title: Azelastine eye drops in the treatment of seasonal allergic conjunctivitis or rhinoconjunctivitis in young children.
abstract: 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 eye drops (n = 32 patients) during a 14-day treatment period involving 113 children (aged 4 to 12 years) suffering from seasonal allergic conjunctivitis/rhinoconjunctivitis. The primary variable was the response rate defined as the number of patients showing an improvement after three days of treatment of at least three score points, from a minimum baseline score of six, in the main ocular symptoms of itching, conjunctival redness and lacrimation (each assessed on a four-point scale). Patients discontinuing due to inefficacy were regarded as non-responders. The mean response rate in the azelastine eye drops group (74%) was significantly higher (p < 0.01) than that in the placebo group (39%) and comparable with that in the levocabastine group. The response rates assessed by the patients in their diaries were very similar. Significant differences (p < 0.01) for azelastine compared with placebo were observed on days 3 and 14 in the mean sum scores for the three main symptoms 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 were mainly local irritant effects. Overall tolerability was assessed as very good or good in 80%, 84% and 91% of placebo-, azelastine- and levocabastine-treated patients, respectively. Azelastine eye drops are effective and well-tolerated in children with seasonal allergic conjunctivitis.
authors.affiliation: CHU d'Angers, France.
authors.forename: A
authors.initials: A
authors.lastname: Sabbah
authors.forename: M
authors.initials: M
authors.lastname: Marzetto
mesh_terms: D002648:Child; D002675:Child, Preschool; D003233:Conjunctivitis, Allergic / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009883:Ophthalmic Solutions; D010793:Phthalazines / Q000627:therapeutic use*; D010880:Piperidines / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000150:complications / Q000188:drug therapy*; D012720:Severity of Illness Index
chemical_list: D006634:Histamine H1 Antagonists; D009883:Ophthalmic Solutions; D010793:Phthalazines; D010880:Piperidines; C047340:levocabastine; C020976:azelastine