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S. Patterson, M.B. Raizman, M. Henderson; Single-Dose Tolerability Comparison of Topical Ketotifen Fumarate vs. Olopatadine HCl in Allergic Conjunctivitis . Invest. Ophthalmol. Vis. Sci. 2003;44(13):682.
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Purpose: This study compared the single-dose tolerability and safety of ketotifen fumarate 0.025% (KE) and olopatadine HCl 0.1% (OL) ophthalmic solutions in subjects with allergic conjunctivitis. Methods: Eligible subjects, at least 12 years old, with a history and current diagnosis of allergic conjunctivitis, were randomized to receive a single dose of ketotifen or olopatadine in both eyes. Subjects assessed ocular tolerability as burning/stinging on a 5-point rating scale (0=none; 4=severe) prior to and 1 minute after dosing. Tolerability was separately analyzed for subjects who had burning/stinging at baseline and those who did not. Safety assessments included adverse event reports and slit-lamp examinations. Results: A total of 92 (46 KE, 46 OL) subjects were enrolled and completed the study. Of these, 75 (37 KE, 38 OL) subjects had symptoms of burning/stinging at baseline and 17 (9 KE, 8 OL) subjects did not. Both treatments were well tolerated. In subjects with baseline symptoms, ketotifen and olopatadine markedly decreased burning/stinging from baseline by 0.99 and 0.72 score units, respectively. There were no statistically significant between-treatment differences at baseline or postdose in either group. There were no adverse events reported in this study and no changes in slit-lamp examinations. Conclusions: The tolerability of ketotifen fumarate 0.025% and olopatadine HCl 0.1% ophthalmic solutions was similar in a population of subjects with a history and current diagnosis of allergic conjunctivitis, regardless of whether or not the subjects exhibited eye discomfort prior to treatment.
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