Bilastine 0.6% Preservative-free Eye Drops: A Once-daily Treatment for Allergic Conjunctivitis

Abstract

Background: Bilastine is a second-generation antihistamine approved for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. The present trial evaluated the efficacy and safety of a new bilastine 0.6% preservative-free eye drop formulation for the symptomatic treatment of allergic conjunctivitis. Methods: This phase 3, multicenter, double-masked, randomized study compared the efficacy, safety, and tolerability profile of bilastine 0.6% ophthalmic solution with that of ketotifen 0.025% and vehicle. The primary efficacy endpoint was reduction in ocular itching. The Ora-CAC® Allergen Challenge Model was used to assess ocular and nasal symptoms at 15 minutes (onset of action) and 16 hours after treatment. Results: Patients (N=228) were 59.6% male, and the mean (SD) age was 44.1 (13.4) years. Bilastine demonstrated efficacy in reducing ocular itching compared to vehicle at both onset of action and 16 hours after treatment (P