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.

Allergic Rhinitis and its Impact on Asthma (ARIA) 2008*

“…However, although there is a beneficial effect upon symptoms in the organ to which they are administered, they usually have little effect elsewhere. These drugs are useful in children with symptoms limited to the nose or the eyes (1408,2233,2234).…”

Allergic and Immunologic Eye Disease

“…73 Apart from the ability to inhibit histamine release from mast cells and to prevent the activation of inflammatory cells, it is likely that the antiallergic potency of azelastine is partially the result of down-regulation of ICAM-1 expression during the early-and late-phase components of ocular allergic response, probably leading to a reduction of inflammatory cell adhesion to epithelial cells and confirming the prophylactic properties of azelastine. 73 Apart from the ability to inhibit histamine release from mast cells and to prevent the activation of inflammatory cells, it is likely that the antiallergic potency of azelastine is partially the result of down-regulation of ICAM-1 expression during the early-and late-phase components of ocular allergic response, probably leading to a reduction of inflammatory cell adhesion to epithelial cells and confirming the prophylactic properties of azelastine.…”

Ocular allergy in pediatric practice

“…Azelastine 0.05% is a second-generation H 1 receptor antagonist that inhibits histamine release from mast cells and prevents activation of inflammatory cells in children with allergic conjunctivitis [37]. Azelastine is also known to downregulate ICAM-1 expression, reducing inflammatory cell adhesion to epithelial cells.…”