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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Cornea Consultants of AZ
Phoenix, Arizona, United States
East West Eye Institute
Torrance, California, United States
Andover Eye Associates
Andover, Massachusetts, United States
Apex Eye
Mason, Ohio, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States
Total Eye Care, P.A.
Memphis, Tennessee, United States
Start Date
April 7, 2018
Primary Completion Date
August 9, 2018
Completion Date
August 10, 2018
Last Updated
March 16, 2023
228
ACTUAL participants
Bilastine Ophthalmic Solution 0.6%
DRUG
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
DRUG
Vehicle of Bilastine Ophthalmic Solution
DRUG
Lead Sponsor
Faes Farma, S.A.
Collaborators
NCT05839938
NCT05186025
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05191186