NCT03231969

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

A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2, Dose Ranging Evaluation of the Effectiveness of Bilastine Ophthalmic Solution (0.2%, 0.4%, and 0.6%) Compared to Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (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 (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Bilastine 0.2%	1 drop in each eye at 3 separate times during a 25 day period.
DRUG	Bilastine 0.4%	1 drop in each eye at 3 separate times during a 25 day period.
DRUG	Bilastine 0.6%	1 drop in each eye at 3 separate times during a 25 day period.
DRUG	Bilastine 0%	1 drop in each eye at 3 separate times during a 25 day period.

Timeline

• Start date: 2017-07-20
• Primary completion: 2017-10-11
• Completion: 2017-10-11
• First posted: 2017-07-27
• Last updated: 2023-03-16
• Results posted: 2021-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study