Evaluation of Ocular Itch Relief With Alcaftadine 0.25% Versus Olopatadine 0.2% in Allergic Conjunctivitis
Narrative Responses:
Purpose
To evaluate the safety and efficacy of the once daily anti-allergic, alcaftadine 0.25%, olopatadine 0.2%, and placebo in preventing the ocular itching of allergic conjunctivitis.
Methods
Pooled analysis of two double-masked, randomized, multicenter, active and placebo controlled studies using the Conjunctival Allergen Challenge (CAC) model of allergic conjunctivitis. Subjects were randomized into one of 3 treatment arms: alcaftadine 0.25%, olopatadine 0.2%, or placebo (artificial tear). The primary efficacy measure was subject-evaluated mean ocular itching 16 hours post dose. Itch was measured on a 0-4 scale at 3, 5, and 7 minutes post allergen challenge.
Results
A total of 284 subjects were enrolled in the 2 studies. At 16 hours post dose, subjects treated with alcaftadine demonstrated a significantly lower overall mean itch score at the 3, 5 and 7 minute timepoints than those treated with olopatadine (alcaftadine: 0.68 versus olopatadine: 0.92, p=0.0390). 76.1% of alcaftadine subjects reported minimal itch (itch score <1) vs 58.1% of olopatadine (p= 0.0121). Both alcaftadine and olopatadine treated subjects achieved significantly lower mean ocular itching scores versus placebo (mean itch=2.10, p<0.0001), and both treatments were safe and well tolerated.
Conclusion
Once daily alcaftadine 0.25% ophthalmic solution demonstrated greater efficacy in preventing overall ocular itching compared to olopatadine 0.2% in a CAC model at 16 hours post dose. Alcaftadine and olopatadine both provided highly effective relief versus placebo and were safe and well tolerated.