Efficacy and safety of ketotifen fumarate 0.025% in the conjunctival antigen challenge model of ocular allergic conjunctivitis

Jack V. Greiner, Thomas Mundorf, Harvey Dubiner, John Lonsdale, Richard Casey, Leonard Parver, Barry M. Kapik, Naveed B.K. Shams, Mark B. Abelson

Research output: Contribution to journalArticlepeer-review

26 Scopus citations


PURPOSE: To determine the duration of action of ketotifen 0.025% eye drops vs placebo taken as single or multiple doses in an allergen challenge model. DESIGN: Two randomized, multicenter, double-masked, contralateral placebo-controlled studies, one a single-dose and one a multiple-dose study. METHODS: Two conjunctival provocation tests (CPTs) were initially conducted to confirm reproducibility of subject responses in both studies. Subjects in study 1 (n = 87) received single doses of ketotifen in one eye and placebo in the other 15 minutes, 6 hours, and 8 hours before CPT. Subjects in study 2 (n = 85) received ketotifen or placebo once 8 hours before CPT. Single-dose efficacy results were used to further qualify a subject as a responder. Responders were re-randomized to a 4-week twice daily dosing regimen with a CPT 8 hours after the final dose. In both studies, ocular symptoms were assessed at three time points 3 to 15 minutes after challenge. There were no significant differences in adverse events between groups. RESULTS: For both studies, ocular itching and vascular injection were significantly reduced (P < .003) at all time points after instillation of ketotifen, with a maximum reduction at 7 minutes postchallenge. In study 2, chemosis, tearing, and lid swelling were also assessed and were significantly reduced (P < .008) after instillation of ketotifen. CONCLUSIONS: Ketotifen 0.025% eye drops were safe and statistically effective in preventing ocular itching, injection, and other signs and symptoms of allergic conjunctivitis at 15 minutes, 6 hours, and 8 hours after a single dose and at 8 hours after the final dose of a 4-week twice daily regimen.

Original languageEnglish (US)
Pages (from-to)1097-1105
Number of pages9
JournalAmerican journal of ophthalmology
Issue number6
StatePublished - Dec 2003
Externally publishedYes

ASJC Scopus subject areas

  • Ophthalmology


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