April 2011
Volume 52, Issue 14
ARVO Annual Meeting Abstract  |   April 2011
Efficacy and Safety of the Rho Kinase Inhibitor, K-115, over 24 Hours in Patients with Primary Open-angle Glaucoma and Ocular Hypertension
Author Affiliations & Notes
  • Tetsuya Yamamoto
    Department of Ophthalmology, Gifu Univ Graduate Sch of Med, Gifu-shi, Japan
  • Haruki Abe
    Ophthalmology, Niigata Univ Sch of Medicine, Niigata-shi, Japan
  • Yasuaki Kuwayama
    Fukushima Eye Clinic, Osaka, Japan
  • Hidenobu Tanihara
    Ophthalmology & Visual Science, Kumamoto Univ Grad Sch of Med, Kumamoto, Japan
  • Makoto Araie
    Kanto Central Hospital, Tokyo, Japan
  • Footnotes
    Commercial Relationships  Tetsuya Yamamoto, Kowa Company Ltd. (C); Haruki Abe, Kowa Company Ltd. (C); Yasuaki Kuwayama, Kowa Company Ltd. (C); Hidenobu Tanihara, Kowa Company Ltd. (C); Makoto Araie, Kowa Company Ltd. (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 216. doi:
  • Views
  • Share
  • Tools
    • Alerts
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Tetsuya Yamamoto, Haruki Abe, Yasuaki Kuwayama, Hidenobu Tanihara, Makoto Araie; Efficacy and Safety of the Rho Kinase Inhibitor, K-115, over 24 Hours in Patients with Primary Open-angle Glaucoma and Ocular Hypertension. Invest. Ophthalmol. Vis. Sci. 2011;52(14):216.

      Download citation file:

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

  • Supplements

Purpose: : To investigate the efficacy and safety of a new Rho kinase inhibitor, K-115, over 24 hours in primary open-angle glaucoma (POAG) patients and ocular hypertension (OH) patients.

Methods: : In this multicenter, prospective, randomized, open-label, 3-period, Latin-square crossover study, 28 patients diagnosed either POAG or OH were enrolled. Patients were randomly assigned to 3 groups following a planned washout period, and received each of K-115 0.2%, 0.4% or placebo twice a day at 9:00 and 21:00 in each dosing period separated by a sufficient washout period. Intraocular pressure (IOP) was measured at the following 11 time points : 9:00, 10:00, 11:00, 13:00, 16:00, 19:00, 21:00, 22:00, 23:00, 1:00, 4:00, 7:00, 9:00.

Results: : Baseline IOP of each dosing period ranged from 20.3 ± 3.7 (mean ± SD) to 20.9 ± 3.9 mmHg. The largest mean IOP reduction from baseline was observed 2 hours after the instillation at each dose level. IOP of patients on K-115 0.4% treatment decreased by -6.4 ± 2.0 mmHg at 11:00 and -4.3 ± 2.2 mmHg at 21:00 over 12 hours in the first administration, and the analogue fashion of IOP reduction was seen in the second administration at night. Similarly, K-115 0.2% developed the IOP reduction of -5.3 ± 2.3 mmHg at 11:00 and -4.2 ± 2.4 mmHg at 21:00. No severe adverse events were reported in this study. The only adverse event of note was conjunctiva hyperemia seen in all patients but the degree of hyperemia was mild and transient.

Conclusions: : The 3-period, Latin-square crossover study with 11 different time points demonstrated the IOP reduction of K-115 over 24 hours, and indicated that 0.4% of K-115 would be the optimal clinical dose to be studied in the subsequent clinical program.

Clinical Trial: : http://www.clinicaltrials.jp/user/ctiMain_e.jsp, JapicCTI-090708

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

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.