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T. T. Macejko, E. B. McLaurin, F. K. Kurata, E. J. Meier, M. T. Bergmann, G. L. Torkildsen, J. I. Williams, J. A. Gow, M. B. Abelson, T. R. McNamara; Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Ocular Itching Following Dosing in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis. Invest. Ophthalmol. Vis. Sci. 2009;50(13):6328.
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Bepotastine besilate ophthalmic solution 1.5% is an investigational ocular medication in the United States with selective histamine H1 receptor antagonistic action and stabilization of mast cell function, and inhibitory action on eosinophil infiltration to inflammatory sites. Post hoc assessment of integrated data from two Phase 3 clinical trials examined the efficacy and safety of bepotastine besilate 1.5% compared to placebo in reducing ocular itching using the CAC model at 15 minutes, 8 hours, and 16 hours after ophthalmic dosing.
Two CAC clinical trials (1 single site, 1 multi-site) were each 7 week, masked, randomized, placebo-controlled studies. Eligible subjects were assigned randomly to either bepotastine besilate 1.5% (n=78) or placebo (n=79). Ocular itching was graded on a 0-4 unit scale, with 0.5 unit increments allowed.
Bepotastine besilate ophthalmic solution 1.5% was statistically superior to placebo at a majority of time points at 15 minutes (P<0.0001), 8 hours (P<0.0001), and 16 hours (P<0.0001) after dosing for reducing CAC-induced ocular itching. Discontinued subjects included placebo group subjects (n=8) for non-compliance, and bepotastine besilate ophthalmic solution 1.5% subjects for non-compliance (n=5) or other (n=3). Additional study visits were not needed for any enrolled subjects.
Bepotastine besilate ophthalmic solution 1.5% was statistically superior to placebo in reducing ocular itching in an integrated CAC model of allergic conjunctivitis after ophthalmic dosing. These data support bepotastine besilate ophthalmic solution 1.5% for dosing once or twice daily.
Clinical Trial: :
www.clinicaltrials.gov NCT00586664; NCT00424398
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