Abstract

Objective To evaluate the efficacy of imported ketotifen fumarate 0.025%ophthalmic solution in alleviating ocular itching and conjunctivai hyperemia in patients with seasonal allergic conjunctivitis.Methods A randomized,double-masked,mnlti-centre,parallel.group clinical study was carried out.Two hundred and twenty-nine patients with seasonal allergic con3unctivitis enrolled into the trial were randomly divided intotwogroups:thetreatmentgroup(n=114)andthe control group(n=115).Patients were either given ketotifen furnarate 0.025%or emedasfine 0.05%,administered twice a day for a treatment period of two weeks.The scores for itching and conjanctival hyperemia of both groups were evaluated at baseline,and on treatment days SeVen(primary efficacy endFIoint)and fourteen.ResultsAt day seven and day fourteen.the scores for itching and conjunctival hyperemia in both groups were reduced significantly.All differences from baseline were statistically significant(P<0.05).And there was no significant difference in efficacy between the ketotifen and the emedastine groups(P>0.05).Conclusion The efficacy of imported ketotifen fumarate 0.025%in alleviating ocular itching and conjunctival hyperemia in patients with seasonal allergic conjunctivitis is not inferior to that ofemedastine 0.05%. Key words: Ketotifen; Emedastine; Seasonal allergic conjunctivitis

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