Abstract
AbstractAn approach for evaluating drugs as contact ocular allergens is proposed that includes the evaluation of compounds in a sensitization test with dermal and ocular challenges in addition to the required ocular irritation studies. Five compounds reported as contact ocular sensitizers in humans or animals were evaluated using this model: atropine, neomycin, phenylephrine, and experimental formulas L-645,151, and L-653,328. All five gave positive results upon skin and ocular challenge. Atropine, L-645,151, and L-653,328 demonstrated adverse ocular reactions after long-term administration in the ocular irritation studies. The clinical and microscopic appearance of the ocular reactions in guinea pigs, rabbits, and dogs was also defined. Topical ocular irritation studies required in the development of ophthalmic agents do not always detect adverse ocular reactions evidenced in humans. The guinea pig maximization test (GPMT) with skin or ocular challenge identifies qualitatively potential contact ocular al...
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