Ocular tolerability and safety of ketotifen fumarate ophthalmic solution.

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.

• Authors: Mark B Abelson, Matthew J Chapin, Barry M Kapik, Naveed B K Shams
• Journal: Advances in therapy (Adv Ther) 2002 Jul-Aug Vol. 19 Issue 4 Pg. 161-9 ISSN: 0741-238X [Print] United States
• PMID: 12431041 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Allergic Agents
• Ophthalmic Solutions
• Ketotifen

Topics

• Adult
• Analysis of Variance
• Anti-Allergic Agents (administration & dosage, adverse effects)
• Child
• Child, Preschool
• Conjunctivitis, Allergic (diagnosis, drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Eye (drug effects)
• Female
• Follow-Up Studies
• Headache (chemically induced)
• Humans
• Ketotifen (administration & dosage, adverse effects)
• Male
• Ophthalmic Solutions (adverse effects)
• Probability
• Reference Values
• Statistics, Nonparametric
• Treatment Outcome
• Visual Acuity (drug effects)