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Jack V. Greiner, Avner Ingerman; The Effectiveness of Alcaftadine Ophthalmic Solution as Evaluated in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis at 15 Minutes and 16 Hours After Instillation. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6427.
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To evaluate the effectiveness of alcaftadine 0.05%, 0.1%, and 0.25% ophthalmic solutions compared to placebo for the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) clinical model. The study design included an active comparator (olopatadine hydrochloride 0.1% ophthalmic solution).
170 subjects were randomized into 1 of 5 treatment groups; 164 subjects completed all study visits. At screening Visits 1 and 2, a CAC was performed to determine then confirm the eligibility of subjects. The CAC was repeated at treatment visits_Visit 3 (day 0±3), 16 hours post-test agent instillation and Visit 4 (day 14±3), 15 minutes post-agent instillation. Ocular itching, conjunctival redness and other signs and symptoms of allergy were evaluated after allergen challenge.
At Visits 3 and 4, alcaftadine 0.25% and olopatadine 0.1% treatments exhibited significantly lower mean scores compared to placebo for conjunctival redness. Regarding ocular itching scores at Visit 4, all active treatment groups were clinically (≥1 unit difference) and statistically (p<0.001) superior to placebo at all time points. Mean differences from placebo for alcaftadine 0.25% were -1.95, -1.92, and -1.77 units at 3, 5, and 7 minute post-CAC time points, respectively. For the corresponding times, olopatadine itch scores were -1.89, -1.84, and -1.66, respectively. At Visit 3, all three alcaftadine concentrations produced lower mean ocular itching scores in subjects than either placebo and olopatadine treatment. All doses of alcaftadine were well tolerated. Reported adverse events were mild in severity.
Alcaftadine 0.25% ophthalmic solution demonstrated a rapid onset of action (15 min) and prolonged duration of action (16 hrs). The significant improvement over placebo treatment (p<0.001) in the symptom of itching due to allergic conjunctivitis, makes alcaftadine 0.25% an optimal choice for once-daily-dosing.
Clinical Trial: :
unregistered, IntegReview Protocol 04-003-10
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