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A. Salapatek, L. Pozza, D. Patel, P. Patel; Levocetirizine, but Not Montelukast, Is Effective in Alleviating Ocular Symptoms in Allergic Patients Exposed to Ragweed Pollen in an Environmental Exposure Chamber (EEC) Model. Invest. Ophthalmol. Vis. Sci. 2008;49(13):416.
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To report the effects of levocetirizine, an oral antihistamine of the latest generation, and montelukast, an oral leukotriene receptor antagonist, on reducing the severity of ocular symptoms associated with seasonal ragweed allergy in an EEC.
This was a randomized, double-blind, 3-arm parallel, placebo-controlled study in which 403 ragweed-sensitized patients were randomized to placebo (102 patients), levocetirizine 5 mg (152 patients) and montelukast 10 mg (149 patients) and exposed to a controlled level of ragweed pollen in the EEC. Three treatment periods were identified for analyses: Period 1 (treatment day 1 - 0-5h after first drug intake at 11 AM), Period 2 (treatment day 2 - 22.5-24h after first drug intake) and Period 3 (treatment day 2 - 0-4.5h after second drug intake at 11 AM). The primary endpoint was the change from baseline in Major Symptom Complex (MSC) score over Period I, consisting of runny nose, sniffles, itchy nose, nose blows, sneezes, and watery eyes. Among secondary endpoints, the individual symptoms watery eyes and itchy eyes/ears were assessed by patients on a 0-5 scale every 30 minutes during the EEC periods. The reduction from baseline in symptoms was analyzed using ANCOVA.
Peak baseline ocular symptom severity was >2.5 for watery eyes and >3 for itchy eyes/ears. Levocetirizine was significantly superior to placebo in improving watery eyes over all three treatment periods, with mean change ±SD from baseline -0.62±0.07 (p=0.007 vs. placebo), -0.44±0.07 (p=0.014) and -0.79±0.08 (p=0.027), respectively, and over the total treatment period (-0.67±0.07, p=0.003). Similarly, levocetirizine significantly improved itchy eyes/ears as compared to placebo over all treatment periods, with mean change from baseline being -0.73±0.08 (p=0.003), -0.56±0.08 (p=0.002) and -0.94±0.09 (p=0.002), respectively, and over the total treatment period (-0.79±0.07, p<0.001). Unlike levocetirizine, the comparator montelukast did not significantly improve watery eyes or itchy eyes/ears compared to placebo in any individual treatment period; however, montelukast was significant compared to placebo for watery eyes over the total treatment period (p=0.044).
Levocetirizine, but not montelukast, demonstrated significant and consistent efficacy vs. placebo in reducing the severity of watery and itchy eye symptoms in ragweed allergic patients studied in an EEC, an ideal clinical model to test therapeutics for ocular allergy. Funding: UCB
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