Efficacy and afety of ketotifen fumarate 0.025% in the conjunctival antigen challenge model of ocular allergic conjunctiviti

Purpoe To determine the duration of action of ketotifen 0.025% eye drop v placebo taken a ingle or multiple doe in an allergen challenge model. Deign Two randomized, multicenter, double-maked, contralateral placebo-controlled tudie, one a ingle-doe and one a multiple-doe tudy. Method Two conjunctival provocation tet (CPT) were initially conducted to confirm reproducibility of ubject repone in both tudie. ubject in tudy 1 (n = 87) received ingle doe of ketotifen in one eye and placebo in the other 15 minute, 6 hour, and 8 hour before CPT. ubject in tudy 2 (n = 85) received ketotifen or placebo once 8 hour before CPT. ingle-doe efficacy reult were ued to further qualify a ubject a a reponder. Reponder were re-randomized to a 4-week twice daily doing regimen with a CPT 8 hour after the final doe. In both tudie, ocular ymptom were aeed at three time point 3 to 15 minute after challenge. There were no ignificant difference in advere event between group. Reult For both tudie, ocular itching and vacular injection were ignificantly reduced (P < .003) at all time point after intillation of ketotifen, with a maximum reduction at 7 minute potchallenge. In tudy 2, chemoi, tearing, and lid welling were alo aeed and were ignificantly reduced (P < .008) after intillation of ketotifen. Concluion Ketotifen 0.025% eye drop were afe and tatitically effective in preventing ocular itching, injection, and other ign and ymptom of allergic conjunctiviti at 15 minute, 6 hour, and 8 hour after a ingle doe and at 8 hour after the final doe of a 4-week twice daily regimen.