title: Efficacy and safety of single- and multiple-dose ketotifen fumarate 0.025% ophthalmic solution in a pediatric population.
abstract: Allergic conjunctivitis can seriously disrupt children's daily activities. This study assessed the efficacy (onset and duration of action) and safety of ketotifen fumarate 0.025% ophthalmic solution compared with vehicle placebo in pediatric subjects after single and multiple dosing. This was a double-masked, multicenter, fellow-eye, placebo-controlled, conjunctival allergen challenge trial. Eligible subjects (8-16-yr-olds) who produced a qualifying reaction to allergen were randomized to a single dose (one drop) of ketotifen fumarate in one eye and vehicle placebo in the fellow eye, followed by an allergen challenge at 15 min and 8 h post-dose. Subjects who had a qualifying reaction to allergen in the placebo-treated eye and a qualifying response to ketotifen in the active-treated eye following the single dose were re-randomized to a multiple-dose treatment period. They were instructed to instill one drop of ketotifen fumarate in one eye and placebo in the other eye twice daily for 4 wk. An allergen challenge was conducted 8 h after the last dose. The primary efficacy assessment was ocular itching, judged by the subject at 3, 7, and 10 min post-allergen challenge after single- and multiple-dose treatments. Other ocular signs and symptoms were assessed at 7, 10, and 15 min post-dose. A total of 133 subjects were randomized to single-dose treatment; 105 were evaluable for efficacy. Of these, 60 were re-randomized to multiple-dose treatment, and 55 were evaluable for efficacy. After single and multiple doses, ketotifen fumarate significantly inhibited ocular itching compared with placebo at all post-challenge timepoints (p < 0.001) and also significantly reduced hyperemia, chemosis, and lid swelling (p = 0.031). No drug-related systemic adverse events were reported, and ocular adverse events were comparable to placebo. No subject discontinued prematurely due to an adverse event. These results indicate that ketotifen fumarate 0.025% ophthalmic solution is an effective and safe treatment option for children with allergic conjunctivitis.
authors.affiliation: Schepens Eye Research Institute, Harvard Medical School, Boston, MA 01845, USA. mbabelson@oraclinical.com
authors.forename: Mark B
authors.initials: MB
authors.lastname: Abelson
authors.forename: Nancy J
authors.initials: NJ
authors.lastname: Ferzola
authors.forename: Cecilia L
authors.initials: CL
authors.lastname: McWhirter
authors.forename: Henry J
authors.initials: HJ
authors.lastname: Crampton
mesh_terms: D000293:Adolescent; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007665:Ketotifen / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D009883:Ophthalmic Solutions / Q000009:adverse effects / Q000627:therapeutic use*; D011537:Pruritus / Q000188:drug therapy / Q000209:etiology; D013666:Tears; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D009883:Ophthalmic Solutions; D007665:Ketotifen