[A 10-week safety and efficacy evaluation of olopatadine, 0.2% instilled twice-daily in patients with allergic conjunctivitis in Japan].

PURPOSE: Olopatadine hydrochloride ophthalmic solution, 0.2% (olopatadine 0.2%) is a multi-action agent approved in Japan for allergic conjunctivitis when used as a dose of 1 to 2 drops twice-daily. The objective of this study was to evaluate the long-term (10 weeks) safety and efficacy of olopatadine 0.2% in Japanese patients with allergic conjunctivitis when used as a dose of 2 drops twice-daily. SUBJECTS AND METHODS: This was a single-insititution, open-label, single-group study of symptomatic patients > or = 12 years of age with allergic conjunctivitis. RESULTS: A total of 110 Japanese patients were enrolled. From baseline to week 10, the mean (95% confidence interval) absolute changes were -2.4 (-2.7, -2.2) in ocular itching and the total hyperemia scores were -3.2 (-3.4, -2.9). Mean scores for all other efficacy variables were low at baseline (< or = 2.4) and decreased to < or = 0.6 by week 10. There were no serious adverse events. Mild eye irritation (1 patient) was the only treatment-related event. No safety concerns were identified in a review of the safety results. CONCLUSIONS: Based on this study, olopatadine 0.2% is generally safe, well tolerated and effective when instilled as 2 drops in both eyes twice-daily in Japanese patients with allergic conjunctivitis and is a useful new option for ocular allergy management.