Status:
COMPLETED
A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
Lead Sponsor:
Faes Farma, S.A.
Collaborating Sponsors:
ORA, Inc.
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 conjunctiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2018
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT03479307
Start Date
April 7 2018
End Date
August 10 2018
Last Update
March 16 2023
Active Locations (6)
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1
Cornea Consultants of AZ
Phoenix, Arizona, United States, 85032
2
East West Eye Institute
Torrance, California, United States, 90505
3
Andover Eye Associates
Andover, Massachusetts, United States, 01810
4
Apex Eye
Mason, Ohio, United States, 45040