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J. Crampton, P.J. Gomes, C.L. McWhirter, M.B. Abelson; Efficacy and Safety of Single- and Multiple-dose Ketotifen Fumarate 0.025% in a Pediatric Population . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3728.
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Purpose: To compare the efficacy (onset and duration of action) and safety of ketotifen fumarate 0.025% ophthalmic solution with vehicle placebo in pediatric subjects after single and multiple doses. Methods: This was a double-masked, multicenter, fellow-eye, placebo-controlled, conjunctival allergen challenge trial. Eligible subjects (8–16 years old) who produced a qualifying reaction to allergen were randomized to 1 drop of ketotifen in 1 eye and placebo in the fellow eye, followed by allergen challenges at 15 minutes and 8 hours postdose. 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 multiple-dose treatment. They instilled 1 drop of ketotifen in 1 eye and placebo in the other eye twice daily for 4 weeks. An allergen challenge was conducted 8 hours after the last dose. The primary efficacy assessment was ocular itching at 3, 7, and 10 minutes post-challenge. Other ocular signs and symptoms were assessed at 7, 10, and 15 minutes post-challenge. Results: A total of 105 subjects were evaluable for single-dose efficacy and 55 for multiple-dose efficacy. Ketotifen significantly inhibited ocular itching (P<0.001) and composite (conjunctival, ciliary, episcleral) hyperemia, chemosis, and lid swelling (P≤0.031) at nearly all post-challenge timepoints. No drug-related systemic adverse events were reported, and ocular adverse events were comparable to placebo. Conclusions: Ketotifen fumarate 0.025% ophthalmic solution is an effective and safe treatment option for children with allergic conjunctivitis.
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