Mar 22 2004
Alcon announced today results from a Phase III clinical trial demonstrating that olopatadine nasal spray, a nasal formulation of its market leading ophthalmic anti-allergy product, Patanol(R) ophthalmic solution, reduced seasonal allergic rhinitis (SAR) symptoms compared to placebo.
The results of this multi-center, randomized, double-blind, placebo-controlled study of 677 patients were presented at the annual meeting of the American Academy of Allergy Asthma and Immunology (AAAAI) in San Francisco.
Patients ranging in age from 12 to 81 were dosed with either olopatadine nasal spray (0.6% or 0.4%) or a placebo spray twice a day for two weeks. Every day during the study, patients recorded a morning and evening assessment of the severity of nasal allergy symptoms on a scale of zero to three, including both a reflective and instantaneous rating.
The reflective rating assessed how the patient felt over the course of the day, while the instantaneous rating assessed how the patient felt immediately after using the spray. The primary objective of the study was to determine the change from baseline in the total nasal symptom score, defined as the average of the morning and evening reflective severity scores for all patients across all days.
The nasal composite score measured a combination of sneezing and stuffy, runny and itchy nose symptoms. The study also measured each individual symptom's reflective score.