April 2011
Volume 52, Issue 14
ARVO Annual Meeting Abstract  |   April 2011
Ocular Hypotensive Dose-response Efficacy and Safety of the Rho Kinase Inhibitor, K-115, in Patients with Primary Open-angle Glaucoma and Ocular Hypertension
Author Affiliations & Notes
  • Hidenobu Tanihara
    Department of Ophthalmology and Visual Science, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan
  • Haruki Abe
    Division of Ophthalmology and Visual Science, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan
  • Yasuaki Kuwayama
    Fukushima Eye Clinic, Osaka, Japan
  • Tetsuya Yamamoto
    Department of Ophthalmology, Gifu University Graduate School of Medicine, Gifu, Japan
  • Makoto Araie
    Kanto Central Hospital, Tokyo, Japan
  • Footnotes
    Commercial Relationships  Hidenobu Tanihara, Kowa Company, Ltd. (C); Haruki Abe, Kowa Company, Ltd. (C); Yasuaki Kuwayama, Kowa Company, Ltd. (C); Tetsuya Yamamoto, Kowa Company, Ltd. (C); Makoto Araie, Kowa Company, Ltd. (C)
  • Footnotes
    Support  Kowa Company, Ltd.
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 220. doi:
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      Hidenobu Tanihara, Haruki Abe, Yasuaki Kuwayama, Tetsuya Yamamoto, Makoto Araie; Ocular Hypotensive Dose-response Efficacy and Safety of the Rho Kinase Inhibitor, K-115, in Patients with Primary Open-angle Glaucoma and Ocular Hypertension. Invest. Ophthalmol. Vis. Sci. 2011;52(14):220.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : To investigate the efficacy and safety of a Rho kinase inhibitor, K-115, at various concentrations (placebo, 0.1%, 0.2% and 0.4%) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).

Methods: : In this multicenter, prospective, randomized, double-masked, clinical study, 210 patients with POAG or OH were included. Following an appropriate washout period that varied according to previous medication, patients received either K-115 or placebo twice a day at 9:00 and 21:00 for 8 weeks and visited hospitals once every two weeks so as to measure intraocular pressure (IOP) at 9:00, 11:00 and 17:00.

Results: : Baseline of IOP of each dose in this study ranged from 23.0 ± 2.1 (mean ± SD) to 23.4 ± 2.5 mmHg. K-115 0.1%, 0.2% and 0.4 % lowered IOP by -3.4 ± 2.0, -3.2 ± 2.6, and -3.5 ± 1.9 mmHg from baseline at 9:00 of the last visit, while the reduction of placebo was -2.2 ± 2.2mmHg. The largest IOP reductions were achieved at 11:00 (peak) at all of the tested dose, and K-115 0.4% produced the maximum IOP lowering effect of -5.0 ± 2.4 mmHg from baseline, which was statistically significant compared with placebo. Dose dependent IOP lowering effect of K-115 was statistically significant at all of the time points. The reported adverse events in this study were mild to moderate, and the most frequently observed adverse event was mild transient conjunctival hyperemia (65.3% of patients of K-115 0.4%). Only one case of mild conjunctival hemorrhage was reported at the 0.1% dose and considered drug-related.

Conclusions: : K-115, a ROCK inhibitor, statistically significantly lowered IOP in patients with POAG and OH at each point tested, which indicates that it has the potential to be a new agent for glaucoma to control 24-hour IOP by twice daily dosing.

Clinical Trial: : http://www.clinicaltrials.jp/user/ctiMain_e.jsp, 101015

Keywords: intraocular pressure • drug toxicity/drug effects • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials 

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