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M.B. Abelson, P.J. Gomes, D.L. Welch, T.A. Pasquine, C.T. Vogelson, R.D. Gross, F.D. Turner, M.V. W. Bergamini, S.M. Robertson, Olopatadine 0. 2% Environmental Study Group; Olopatadine 0.2% is Effective for the Once Daily Treatment of the Ocular Signs and Symptoms Associated with Allergic Conjunctivitis . Invest. Ophthalmol. Vis. Sci. 2004;45(13):4824.
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Purpose: A formulation of olopatadine hydrochloride ophthalmic solution (Olopatadine 0.2%) was evaluated in a hybrid environmental study to determine efficacy and safety in patients with seasonal allergic conjunctivitis or rhinoconjunctivitis. Methods: In a double–masked, randomized, placebo–controlled study involving 260 allergic patients, either Olopatadine 0.2% or placebo was instilled by patients into both eyes, once daily for 10 weeks. Throughout the study, patients assessed the frequency of ocular signs and symptoms weekly. Grass pollen counts were obtained daily from each investigative center. Repeated measures analysis of variance was used to compare treatment differences in the slopes for ocular signs and symptoms as a function of pollen counts. Results: Olopatadine 0.2% significantly reduced the effects of pollen on ocular itching (p = 0.0382) and redness (p = 0.0220) relative to placebo. The slopes of the lines predicting pollen effects on ocular itching (slope = 0.008260) and redness (slope = 0.006032) for the Olopatadine 0.2% group were significantly lower than the slopes for the placebo group (slopes = 0.010746 and 0.008569, respectively). The mean scores for itching and redness by visit further demonstrate that Olopatadine 0.2% is statistically superior to placebo at all study visits. No patient discontinued from the study due to a treatment–related adverse event, and no patient suffered a serious adverse event related to therapy. Conclusions: Olopatadine 0.2% ophthalmic solution is safe, well tolerated, and effective when dosed once daily for the treatment of the ocular signs and symptoms of allergic conjunctivitis.
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