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J.V. Greiner, M.B. Abelson, P.J. Gomes, C.T. Vogelson, T.A. Pasquine, R.D. Gross, F.D. Turner, M.V. W. Bergamini, S.M. Robertson, Olopatadine 0. 2% Environmental Study Group; Olopatadine 0.2% Reduces the Primary Sign and Symptom of Allergic Conjunctivitis During Peak Pollen Periods . Invest. Ophthalmol. Vis. Sci. 2004;45(13):4854.
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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 daily severity of ocular signs and symptoms. Grass pollen counts were obtained daily from each investigative center. To compare treatment groups, a two–sample t–test was performed on the average diary itching and redness scores for any 14 days, for 14 consecutive days, and for two, non–overlapping 7 consecutive days of highest mean pollen counts at each investigative center. Results: Olopatadine 0.2% is statistically superior to placebo for both itching and redness for any 14 days (p = 0.0039 and p = 0.0117, respectively), for 14 consecutive days (p = 0.0023 and p = 0.0064, respectively), and for two non–overlapping 7 consecutive days (p = 0.0022 and p = 0.0129, respectively) with the highest mean pollen counts by investigator. In addition, the difference between Olopatadine 0.2% and placebo for both itching and redness is statistically significant for 57 of the 70 study days; Olopatadine 0.2% is favored numerically on 69 days for itching and on all 70 days for redness. 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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