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P. Arriola Villalobos, J. Sanchez-Lopez, D. Díaz-Valle, N. Alejandre-Alba, S. Vazquez-Cortes, M. Ariño-Gutierrez, T. Robledo-Echarren, J. Benitez-del-Castillo; Comparison of the Clinical Efficacy of Epinastine Hydrochloride 0.05% Ophthalmic Solution and Olopatadine Hydrochloride 0.1% Ophthalmic Solution in the Conjunctival Allergen Challenge Model. Invest. Ophthalmol. Vis. Sci. 2007;48(13):2298.
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The objetive of this study is to compare the efficacy of epinastine hydrochloride versus olopatadine hydrochloride in the conjunctival allergen challenge (CAC) model.
This is a prospective,randomized,double-masked,contralaterally controlled,single-center,4-visit,allergen-challenge study. Elegible participants were asymptomatic but had a history of allergic conjunctivitis and had positive CAC reactions(at least moderate grade 2 ocular ithching and conjunctival redness response in both eyes) at the screening visit and at the confirmation visit.In visit 3,patients were randomly assigned to receive epinastine hydrochloride 0.05% ophthalmic solution in one eye and olopatadine hydrochloride 0.1% ophthalmic solution in the contralateral eye.Five minutes after study drop instillation(onset challenge),subjects were bilaterally challenged with the allergen concentration that had elicited a positive conjunctival allergic response at visits 1 and 2.Allergic signs and symptoms(itching, redness, chemosis, tearing and eyelid swelling) were then evaluated at 3 min,5 min,7 min,10 min and 15 min postchallenge.In visit 4,allergen challenge was made 12 hours after topical drug administration(duration challenge),with the same evaluation as in visit 3.Mean signs and symptoms scores for both eyes at each time point,besides a global number resulting from add all scores,were compared using Wilcoxon test.
Nine patients (5 females,4 males;mean [SD] age 33.3 [10.65] years [range, 18-49 years]) completed the study.There were no statistically significant differences between the two drugs in both the onset and duration challenge, except in redness at 7 min(p=0.035) and global number at 10 min(p=0.04) in onset challenge.
In this population,olopatadine was no significantly more effective than epinastine in controlling signs and symptoms associated with allergic conjunctivitis,except one sign (redness) in one time point.
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