Safety and efficacy comparison of emedastine 0.05% ophthalmic solution compared to levocabastine 0.05% ophthalmic suspension in pediatric subjects with allergic conjunctivitis

Purpose: To determine the efficacy and tolerance of emedastine 0.05% ophtha lmic solution compared to levocabastine 0.05% ophthalmic suspension in pedi atric subjects. Methods and Materials: In a randomized, double-masked, parallel controlled study, emedastine 0.05% ophthalmic solution BID was compared to levocabasti ne 0.05% ophthalmic suspension BID for control of the signs and symptoms of allergic conjunctivitis in pediatric subjects ages 3-16, Subjects who met all inclusion and exclusion criteria received masked study medication with instructions to instill drops twice daily, in the morning and evening. A di ary was completed by the parents four times daily for the first two and las t two weeks of the study, Treatment lasted 42 days. Drug efficacy was asses sed at the initial administration in the office at Day 0 and after 3, 7, 14 , 30 and 42 days. Results: Overall results showed both drugs have an effect and that emedasti ne was significantly superior (p<0.05) to levocabastine for the relief of c hemosis on Days 14, 30 and 42; of itching on follow-up Days 30 and 42 (p<0. 05); of redness on Days 30 and 42; for eyelid swelling on Days 14 and 30; a nd for physician's impression score on Days 7, 14, 30 and 42, Conclusion: These results confirm previous preclinical and clinical data on the potent and long acting efficacy of this promising new ophthalmic anti- allergic drug, emedastine in pediatric subjects.