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Efficacy and safety of single‐ and multiple‐dose ketotifen fumarate 0.025% ophthalmic solution in a pediatric population
Author(s) -
Abelson Mark B.,
Ferzola Nancy J.,
McWhirter Cecilia L.,
Crampton Henry J.
Publication year - 2004
Publication title -
pediatric allergy and immunology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.269
H-Index - 89
eISSN - 1399-3038
pISSN - 0905-6157
DOI - 10.1111/j.1399-3038.2004.00146.x
Subject(s) - medicine , ketotifen , placebo , allergic conjunctivitis , randomized controlled trial , dosing , allergen , anesthesia , allergy , immunology , asthma , pathology , alternative medicine
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.