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S.M. Whitcup, M. Abelson, A. Slugg, P. Gomes, R. Bradford, J. Lue, B. Kim, R. Schiffman; Efficacy and Safety of Ophthalmic Epinastine for Treatment of Seasonal Allergic Conjunctivitis . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3729.
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Purpose: We conducted a multi-center, randomized, double-masked, vehicle-controlled clinical trial of safety and efficacy of epinastine HCl 0.05% ophthalmic solution for patients with seasonal allergic conjunctivitis (SAC). Methods: Patients diagnosed with SAC and a positive result from a conjunctival antigen challenge screen were randomly assigned to receive epinastine HCl 0.05% (n=118), levocabastine 0.05% (n=118), or vehicle of epinastine (n=62) administered in both eyes, twice daily for 8 weeks. The primary efficacy end point was ocular itching graded on a scale of 0 (absent) to 4 (extremely severe) during the two seven day periods of maximal pollen counts. Results: Median average worst daily ocular itch scores were 0.45 for epinastine, 0.60 for levocabastine, and 0.85 for vehicle. Epinastine-treated patients reported significantly less ocular itching than patients receiving vehicle (P=0.045). Epinastine ocular itch scores were numerically lower to that of levocabastine, however, the difference was not statistically significant. Biomicroscopy findings, changes in visual acuity, and adverse events did not differ clinically or statistically between treatment groups. Conclusions: Control of SAC ocular itch afforded by epinastine was significantly better than vehicle, and numerically better than levocabastine. Epinastine 0.05% ophthalmic solution was safe and well-tolerated in SAC patients.
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