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Accession number;99A0447095
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| Title;Phase III Clinical Study of AG-901 Ophthalmic Solution on Primary Open-Angle Glaucoma and Ocular Hypertension. A Multicenter, Double-blind Comparison with 0.5% Timolol Maleate. |
| Author;
KITAZAWA YOSHIAKI
(Gifu Univ., Sch. of Med.)
AZUMA IKUO
(Osaka Med. Coll.)
SHIRATO SHIROAKI
(Univ. of Tokyo, Fac. of Med.)
TSUKAHARA SHIGEO
(Yamanashi Med. Coll.)
MISHIMA HIROMU
(Hiroshima Univ., Sch. of Med.)
MIZOGAMI KUNIYOSHI
(Mizogamiganka)
OGAWA NOBUYA
(Ehime Univ.)
ODO SHIGEHIRO
(Kyushu Univ., Grad. Sch.)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.15;NO.3;PAGE.525-539(1999)
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| Figure&Table&Reference;TBL.16, REF.8 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;We conducted the multicenter, double-blind comparative clinical study on the 0.5% AG-901(levobunolol hydrochloride) ophthalmic solution in comparison with 0.5% timolol maleate(timolol) in patients with primary open-angle glaucoma or ocular hypertension. In this study, 0.5% AG-901 or 0.5% timolol was topically instilled twice daily for 12 weeks-without washout period-in patients who had been receiving twice-daily instillation of 0.5% timolol for 6 weeks or more. Equivalence test in a handicapped way(.DELTA.=0.05) confirmed the equivalence of IOP levels at the end of instillation between the AG-901 and timolol groups. Mild or moderate adverse reactions were found in 2 of 46 patients(4.3%) in the AG-901 group and in 3 of 46 patients(6.5%) in the timolol group. All these patients recovered in the course of the study. In conclusion, therefore, twice-daily treatment with 0.5% AG-901 is similar in efficacy and safety to twice-daily treatment with 0.5% timolol. (author abst.) |
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