原発開放隅角緑内障および高眼圧症患者を対象としたラタノプロスト・チモロール配合剤（KP2035）の第Ⅲ相二重盲検比較試験

Phase Ⅲ double-blind study of latanoprost/timolol combination（KP2035）in patients with primary open-angle glaucoma or ocular hypertension

要約　目的：0.005％ラタノプロストと0.5％チモロール配合剤（KP2035）の有効性と安全性の評価と0.005％ラタノプロスト単剤との比較。対象と方法：原発開放隅角緑内障195例と高眼圧94例の計289例を対象とした。Run-in期間としてラタノプロストを4週間点眼した後，KP2035群とラタノプロスト単独群とに無作為に割り付け，1日1回の点眼を8週間行った。Run-in期間終了後の眼圧をベースラインとした。結果：点眼を8週間行った後の眼圧変動は，KP2035群では2.59±2.40mmHg，ラタノプロスト単独群では1.61±2.19mmHgで，両群間に有意差があった（p＜0.001）。KP2035群ではラタノプロスト群よりも眼刺激の発現が多かったが軽度であった。その他の眼局所の有害事象の頻度と程度は両群間でほぼ同程度であった。心・血管系と呼吸器系に有害事象は発生せず，眼科的所見を含め安全性で特に問題になる所見はなかった。結論：開放隅角緑内障と高眼圧症に対し，KP2035はラタノプロストよりも大きな眼圧下降効果を示し，認容性が高いと評価される。

Abstract.　Purpose：To evaluate the efficacy and safety of ophthalmic solution of KP2035 which contains 0.005％ latanoprost and 0.5％ timolol and to compare its effect with 0.005％ latanoprost monotherapy. Cases and Method：This phase Ⅲ study was made on 289 patients consisting of 195 cases of primary open-angle glaucoma and 94 cases of ocular hypertension. All the cases received once-daily instillation of 0.005％ latanoprost for 4 weeks as run-in period. Cases were then randomly assigned to 2 groups. One group received once-daily instillation of KP2035 and the other instillation of latanoprost for 8 weeks. Intraocular pressure（IOP）at the end of run-in period served as baseline. Results：After 8 weeks of instillation,IOP decreased by 2.59±2.40 mmHg in KP2035 group and by 1.61±2.19 mmHg in latanoprost group. The difference was significant（p＜0.001）. Eye irritation was more frequent in KP2035 group but was mild in intensity throughout. Both groups were similar regarding frequency and severity of other ocular adverse events. There were no cardiovascular or respiratory adverse events. Ophthalmic and laboratory examinations showed no significant safety-related findings. Conclusion：KP2035 was well tolerated and showed greater hypotensive effect than latanoprost monotherapy.