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M.B. Abelson, P.J. Gomes, D.L. Welch, T.A. Pasquine, F.D. Turner, M.V. Bergamini, S.M. Robertson; Olopatadine Reduces Ocular Signs and Symptoms Associated With Allergic Conjunctivitis 16 Hours After Instillation . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3736.
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Purpose: A formulation of olopatadine hydrochloride ophthalmic solution 0.2% (Olopatadine) was evaluated using a conjunctival allergen challenge (CAC) model to determine efficacy and safety up to 16 hours post-dosing. Methods: In a double-masked, randomized, placebo-controlled study involving 92 asymptomatic subjects with a history of allergic conjunctivitis, subjects were randomized to receive Olopatadine in both eyes, or placebo in both eyes, or Olopatadine in one eye and placebo in the fellow eye. At each subject’s first visit, the allergen and titer to be used to elicit a positive CAC response for ocular itching and redness were identified. Confirmation of this choice was made at Visit 2. During Visits 3 and 4, test drug was instilled at onset and 16-hours, respectively, prior to the antigen challenge. Post-CAC, ocular itching was evaluated in both eyes at 3, 5 and 7 minutes, and conjunctival redness, chemosis, and lid swelling were evaluated in both eyes at 10, 15 and 20 minutes. Results: Olopatadine was statistically superior (p<0.05) to placebo in alleviating itching, conjunctival redness and lid swelling at 6 of 6 time-points post-CAC; superior for chemosis at 5 of 6 time-points. At the primary efficacy time-point, ocular itching scores were reduced, relative to placebo, by 83% for the onset challenge and by 63% for the 16-hour challenge. Conjunctival redness scores were reduced, relative to placebo, by 45% and 30% for the onset and 16-hour challenges, respectively. Similarly, lid swelling was reduced by 81% and 61%, and chemosis was reduced by 80% and 49%. No serious, related, or unexpected adverse events were reported, and no subject discontinued due to adverse events. Conclusions: The tested formulation of olopatadine hydrochloride ophthalmic solution (0.2%) was found to be effective in the treatment of the signs and symptoms associated with allergic conjunctivitis for at least 16 hours post-instillation. Olopatadine, dosed once-daily, has a rapid onset-of-action, and a prolonged duration-of-action, and is safe and well-tolerated.
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