December 2002
Volume 43, Issue 13
Free
ARVO Annual Meeting Abstract  |   December 2002
Comparison of a Single Dose of Zaditor® (Ketotifen Fumarate 0.025%) to a Two-Week Regimen of Cromolyn Sodium 4% in Subjects with Allergic Conjunctivitis
Author Affiliations & Notes
  • JV Greiner
    Immunology Schepens Eye Research Inst Boston MA
  • PJ Gomes
    Ophthalmic Research Associates Inc North Andover MA
  • G Minno
    Novartis Ophthalmics Duluth GA
  • Footnotes
    Commercial Relationships    J.V. Greiner, Novartis Ophthalmics F; P.J. Gomes, Novartis Ophthalmics F; G. Minno, Novartis Ophthalmics F.
Investigative Ophthalmology & Visual Science December 2002, Vol.43, 117. doi:
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      JV Greiner, PJ Gomes, G Minno; Comparison of a Single Dose of Zaditor® (Ketotifen Fumarate 0.025%) to a Two-Week Regimen of Cromolyn Sodium 4% in Subjects with Allergic Conjunctivitis . Invest. Ophthalmol. Vis. Sci. 2002;43(13):117.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Abstract: : Purpose: Zaditor® (Ketotifen Fumarate 0.025% Ophthalmic Solution) and Cromolyn Sodium 4% Ophthalmic Solution are two topical anti-allergic medications with different modes of action and efficacy profiles. Zaditor® is indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis. Although indicated in the US for the treatment of VKC, vernal conjunctivitis, and vernal keratitis, Cromolyn is widely used in the management of seasonal allergic conjunctivitis. This study compared the efficacy of these therapies. Method: This was a single-centered, double-masked, randomized, active controlled conjunctival allergen challenge (CAC) clinical trial. At Visit 1 (Day 0) consent was obtained, an ophthalmic exam was performed and increasing concentrations of allergen was instilled bilaterally every 10 minutes to elicit 2.0 ocular itching and hyperemia OU (0-4). Qualified subjects, returned for Visit 2 (Day 7) and the allergen dose that elicited 2.0 itching and hyperemia OU at Visit 1 was instilled bilaterally. Itching was evaluated 7 min after instillation. Hyperemia was evaluated 7 and 15 min after instillation. Qualified subjects (n=59) were given one bottle of masked Cromolyn to instill in one eye and one bottle of masked Placebo in the other eye QID for 14 days. At Visit 3 (Day 21) one drop of Zaditor® was placed in the eyes that had received Placebo QID and one drop of Cromolyn was placed in the QID Cromolyn treated eyes. Fifteen (15) minutes later the allergen dose from Visit 2 was instilled bilaterally. Itching was evaluated 7 min after instillation. Hyperemia was evaluated 7 and 15 min after instillation. Four (4) hours after instillation of Zaditor® and Cromolyn allergen was again administered bilaterally. Itching was evaluated 7 min after instillation. Hyperemia was evaluated 7 and 15 min after instillation. Results: Mean efficacy scores were evaluated for ocular itching and ocular hyperemia. At fifteen (15) minutes and four (4) hours after instillation Zaditor® treated eyes showed less ocular itching (-1.64, p<0.001; -0.81, p<0.001) compared to Cromolyn treated eyes. Zaditor® treated eyes also showed less conjunctival hyperemia compared to Cromolyn fifteen (15) minutes and four (4) hours after instillation. Conclusion: A single dose of Zaditor® (Ketotifen Fumarate 0.025% Ophthalmic Solution) is superior to a 2 week QID treatment of Cromolyn Sodium 4% in preventing the signs and symptoms of allergic conjunctivitis.

Keywords: 357 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 366 conjunctivitis 
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