Post-Marketing Surveillance of Levocabastin Eye Droups in 1997: A Multicenter Surveillance Study

ABSTRACT

A multicenter post-marketing surveilance study has been conducted to evaluate the efficacy and safety of levocabastine eye drops(0.5mg/ml). Total 340 patients suffering from allergic conjunctivitis(96%) or other similar ophthalmic disorders were participated. Clinical symptoms(itching, hyperemia, tearing and chemosis) were assessed according to a four point scale before treatment and at every visit. Total symptom severity score before therapy, 6.67(N=340), was remarkably decreased to 3.28(N=252) at 1 week, and to 2.39(N=197) at 2 weeks. The physicians rated the application as `very effective` 1.5% of patients. Adverse reactions(10.3%) were limited to ocular irritation like stinging and burning sensation. These events were even lower in children(age OR =65 yrs) showing 7.0% and 9.5% respectively. Patients with gepatic, renal impairment and hypertension did not experience any special adverse effects. The overall assessment by physicians showed that the application in 80.9% of the patients was evaluated above `useful`(i.e, `very useful`; 17.1%, `useful`; 63.8%, `slighty useful`; `7.1%). therefore, it was conclued that levocabastine eye drops is a a safe and effective treatment for allergic conjnctivitis and other similar ophthalmic disorders.