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Y Gao, NJ Feldhan, KP Lockwood, MJ Muscatiello, BE Kanengiser; New Approach to the Assessment of Ocular Irritancy of Eye Area Products . Invest. Ophthalmol. Vis. Sci. 2002;43(13):351.
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Purpose: The purpose of this study was to introduce a new method of assessing the ocular irritancy of a specific class of cosmetic and consumer products that potentially migrate from the periocular skin onto the surface of ocular tissues. The sub-acute methodology was developed to evaluate the safety of this class of test materials, which include eye creams, mascaras, eye shadows, concealers, sunscreens and wrinkle creams, in human subjects under exaggerated use conditions by evaluating both subjective reports of irritation and objective evidence of irritation on each of the ocular tissues. Methods: Human subjects were required to apply a measured quantity of the test material, in an amount exceeding that which would normally be used, evenly to the entire periorbital area including the eyelids. Multiple applications were performed daily during a 5 day period. All ocular tissues were examined and scored using Kanengiser’s unique and sensitive scoring scale, which assesses both the area and density of fluorescein staining of component areas of the ocular tissues using a 13-point grading scale, immediately after use of the test material and at post-application intervals. Objective findings and subjective responses were recorded. Additional subjective assessments were captured during at-home application by the subjects. The data collected from 300 subjects were reviewed and analyzed to demonstrate clinical significance, with respect to the patterns and levels of ocular irritancy that were observed and/or reported. Results: From this study, we have demonstrated that the human sub-acute methodology is an effective and safe in vivo manner of investigating cosmetic and consumer products that potentially migrate onto the ocular tissues. This exaggerated use methodology provided informative results in a very short time, assessing both the immediate reaction to a single application as well as the effect of cumulative exposure. Ocular examinations, utilizing Kanengiser’s scoring system, demonstrated varying levels and patterns of ocular tissue sensitivities during the course of test material use. Conclusion: The sub-acute methodology represents a reliable, predictable and reproducible ocular irritant test to assess the in-use safety of a particular class of cosmetic and consumer products. This methodology, with its exaggerated application procedures and comprehensive and sensitive examination and scoring system, is capable of predicting, in a very short time, the potential of eye area products to elicit irritation.
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