This multicenter, randomized, double-blind placebo-controlled study was conducted to assess the efficacy and safety of two doses of olopatadine nasal spray as a treatment for SAR (Mountain Cedar season).

Patients assessed morning and evening reflective (refl) and instantaneous (inst) nasal and ocular symptoms including rhinorrhea, sneezing, itchy nose and congestion on a 0-3 scale. After a 3-21 day single blind placebo spray run-in period, 677 patients ages 12-81 with a minimum total nasal symptom score (TNSS) of 36 out of a possible 72 were randomized to olopatadine 0.4% (n=229), 0.6% (n=223), or placebo (n=225) 2 sprays/nostril BID for 2 weeks.

Olopatadine HCl nasal spray 0.4% & 0.6% were significantly superior to placebo for percent change from baseline in overall refl (p=0.0002 & <0.0001, respectively) and inst (p=0.0015 & <0.0001, respectively) TNSS over a 2 week period. Olopatadine spray 0.6% was superior to placebo for individual nasal symptoms of runny nose, itchy nose, congestion and sneezing. The 0.4% spray was (generally) less effective than 0.6% but superior to placebo in most cases for the individual nasal symptoms. Treatment with Olopatadine HCl nasal spray 0.4% or 0.6%, BID, was safe and well tolerated. No serious adverse events related to any treatment were reported in this study.

Olopatadine HCl nasal spray 0.4% & 0.6% are well tolerated and provide statistically significant improvements in symptoms in patients with seasonal allergic rhinitis.