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J Crampton, AP Slugg, G Minno; A Comparison of Zaditor® (Ketotifen Fumarate 0.025% Ophthalmic Solution) Versus AlocrilTM (Nedocromil Sodium 2% Ophthalmic Solution) in Preventing Ocular Itching as Induced by the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis . Invest. Ophthalmol. Vis. Sci. 2002;43(13):118.
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Purpose:Zaditor® (Ketotifen Fumarate 0.025% Ophthalmic Solution) and AlocrilTM (Nedocromil Sodium 2% Ophthalmic Solution) are two topical anti-allergic medications with different modes of action and efficacy profiles. Both are indicated for itching. This study compared the efficacy and comfort of these agents. Methods:This was a single-centered, double-masked, randomized, placebo and active controlled conjunctival allergen challenge clinical trial. At Visit 1 (day 0) eligible subjects received increasing concentrations of an allergen in both eyes every 10 minutes until a sufficient reaction was elicited. Qualified subjects returned for Visit 2 (day 7) and the allergen dose that elicited a reaction at visit 1 was instilled and the subjects evaluated their itching every 30 sec for 20 min. Those who responded with 2.0 itching bilaterally at 6/40 time points qualified for Visit 3. At Visit 3 (day21) qualified subjects (n=59) were treated at random with either Zaditor®, AlocrilTM or Placebo in each eye. Five (5) minutes later the allergen dose that confirmed a reproducible response at Visit 2 was instilled bilaterally. Subjects evaluated their ocular itching every 30 seconds for 20 minutes, then chose which therapy they preferred. At Visit 4 (day 35) subjects were treated with the same study medication used at Visit 3. Twelve (12) hours later the allergen used at visits 1, 2, and 3 was administered bilaterally. Subjects evaluated their ocular itching every 30 seconds for 20 minutes, then chose which therapy they preferred. Results:Five (5) minutes and twelve (12) hours after instillation, Zaditor® treated eyes experienced significantly (p<0.05) less ocular itching induced by CAC compared to both AlocrilTM and Placebo treated eyes. AlocrilTM treated eyes showed no statistical or clinical difference from Placebo. Zaditor® treated eyes were statistically more comfortable (P<0.05) than AlocrilTM treated eyes at 1, 2, 5 and 10 minutes after instillation and they showed no difference from Placebo. Based on comfort and subjective efficacy, Zaditor® treated eyes (60%) were preferred twice as much as AlocrilTM or Placebo treated eyes (21%, 19%). Conclusion:Zaditor® was determined to be significantly more comfortable and effective than AlocrilTM 5 minutes and 12 hours after administration.
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