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[Intraocular pressure lowering effect of 0.0015% tafluprost as compared to placebo in patients with normal tension glaucoma: randomized, double-blind, multicenter, phase III study]. [Article in Japanese]

Author(s): Kuwayama Y, Komemushi S; Tafluprost Multi-center Study Group.

Affiliation(s): Department of Ophthalmology, Osaka Koseinenkin Hospital, Japan.

Publication date & source: 2010, Nihon Ganka Gakkai Zasshi. , 114(5):436-43

PURPOSE: To compare the efficacy and safety of 0.0015% tafluprost ophthalmic solution (Tafluprost) with Placebo ophthalmic solution (Placebo) in normal tension glaucoma (NTG). SETTING: Total of 94 patients enrolled in a randomized, double-blind, parallel-group and multicenter study. METHOD: Patients with NTG were randomly assigned to either Tafluprost or Placebo. Both ophthalmic solutions were instilled once a day in the morning for 4 weeks. RESULTS: Mean intraocular pressure (IOP) changes from baseline were -4.0 +/- 1.7 mmHg in Tafluprost administered patients and -1.4 +/- 1.8 mmHg in Placebo administered patients at 4 weeks, with a statistically significant difference (p<0.001). IOP change at 4 weeks, % IOP reduction at 2 and 4 weeks were also significantly greater in Tafluprost than in Placebo. A total of 51.0% in Tafluprost treated group and 8.9% in Placebo treated group reported adverse drug reactions. CONCLUSION: These results indicate that Tafluprost is clinically useful in the treatment of NTG.

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