A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model

Summary

To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis

Timeline

Start

2017-07-20

Primary completion

2017-10-11

Completion

2017-10-11

Outcome

Met primary endpoint

registry analysis (superiority test); Bilastine 0.2% vs Bilastine 0% (Vehicle); p = 0.0002; Mean Difference (Final Values) -0.791 (95% CI -1.203 to -0.378); ANCOVA NCT03231969 ↗

registry analysis (superiority test); Bilastine 0.4% vs Bilastine 0% (Vehicle); p <.0001; Mean Difference (Final Values) -0.851 (95% CI -1.263 to -0.439); ANCOVA NCT03231969 ↗

registry analysis (superiority test); Bilastine 0.6% vs Bilastine 0% (Vehicle); p <.0001; Mean Difference (Final Values) -1.545 (95% CI -1.954 to -1.135); ANCOVA NCT03231969 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bilastine	Small molecule	0.2 %	Other
Subject	Bilastine	Small molecule	0.4 %	Other
Subject	Bilastine	Small molecule	0.6 %	Other

Indications