title: 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.affiliation: Schepens Eye Research Institute, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Mark B
authors.initials: MB
authors.lastname: Abelson
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Chapin
authors.forename: Barry M
authors.initials: BM
authors.lastname: Kapik
authors.forename: Naveed B K
authors.initials: NB
authors.lastname: Shams
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D003233:Conjunctivitis, Allergic / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005123:Eye / Q000187:drug effects*; D005260:Female; D005500:Follow-Up Studies; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007665:Ketotifen / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D009883:Ophthalmic Solutions / Q000009:adverse effects*; D011336:Probability; D012016:Reference Values; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects
chemical_list: D018926:Anti-Allergic Agents; D009883:Ophthalmic Solutions; D007665:Ketotifen