NCT04810390

Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in Children

Multi-centre, Randomised, Double Blind, Placebo-controlled, Parallel, Phase III Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-centre, randomised, double blind, placebo-controlled, parallel-group, phase III study to assess the safety, tolerability and efficacy of Bilastine ophthalmic solution 0.6% in children with a documented history of seasonal allergic conjunctivitis (SAC) or perennial allergic conjunctivitis (PAC).

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Bilastine	Ophthalmic solution 0.6%
DRUG	Placebo	Ophthalmic solution

Timeline

• Start date: 2021-03-26
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2021-03-23
• Last updated: 2023-03-16

Locations

18 sites across 1 country: Spain