Safety and efficacy of topical levocabastine compared with oral terfenadine.

This double-blind, parallel-group study compared topical levocabastine (eye drops and nasal spray) and oral terfenadine in 27 patients with seasonal allergic rhinoconjunctivitis over a period of 8 weeks. The main aim of this trial was to assess the ocular tolerability of levocabastine eye drops. Comparison of therapeutic efficacy was a secondary study objective. Use of oral and ocular medication was mandatory, however the nasal spray was only to be used when required. The use of nasal spray was 46% in the levocabastine group and 56% in the terfenadine group. Ophthalmologic examinations indicated that levocabastine eye drops were well tolerated. The incidence of adverse reactions was 31% in the levocabastine group and 43% in the terfenadine group. At the end of the trial, a total of 88% of levocabastine-treated patients rated the effect of therapy on ocular symptoms to be excellent or good compared with 75% of those who received terfenadine, while 75% of patients in each group were satisfied with the effect of therapy on nasal symptoms. The investigator's evaluation of symptom severity revealed consistently better results with levocabastine. Levocabastine was significantly more effective than terfenadine in relieving ocular itching (p = .02). The patients' visual analogue scale ratings also showed significantly better results for levocabastine, particularly with respect to nasal symptoms. Levocabastine was significantly better than terfenadine for a number of symptoms on days when the pollen count was high. In conclusion, topical levocabastine appears to be a well-tolerated and effective alternative to oral terfenadine for the treatment of seasonal allergic rhinoconjunctivitis.

RCT Entities:   Population Interventions Outcomes