Details

Autor(en) / Beteiligte

• Tanihara, Hidenobu
• Inoue, Toshihiro
• Yamamoto, Tetsuya
• Kuwayama, Yasuaki
• Abe, Haruki
• Fukushima, Atsuki
• Suganami, Hideki
• Araie, Makoto
• Uchino, Miki
• Iwasaki, Miki
• Ono, Koichi
• Sekiyama, Eiichi
• Takahashi, Yoshinori
• Fujie, Keiko
• Shin, Hideyo
• Kaneko, Taku
• Shiba, Hiroharu
• Ijuin, Nobuo
• Tani, Emiko
• Manabe, Yoichi
• Yamana, Yasuo
• Arai, Mikki
• Kurata, Yoshinori
• Shirao, Makoto
• Inoue, Kenji
• Ono, Ryuichiro
• Matsumoto, Jun
• Hatano, Hiroshi
• Ouchi, Keiko
• Kitagawa, Atsuko
• Mizote, Hideaki
• Kato, Hitoshi
• Wakiyama, Harumi
• Migita, Masayoshi
• Hashida, Setsuko
• Kawabata, Hidehito
• Shimizu, Kiyoshi
• Yamabayashi, Shigeki
• Sugiura, Torao
• Kubota, Yasutaka
• Taguchi, Koji
• Miyata, Kazunori
• Ohtani, Shinichiro

Titel

One‐year clinical evaluation of 0.4% ripasudil (K‐115) in patients with open‐angle glaucoma and ocular hypertension

Ist Teil von

• Acta ophthalmologica (Oxford, England), 2016-02, Vol.94 (1), p.e26-e34

Ort / Verlag

England: Wiley Subscription Services, Inc

Erscheinungsjahr

2016

Quelle

Wiley Online Library - AutoHoldings Journals

Beschreibungen/Notizen

• Purpose To investigate the intra‐ocular pressure (IOP)‐lowering effects and safety of 0.4% ripasudil (K‐115), a Rho kinase inhibitor, twice daily for 52 weeks, in patients with open‐angle glaucoma or ocular hypertension (OHT). Methods In this multicentre, prospective, open‐label study, 388 patients with primary open‐angle glaucoma, OHT or exfoliation glaucoma were enrolled and 354 of them were subdivided into four cohorts (monotherapy, 173; additive therapy to prostaglandin analogs, 62; β‐blockers, 60; or fixed combination drugs, 59). The IOP reduction at trough and peak from baseline and adverse events was investigated. Results Ripasudil showed IOP‐lowering effects over 52 weeks in all the analyses of monotherapy, additive therapy and both subgroups (baseline IOP ≥21 mmHg and <21 mmHg) of monotherapy. The mean IOP reductions at trough and peak at week 52 were −2.6 and −3.7 mmHg for monotherapy, and −1.4 and −2.4, −2.2 and −3.0, and −1.7 and −1.7 mmHg, respectively, for additive therapy described above. The most frequently observed adverse events were conjunctival hyperaemia (n = 264, 74.6%), blepharitis (n = 73, 20.6%) and allergic conjunctivitis (n = 61, 17.2%). Most of the conjunctival hyperaemia findings were mild (97.0%), transient and resolved spontaneously (78.0%). Although 51 patients discontinued from the study due to blepharitis and/or allergic conjunctivitis (blepharitis, 28; allergic conjunctivitis, 17; both, 6), all the events resolved with or without treatment after the discontinuation of ripasudil administration. Conclusion Fifty‐two week administration of 0.4% ripasudil revealed IOP‐lowering effects and an acceptable safety profile when administered as monotherapy or as additive therapy, in patients with open‐angle glaucoma or OHT.