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



Status:Completed
Conditions:Allergy, Ocular
Therapuetic Areas:Ophthalmology, Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:10/28/2018
Start Date:February 26, 2018
End Date:August 13, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

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.


Inclusion Criteria:

- be at least 18 years old

- be willing and able to avoid all disallowed medications and contact lenses

- must have a pregnancy test if of childbearing potential

- must be able to read an eye chart from 10 feet away

Exclusion Criteria:

- must not have any allergies to the study medications

- must not have any ocular or non ocular condition that investigator feels will
interfere with study parameters

- must not have used immunotherapy in the last 2 years

- must not have used an investigational drug or device in the past 30 days or
concurrently enrolled in another investigational trial
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