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.

BACKGROUND AND OBJECTIVES

Allergic conjunctivitis is the most common type of ocular allergy. 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.