Bilastine 0.6% Preservative-Free Eye Drops as an Effective Once-Daily Treatment for the Signs and Symptoms of Allergic Conjunctivitis: A Pooled Analysis of 2 Randomized Clinical Trials

Abstract

Background: Allergic conjunctivitis is the most common type of ocular allergy. Objective: The objective of this study was to evaluate the efficacy of a new once-daily, preservative-free, bilastine 0.6% eye drop formulation for the treatment of allergic conjunctivitis. Methods: Two double-masked, vehicle-controlled, clinical studies (a phase 2 dose-ranging study and a phase 3 efficacy study) were conducted to assess the efficacy of bilastine ophthalmic solution for treatment of the signs and symptoms of allergic conjunctivitis. Both studies used the Ora-CAC® Conjunctival Allergen Challenge (CAC) model to enable observation of allergic responses under controlled conditions. Each study was analyzed separately and then combined to create an integrated data set. Results: Efficacy was achieved for the primary efficacy endpoint of ocular itching with 3 bilastine concentrations (0.2%, 0.4%, and 0.6%) at 15 minutes and 8 hours after instillation. Bilastine 0.6% ophthalmic solution was also efficacious at 16 hours after instillation. Bilastine 0.6% ophthalmic solution demonstrated noninferiority to ketotifen 0.025% at the onset of action. According to the integrated data set, differences between vehicle and bilastine 0.6% after instillation were significant at all time points both at onset (15 minutes) and after a prolonged duration (16 hours). Conclusion: This multitrial assessment suggests that bilastine 0.6% ophthalmic solution is efficacious for the treatment of the signs and symptoms of allergic conjunctivitis, with a rapid onset and prolonged duration of action, and has a favorable safety profile. The added convenience of once-daily dosing may contribute to adherence and improve quality of life.