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Ocular tolerability and safety of ketotifen fumarate ophthalmic solution

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Abstract

Ketotifen fumarate, formulated for the treatment of allergic conjunctivitis, is a histamine H1-receptor antagonist, mast cell stabilizer, and eosinophil inhibitor (decreases chemotaxis and activation of eosinophils). In this study, healthy volunteers 3 years of age or older received ketotifen fumarate .025% ophthalmic solution (n = 330) or placebo (n = 165) four times daily for 6 weeks. Ketotifen was safe and well tolerated in the adult and pediatric populations, with an incidence of ocular adverse events of 18.2%, compared with 15.2% with placebo. No ocular rebound vasodilation or itching was observed within 48 hours after treatment. Ketotifen has a favorable safety and tolerability profile, which may have a positive impact on compliance, an important aspect of effective symptomatic control of allergic conjunctivitis.

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Authors and Affiliations

  1. Schepens Eye Research Institute, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts

    Mark B. Abelson M.D.

  2. Ophthalmic Research Associates, Inc., North Andover, Massachusetts

    Matthew J. Chapin B.S.

  3. Novartis Ophthalmics, Inc., Duluth, Georgia

    Barry M. Kapik M.S. & Naveed B. K. Shams M.D., Ph.D.

Authors
  1. Mark B. Abelson M.D.
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  2. Matthew J. Chapin B.S.
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  3. Barry M. Kapik M.S.
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  4. Naveed B. K. Shams M.D., Ph.D.
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Abelson, M.B., Chapin, M.J., Kapik, B.M. et al. Ocular tolerability and safety of ketotifen fumarate ophthalmic solution. Adv Therapy 19, 161–169 (2002). https://doi.org/10.1007/BF02848691

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  • DOI: https://doi.org/10.1007/BF02848691

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