initials: HS
authors.lastname: Jung
authors.affiliation: Modern Cell & Tissue Technologies Inc., Seoul 139-743, Republic of Korea.
authors.forename: Su-Hyon
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Amorepacific Corporation R&D Center, Yongin 446-729.
authors.forename: Miyoung
authors.initials: M
authors.lastname: Park
authors.affiliation: College of Pharmacy, Ewha Womans University, Seoul 120-808.
authors.forename: Kyung-Min
authors.initials: KM
authors.lastname: Lim
keywords: Eye irritation; MCTT HCETM model; Protocol refinement; Reconstructed cornea model