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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.
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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.
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.
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.
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.
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