Advances in Therapy

, Volume 19, Issue 4, pp 185–193 | Cite as

Single dose of ketotifen fumarate .025% vs 2 weeks of cromolyn sodium 4% for allergic conjunctivitis

  • Jack V. Greiner
  • Clifford Michaelson
  • Cecilia L. McWhirter
  • Naveed B. K. Shams


This single-masked, contralateral-eye, active-controlled allergen-challenge study compared ketotifen fumarate .025% and cromolyn sodium 4% ophthalmic solutions in the prevention of ocular itching, tearing, and redness induced by allergen challenge. After a confirmatory conjunctival provocation test (CPT), 56 patients randomly received masked study medication (placebo in one eye, cromolyn in the other eye) four times daily for 2 weeks. At visit 3, patients received one drop of ketotifen in the eye previously treated with placebo and cromolyn in the other eye. Ocular comfort was assessed 30 seconds postinstillation, and a CPT was conducted 15 minutes and 4 hours postinstillation to evaluate ocular itching, tearing, and redness. Forty-seven patients were analyzed for efficacy. At the 15-minute and 4-hour challenges, ketotifen was superior to cromolyn in preventing itching (P<.001) at all assessments and redness (ciliary, conjunctival, and episcleral) (P≤.001 ) at most assessments. Tearing scores were higher in cromolyn-treated eyes than in ketotifen-treated eyes. Patients reported greater comfort in the ketotifentreated than in the cromolyn-treated eye (P= .066). The most common adverse event was burning/stinging with cromolyn. A single dose of ketotifen was superior to a 2-week four-times-daily regimen of cromolyn in alleviating symptoms of allergic conjunctivitis in the conjunctival allergen-challenge model.


allergic conjunctivitis clinical trial ketotifen cromolyn 


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Copyright information

© Health Communications Inc 2002

Authors and Affiliations

  • Jack V. Greiner
    • 1
  • Clifford Michaelson
    • 2
  • Cecilia L. McWhirter
    • 3
  • Naveed B. K. Shams
    • 3
  1. 1.Schepens Eye Research Institute and Department of OphthalmologyHarvard Medical SchoolBoston
  2. 2.Department of Ophthalmology and NeurologyBoston University School of MedicineBoston
  3. 3.Novartis Ophthalmics, Inc.Duluth

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