A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.

Phase 3 Completed 228 enrolled Faes Farma, S.A. ORA, Inc. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of allergic conjunctivitis.

Timeline

Start: 2018-04-07
Primary completion: 2018-08-09
Completion: 2018-08-10

Outcome

Met primary endpoint

registry Bilastine Ophthalmic Solution 0.6% vs Vehicle of Bilastine Ophthalmic Solution; p < 0.0001; Mean Difference (Final Values) -0.710 NCT03479307 ↗

paper Bilastine demonstrated efficacy in reducing ocular itching compared to vehicle at both onset of action and 16 hours after treatment (P<.001). PMID 36811846 ↗

Publications

Gomes PJ, Ciolino JB, Arranz P, Hernandez G, Fernandez N. Bilastine 0.6% Preservative-free Eye Drops: A Once-daily Treatment for Allergic Conjunctivitis. J Investig Allergol Clin Immunol. 2024 Jun 17;34(3):167-176. doi: 10.18176/jiaci.0894. Epub 2023 Feb 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bilastine	Small molecule	0.6 %	Topical
Comparator	Ketotifen	Small molecule	0.025 %	Topical