AZELASTINE EYE DROPS IN THE TREATMENT OF SEASONAL ALLERGIC CONJUNCTIVITIS OR RHINOCONJUNCTIVITIS IN YOUNG-CHILDREN

In a randomised, multicentre study, the effect of azelastine eye drops (n = 51 patients) was compared in a double-blind manner with placebo eye drops (n = 30 patients) and in an open manner with levocabastine e ye drops (n = 32 patients) during a 14-day treatment period involving 113 children (aged 4 to 12 years) suffering from seasonal allergic con junctivitis/rhinoconjunctivitis. The primary variable was the response rate defined as the number of patients showing an improvement after t hree days of treatment of at least three sore points, from a minimum b aseline score of six, in the main ocular symptoms of itching, conjunct ival redness and lacrimation (each assessed on a four-point scale). Pa tients discontinuing due to inefficacy were regarded as non-responders . The mean response rate in the azelastine eye drops group (74%) was s ignificantly higher (p < 0.01) than that in the placebo group (39%) an d comparable with that in the levocabastine group. The response rates assessed by the patients in their diaries were very similar. Significa nt differences (p < 0.01) for azelastine compared with placebo were ob served on days 3 and 14 in the mean sum scores for the three main symp toms and for a total of eight eye symptoms. The overall assessment of efficacy confirmed the superiority of both active treatments compared with placebo. Adverse drug reactions were reported in 23% of placebo-, 35% of azelastine- and 38% of levocabastine-treated patients. These w ere mainly local irritant effects. Overall tolerability was assessed a s very good or good in 80%, 84% and 91% of placebo-, azelastine- and l evocabastine-treated patients, respectively. Azelastine eye drops are effective and well-tolerated in children with seasonal allergic conjun ctivitis.