Clinical evaluation of twice-daily emedastine 0.05% eye drops (Emadine eyedrops) versus levocabastine 0.05% eye drops in patients with allergic conjunctivitis

PURPOSE: The efficacy and safety of emedastine 0.05% eye drops (Emadine; Al con Laboratories, Inc, Fort Worth, Texas), a new H-1 antagonist, were studi ed in comparison to levocabastine 0.05% eye drops (Livostin; Janssen-Cilag N V, Berchem, Belgium) during a twice-daily treatment schedule for 6 weeks in adult and pediatric patients with seasonal allergic conjunctivitis. METHODS: In a prospective, multicenter, randomized, double-masked, parallel group study, 222 patients with allergic conjunctivitis were randomized (22 1 received treatment) to either emedastine or levocabastine, instilled twic e daily for 6 weeks. Patient diaries were completed four times daily (befor e the morning and evening instillations, at noon, and in the afternoon), an d clinical examinations were conducted at regular intervals. Primary effica cy variables of ocular redness and itching and secondary efficacy variables of chemosis, eyelid swelling, patient diary data, and physician's global a ssessment were analyzed. RESULTS: Both emedastine and levocabastine produced a statistically signifi cant (P = .0001) reduction in itching and redness within 5 minutes of the f irst instillation. All signs and symptoms improved progressively over the 6 -week treatment period. After 7 days of use, and throughout the remainder o f the study, emedastine was statistically superior to levocabastine (P < .0 06) in preventing and alleviating the signs and symptoms (itching, redness, chemosis, and eyelid swelling) of allergic conjunctivitis. CONCLUSIONS: Emedastine 0.05% eye drops administered twice daily are more e fficacious than levocabastine 0.05% eye drops in the prevention and treatme nt of the signs and symptoms of allergic conjunctivitis in adults and child ren of 4 years and above. Both emedastine 0.05% eye drops and levocabastine 0.05% eye drops were well tolerated. (Am J Ophthalmol 2001;131:691-698. (C ) 2001 by Elsevier Science Inc. All rights reserved.).