COMPARATIVE ASSESSMENT OF TWO EYE AREA COSMETIC FORMULATIONS THROUGH EVALUATION OF ALTERNATIVE EYE IRRITATION METHODS RELATIVE TO ENDPOINTS MEASURED IN A HUMAN CLINICAL SUB-ACUTE STUDY DESIGN.
Evaluating ocular irritation of eye-area cosmetics is essential to their safety assessment. Although eye-area formulations are designed to be mild, subjective/objective ocular responses can limit their acceptability. This study evaluated two similar formulations by comparing alternative assays, selected for their ability to distinguish milder effects, to human objective and subjective endpoints assessed by a sub-acute human eye irritation design. Ocular irritation alternative assays included Hen’s Egg Test-Chorioallantoic Membrane (HETCAM) assay, Cytosensor ® Microphysiometer Bioassay (CMB), and EpiOcular (EPO) tissue construct assay. HETCAM evaluates inflammatory responses in a complete tissue model. CMB uses L929 cells to evaluate cytotoxicity through metabolic rate measurements. EPO uses differentiated human epidermal keratinocytes, having stratified into a squamous epithelium similar to corneal tissue. Human ocular irritation was assessed through subjective and objective measures at post-application intervals. Ocular exams included evaluation of the area/density of fluorescein staining of all tissues utilizing Kanengiser’s 13-point scale. Each formulation was assessed simultaneously by randomized, periorbital application to paired contralateral eye areas in an exaggerated use design. Clinical results indicated formulation A elicited a slightly greater magnitude and frequency of subjective and objective findings compared to formulation B. Results of alternative assays predicted both formulations were mild but were not entirely consistent in terms of rank ordering relative to the human responses. This study demonstrates the need to consider a battery of alternative assays when screening formulations for distinguishing mild ocular effects and the potential of this clinical protocol in predicting differences in eye irritation potential of mild formulations.
Bulbar conjunctival irritation, CMB, Corneal epithelium, Cytosensor microphysiometer bioassay (CMB), Draize, EPO, EpiOcular, Eye area cosmetics, HETCAM assay, Hen’s egg test-chorioallantoic membrance assay, Kanengiser’s 13 point scale, L929 Cells, OCL-200, Objective ophthalmic scoring scale, Ocular Irritation, Palpebral and bulbar conjunctival, caruncular and corneal fluorescein ophthalmic -staining scale, Palpebral conjunctival irritation, Safety assessment
Allantoin, Aqua, Benzyl Alcohol, Chamomilla recutita (matricaria) extract, Chlorhexidine dihydrochloride, Cucumis sativus (cucumber) fruit, Dipotassium phosphate, Disodium EDTA, Disodium cocoamphodiacetate, EDTA, Extract, Fragrance, Hexylene glycol, Imidazolidinyl urea, Magnesium laureth sulfate, Magnesium laureth-8 sulfate, Magnesium oleth sulfate, Methyldibromo glutaronitrile, Methylparaben, Panthenol, Phenoxyethanol, Potassium phosphate, Rosa centifolia flower water, SLS, Sodium benzoate, Sodium chloride, Sodium laureth sulfate, Sodium laureth-8 sulfate, Sodium oleth sulfate
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