Single dose of ketotifen fumarate .025% vs 2 weeks of cromolyn sodium 4% for allergic conjunctivitis.
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 < or = .001) at most assessments. Tearing scores were higher in cromolyn-treated eyes than in ketotifen-treated eyes. Patients reported greater comfort in the ketotifen-treated 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.
Greiner
Jack V
JV
Schepens Eye Research Institute and Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA.
Michaelson
Clifford
C
McWhirter
Cecilia L
CL
Shams
Naveed B K
NB
D000328:Adult; D000368:Aged; D003233:Conjunctivitis, Allergic / Q000175:diagnosis / Q000188:drug therapy*; D004205:Cromolyn Sodium / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007665:Ketotifen / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011336:Probability; D012016:Reference Values; D012680:Sensitivity and Specificity; D016037:Single-Blind Method; D016896:Treatment Outcome
D009883:Ophthalmic Solutions; D004205:Cromolyn Sodium; D007665:Ketotifen