Eye Irritation Test (EIT) for Hazard Identification of Eye Irritating Chemicals using Reconstructed Human Cornea-like Epithelial (RhCE) Tissue Model

Kaluzhny, Yulia; Kanďárová, Helena; d’Argembeau-Thornton, Laurence; Kearney, Paul; Klausner, Mitchell

doi:10.3791/52979

Cited by 7 publications

(4 citation statements)

References 13 publications

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“…32 This Test Guide, named OECD TG 492, describes an in vitro procedure that allows the identification of toxic and harmful chemicals (substances and mixtures) not requiring classification for eye irritation or serious eye damage by using human reconstructed corneal tissues. 33 These tissues closely reproduce the main feature of in vivo human cornea since they show physiological, morphological, histological and biochemical properties of the human corneal epithelium. The RhCE tissues are produced from human immortalized corneal epithelial cells, primary human epidermal keratinocytes or primary culture human corneal epithelial cells, which are kept in controlled condition of temperature for several days to generate a highly differentiated, multi-stratified squamous epithelium morphologically similar to the human cornea.…”

Section: Application Of Human Cornea-like Epithelium: Irritation Testmentioning

confidence: 72%

Development of In Vitro Corneal Models: Opportunity for Pharmacological Testing

Citi¹,

Piragine²,

Brogi³

et al. 2020

Preprint

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Human eye is a specialized organ with complex anatomy and physiology, because it is characterized by different cell types with specific physiological functions. Given the complexity of the eye, ocular tissues are finely organized and orchestrated. In the last few years many in vitro models have been developed, in order to meet the 3Rs principle (Replacement, Reduction and Refinement) for eye toxicity testing. This procedure is highly necessary to ensure that the risks associated with ophthalmic products meet appropriate safety criteria. In vitro preclinical testing is now a well-established practice of significant importance for evaluating the efficacy and safety of cosmetic, pharmaceutical, and nutraceutical products. Along with in vitro testing, also computational procedures, herein described, for evaluating the pharmacological profile of potential ocular drug candidates including their toxicity, are in rapid expansion. In this review the ocular cell types and functionality are described providing an overview about the scientific challenge for the development of three-dimensional in vitro models.

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Section: Application Of Human Cornea-like Epithelium: Irritation Testmentioning

confidence: 72%

Development of In Vitro Corneal Models: Opportunity for Pharmacological Testing

Citi¹,

Piragine²,

Brogi³

et al. 2020

Preprint

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“…The standard protocol of EpiOcular™ Eye Irritation Test (OCL-200-EIT) as described by Kaluzhny et al was employed in this study. 14 The RhCE tissue cultures were dispensed into the 6-well plates containing 1 mL of assay medium OLC-200-ASY in each well (MatTek Corporation, USA). They were then pre-incubated for an hour under the standard culture conditions (SCC) of 37°C, 5% CO 2 , and 95% humidity.…”

Section: Aterials and M Ethodsmentioning

confidence: 99%

In Vitro Toxicity Evaluation of New Generic Latanost® and Latacom® as an Ophthalmic Formulation

Ng¹,

Tan²,

Alwi³

et al. 2022

Journal of Current Glaucoma Practice

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A bstract Aim and objective To evaluate the safety of two new generic ophthalmic formulations, Latanost ® (latanoprost) and Latacom ® (latanoprost and timolol) by utilizing the three-dimensional reconstructed human cornea-like epithelium (RhCE) tissue constructs as an in vitro model in the assessment of ocular irritation. Materials and methods In vitro irritation test was conducted on Latanost ® (LTN) and Latacom ® (LTC) and their corresponding innovators, Xalatan ® (XLT) and Xalacom ® (XLC), respectively, by using RhCE. According to the OECD guidelines No. 492 on the testing of chemicals, the ophthalmic formulations were assessed via topical exposure of the formulations on in vitro RhCE tissue. Cell viability was measured by MTT assay. Results The mean cell viability percentage of LTN and XLT was 70.5 and 75.7%, respectively, whereas, for LTC and XLC, the percentage viability was 95.3 and 85.7%, respectively. The two new generic formulations (LTN and LTC) did not reduce the cell viability of the RhCE tissue to ≤60%. Thus, both can be considered as nonirritant. Conclusion Both newly developed generics are nonocular irritants. Clinical significance This study informs the safety assessment of new generic antiglaucoma ophthalmic solutions applicable for long-term glaucoma treatment. The formulations aim to keep eye irritation to a minimum level. How to cite this article Ng JSC, Tan YX, Alwi NAA, et al. In Vitro Toxicity Evaluation of New Generic Latanost ® and Latacom ® as an Ophthalmic Formulation. J Curr Glaucoma Pract 2021;15(3):139–143.

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“…Four reconstructed human corneal-like epithelium models are included as validated reference methods in the 18 June 2019 version of the Organisation for Economic Cooperation and Development Test Guidelines (OECD TG) 492 for assessing eye irritation or serious eye damage: EpiOcular™ (MatTek, Ashland, MA USA), SkinEthic Human Corneal Epithelium (HCE)™ (SkinEthic, Lyon, France), LabCyte CORNEA-MODEL24 (Japan Tissue Engineering Co. Ltd., Miyakitadori, Aichi, Japan), and MCTT HCE™ [ 53 ]. EpiOcular™ was developed and commercialized by MatTek Corporation [ 54 , 55 , 56 , 57 , 58 , 59 ] and provides an alternative to animal testing to determine Draize scores. However, it is prepared with nonocular cells.…”

Section: Three-dimensional In Vitro Models Of Anterior Eye Tissuesmentioning

confidence: 99%

Three-Dimensional Human Cell Culture Models to Study the Pathophysiology of the Anterior Eye

García-Posadas

Diebold

2020

Pharmaceutics

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In recent decades, the establishment of complex three-dimensional (3D) models of tissues has allowed researchers to perform high-quality studies and to not only advance knowledge of the physiology of these tissues but also mimic pathological conditions to test novel therapeutic strategies. The main advantage of 3D models is that they recapitulate the spatial architecture of tissues and thereby provide more physiologically relevant information. The eye is an extremely complex organ that comprises a large variety of highly heterogeneous tissues that are divided into two asymmetrical portions: the anterior and posterior segments. The anterior segment consists of the cornea, conjunctiva, iris, ciliary body, sclera, aqueous humor, and the lens. Different diseases in these tissues can have devastating effects. To study these pathologies and develop new treatments, the use of cell culture models is instrumental, and the better the model, the more relevant the results. Thus, the development of sophisticated 3D models of ocular tissues is a significant challenge with enormous potential. In this review, we present a comprehensive overview of the latest advances in the development of 3D in vitro models of the anterior segment of the eye, with a special focus on those that use human primary cells.

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Eye Irritation Test (EIT) for Hazard Identification of Eye Irritating Chemicals using Reconstructed Human Cornea-like Epithelial (RhCE) Tissue Model

Cited by 7 publications

References 13 publications

Development of In Vitro Corneal Models: Opportunity for Pharmacological Testing

Development of In Vitro Corneal Models: Opportunity for Pharmacological Testing

In Vitro Toxicity Evaluation of New Generic Latanost® and Latacom® as an Ophthalmic Formulation

Three-Dimensional Human Cell Culture Models to Study the Pathophysiology of the Anterior Eye

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