To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
121
1 drop in each eye at 3 separate times during a 25 day period.
1 drop in each eye at 3 separate times during a 25 day period.
1 drop in each eye at 3 separate times during a 25 day period.
Ora Clinical Research Center
Andover, Massachusetts, United States
Ocular Itching
The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.
Time frame: The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).
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1 drop in each eye at 3 separate times during a 25 day period.