Abstract

This open-label, prospective, multicentre, 4-week trial was undertaken to assess the efficacy and tolerability of twice daily levocabastine eye drops (0.5 mg/ml), with sodium cromoglycate nasal spray for the relief of concurrent nasal symptoms if required, in a total of 233 children with seasonal allergic conjunctivitis. No correlation between efficacy, tolerability and age was found. Investigator assessments revealed that the total severity of ocular symptoms decreased by 84 ± 34% in patients < 12 years and 85 ± 30% in those ≥ 12 years, with corresponding reductions in the total severity of ocular findings of 84% in both patient groups over the 4-week treatment period. Global assessments of therapeutic efficacy revealed the effect of therapy on ocular symptoms to be excellent or good in 81% of patients < 12 years and 82% of those ≥ 12 years after 2 weeks of treatment, with corresponding values at the end of the trial of 88% and 82% in the two groups, respectively. Treatment tolerability was considered to be excellent or good by 94% of patients overall. Application site reactions were the most common adverse event associated with ocular levocabastine, occurring in 13% of patients < 12 years and 9% of those ≥ 12 years. Twice daily levocabastine eye drops therefore appear to be effective and well tolerated for the treatment of seasonal allergic conjunctivitis in children.

Highlights

  • Levocabastine is a novel selective H-receptor antagonist which has been developed as eye drops and nasal spray for the topical treatment of allergic rhinoconjunctivitis

  • 8.9% of those > 12 years) and/or ocular irritation. The results of this open-label, prospective, multicentre trial clearly demonstrate that levocabastine eye drops are effective and well-tolerated for the treatment of allergic conjunctivitis in children, with no apparent correlation between efficacy, tolerability and age

  • Levocabastine was found to be well-tolerated with adverse events reported in 18.6% of children and 12.5% of adolescents

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Summary

Introduction

Levocabastine is a novel selective H-receptor antagonist which has been developed as eye drops and nasal spray for the topical treatment of allergic rhinoconjunctivitis. The efficacy and tolerability of levocabastine eye drops in the treatment of allergic conjunctivitis in adults is well documented.[5] Comparative studies have shown that levocabastine eye drops administered twice daily are at least as effective as standard daily doses of oral antihistamines(’-1 and significantly more effective than sodium cromoglycate four times daily. Levocabastine eye drops have been shown to be significantly more effective than the topical antihistamine/vasoconstrictor combination, anta-. Preliminary studies in children, involving a total of 157 patients, have shown that levocabastine eye drops administered twice daily are at least as effective and well-tolerated as sodium cromoglycate four times daily for the treatment of allergic conjunctivitis, both as single agent therapy1’,16 and as an adjunct to oral antihistamine therapy. Assessment of any correlation between efficacy, tolerability and age (< 12 years and > 12 years) was a secondary aim

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