A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
- Conditions
- Allergic Conjunctivitis
- Interventions
- Registration Number
- NCT03479307
- Lead Sponsor
- Faes Farma, S.A.
- 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 conjunctivitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 228
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketotifen Ophthalmic Solution 0.025% (Zaditen) Ketotifen Ophthalmic Solution 0.025% (Zaditen) Ketotifen Ophthalmic Solution 0.025% (Zaditen) 1 drop in each eye at 2 separate times during an 8 day period. Vehicle of Bilastine Ophthalmic Solution Vehicle of Bilastine Ophthalmic Solution Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 2 separate times during an 8 day period. Bilastine Ophthalmic Solution 0.6% Bilastine Ophthalmic Solution 0.6% Bilastine Ophthalmic Solution 0.6% 1 drop in each eye at 2 separate times during an 8 day period.
- Primary Outcome Measures
Name Time Method Ocular Itching The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment). The primary efficacy measure was ocular itching evaluated by the subject at 3 (± 1), 5 (±1), and 7 (± 1) minutes post-CAC (Conjunctival Allergen Challenge) at Visits 4b and 5, using a 0 to 4 Ora Calibra scale (0 = None , 4= An incapacitating itch with an irresistible urge to rub).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
East West Eye Institute
🇺🇸Torrance, California, United States
Philadelphia Eye Associates
🇺🇸Philadelphia, Pennsylvania, United States
Apex Eye
🇺🇸Mason, Ohio, United States
Cornea Consultants of AZ
🇺🇸Phoenix, Arizona, United States
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States
Total Eye Care, P.A.
🇺🇸Memphis, Tennessee, United States