Evaluation of Ocular Itch Relief With Alcaftadine 0.25% Versus Olopatadine 0.2% in Allergic Conjunctivitis

Friday, April 25, 2014
KIOSKS (Boston Convention and Exhibition Center)
Eugene Bramlett McLaurin, MD, Total Eye Care, P.A.,, Memphis, TN, TN, USA
Nicholas P. Marsico, MD, East West Eye, Los Angeles, CA, USA
Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary, Boston, MA, USA
Linda Villanueva, COT, Allergan, Inc., Irvine, CA, USA
Julia Williams, Allergan Inc., Irvine, CA, USA
David A. Hollander, MD, MBA, UCLA, Irvine, CA, USA

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.