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J.V. Greiner, G.P. Spindel, P.J. Gomes, C.T. Vogelson, D. Amin, M.V. Bergamini, S.M. Robertson; Olopatadine is Effective for the Prevention and Treatment of the Signs and Symptoms of Allergic Conjunctivitis . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3737.
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Purpose: The combined results from two, independent clinical trials were analyzed to assess the overall efficacy, 16 hours post-instillation, of a formulation of olopatadine hydrochloride ophthalmic solution 0.2% (Olopatadine) in the once-daily prevention and treatment of the primary signs and symptoms of allergic conjunctivitis. Methods: In two, double-masked, randomized, placebo-controlled studies involving asymptomatic subjects with a history of allergic conjunctivitis, a total of 57 subjects received Olopatadine in one eye and placebo in the fellow eye. The conjunctival antigen challenge (CAC) model was used to determine efficacy. In both trials, at the first visit, the allergen and titer used to elicit a positive response for ocular itching and redness were identified for each subject. Confirmation of this choice was made at Visit 2. During subsequent visits, test drug was instilled at onset-of-action and 16-hours prior to the antigen challenge. Ocular itching, conjunctival redness, chemosis and lid swelling were evaluated in each eye at 3, 10, and 20 minutes, post-CAC. Results: Post-CAC, Olopatadine was statistically superior (p<0.05) to placebo in alleviating ocular itching and redness at 6 of 6 time-points; chemosis at 5 of 6 time-points; and lid swelling at 3 of 6 time-points. Relative to placebo at the primary assessment time-point, ocular itching scores were reduced by 80% for the onset challenge and by 78% for the 16-hour challenge; conjunctival redness scores were reduced by 35% and 23% for the onset and 16-hour challenges, respectively. Similarly, chemosis was reduced by 54% and 43%, and lid swelling was reduced by 43% and 65%. In these two trials, no serious, related, or unexpected adverse events were reported, and no subject discontinued due to adverse events. Conclusions: The combined results from these two independent trials demonstrate that Olopatadine is safe, well-tolerated, and may be useful when dosed once-daily for the prevention and treatment of the primary signs and symptoms of allergic conjunctivitis.
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