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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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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).
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.
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.
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.
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