DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF 2 CONCENTRATIONS OF AZELASTINE EYE DROPS IN SEASONAL ALLERGIC CONJUNCTIVITIS OR RHINOCONJUNCTIVITIS

This double-blind, randomised, placebo-controlled study was carried ou t to assess the efficacy and safety of 0.025% and 0.05% azelastine eye drops twice daily administered for 14 days to patients with seasonal allergic conjunctivitis or rhinocojunctivitis. A total of 278 patients were recruited and 226 patients were evaluable for per protocol analy sis. The target parameter was the response rate. Four eye symptoms, in cluding the main symptom (itching) were recorded by patients in diarie s and eight symptoms were assessed by physicians before and after seve n and 14 days of treatment. Severity of symptoms was measured on a fou r-point scale. The response rates for itching (improvement of at least one score point within the first three days) according to patient ass essment were 43% for placebo, 52% for 0.025% and 56% for 0.05% azelast ine (NS). However a more objective assessment of the three main eye sy mptoms by physicians showed a concentration-dependent improvement in r esponse rate compared with placebo (a decrease of greater than or equa l to 3 points from a baseline total score of greater than or equal to 6), which reached statistical significance for 0.05% azelastine on Day 7 (p < 0.002). In the evaluable patient population, the scores of the three main eye symptoms as well as of all eight recorded eye symptoms as assessed by the physician, were significantly (p < 0.05) lower in the 0.05% azelastine eye drops group in comparison with the placebo gr oup at Day 7. Inefficacy was the cause of withdrawal in five and three patients on 0.025% and 0.05% azelastine, respectively, and in six pat ients on placebo. Adverse drug effects, mainly a mild, transient irrit ation and a bitter or unpleasant taste, were reported by 14% (0.025%), 20% (0.05%) and 15% (placebo) of the patients. No serious side-effect s occurred. Azelastine eye drops are effective and well tolerated at a concentration of 0.05% for the treatment of seasonal allergic conjunc tivitis.