MedTrace Logo

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

NCT04810390 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-03-16

No results posted yet for this study

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

DRUG

Bilastine

Ophthalmic solution 0.6%

DRUG

Placebo

Ophthalmic solution

Sponsors & Collaborators

  • Dynamic Science S.L.

    collaborator INDUSTRY

  • Faes Farma, S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-26
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04810390 on ClinicalTrials.gov