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Exploration and comparison of in vitro eye irritation tests with the ISO standard in vivo rabbit test for the evaluation of the ocular irritancy of contact lenses
- Source :
- Toxicology in vitro : an international journal published in association with BIBRA. 37
- Publication Year :
- 2016
-
Abstract
- In an effort to explore the use of alternative methods to animal testing for the evaluation of the ocular irritancy of medical devices, we evaluated representative contact lenses with the bovine corneal opacity and permeability test (BCOP) and an in vitro eye irritation test using the three-dimensionally-reconstructed human corneal epithelium (RhCE) models, EpiOcular™ and MCTT HCE™. In addition, we compared the obtained results with the ISO standard in vivo rabbit eye irritation test (ISO10993-10). Along with the positive controls (benzalkonium chloride, BAK, 0.02, 0.2, and 1%), the extracts of 4 representative contact lenses (soft, disposable, hard, and colored lenses) and 2 reference lenses (dye-eluting and BAK-coated lenses) were tested. All the lenses, except for the BAK-coated lens, were determined non-irritants in all test methods, while the positive controls yielded relevant results. More importantly, BCOP, EpiOcular™, and MCTT HCE™ yielded a consistent decision for all the tested samples, with the exception of 0.2% BAK in BCOP, for which no prediction could be made. Overall, all the in vitro tests correlated well with the in vivo rabbit eye irritation test, and furthermore, the combination of in vitro tests as a tiered testing strategy was able to produce results similar to those seen in vivo. These observations suggest that such methods can be used as alternative assays to replace the conventional in vivo test method in the evaluation of the ocular irritancy of ophthalmic medical devices, although further study is necessary.
- Subjects :
- 0301 basic medicine
Male
medicine.medical_specialty
genetic structures
Contact Lenses
In Vitro Techniques
Toxicology
Animal Testing Alternatives
Eye
Epithelium
Permeability
law.invention
03 medical and health sciences
Benzalkonium chloride
0302 clinical medicine
Corneal Opacity
law
In vivo
Ophthalmology
medicine
Animals
Humans
Corneal epithelium
business.industry
General Medicine
Test method
eye diseases
In vitro
Surgery
Lens (optics)
Contact lens
030104 developmental biology
medicine.anatomical_structure
Rabbit test
030221 ophthalmology & optometry
Cattle
sense organs
Rabbits
business
medicine.drug
Subjects
Details
- ISSN :
- 18793177
- Volume :
- 37
- Database :
- OpenAIRE
- Journal :
- Toxicology in vitro : an international journal published in association with BIBRA
- Accession number :
- edsair.doi.dedup.....d642042b604375d4e24f4bcfdeba503c