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

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

We found this trial at

sites

Philadelphia Eye Associates

1703 S. Broad Street
Philadelphia, Pennsylvania 19148

215-339-8100

Phone: 978-685-8900

from

Philadelphia, PA