NCT03479307

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

A Multi-Center, Double-Masked, Randomized, Vehicle- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Bilastine Ophthalmic Solution 0.6% Compared to Vehicle and Zaditen (Ketotifen Ophthalmic Solution 0.025%) for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Bilastine Ophthalmic Solution 0.6%	1 drop in each eye at 2 separate times during an 8 day period.
DRUG	Ketotifen Ophthalmic Solution 0.025% (Zaditen)	1 drop in each eye at 2 separate times during an 8 day period.
DRUG	Vehicle of Bilastine Ophthalmic Solution	1 drop in each eye at 2 separate times during an 8 day period.

Timeline

• Start date: 2018-04-07
• Primary completion: 2018-08-09
• Completion: 2018-08-10
• First posted: 2018-03-27
• Last updated: 2023-03-16
• Results posted: 2021-12-14

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study