Intra‐ocular pressure‐lowering effects of a Rho kinase inhibitor, ripasudil (K‐115), over 24 hours in primary open‐angle glaucoma and ocular hypertension: a randomized, open‐label, crossover study
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Intra‐ocular pressure‐lowering effects of a Rho kinase inhibitor, ripasudil (K‐115), over 24 hours in primary open‐angle glaucoma and ocular hypertension: a randomized, open‐label, crossover study
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<jats:title>Abstract</jats:title><jats:sec><jats:title>Purpose</jats:title><jats:p>To investigate the intra‐ocular pressure (<jats:styled-content style="fixed-case">IOP</jats:styled-content>)‐lowering effects of a selective Rho kinase inhibitor, ripasudil (K‐115), over 24 hr in patients with primary open‐angle glaucoma (<jats:styled-content style="fixed-case">POAG</jats:styled-content>) or ocular hypertension (<jats:styled-content style="fixed-case">OHT</jats:styled-content>).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>In this multicenter, prospective, randomized, open‐label, 3‐period, Latin‐square crossover clinical study, 28 patients with <jats:styled-content style="fixed-case">POAG</jats:styled-content> or <jats:styled-content style="fixed-case">OHT</jats:styled-content> whose <jats:styled-content style="fixed-case">IOP</jats:styled-content> level was 21 mmHg or higher were subdivided into three groups. Each patient was treated with placebo and ripasudil in concentrations of 0.2 and 0.4%, at 9:00 and 21:00 on day 1 through a total of 3 periods separated by washout periods. <jats:styled-content style="fixed-case">IOP</jats:styled-content> was measured at 9:00, 10:00, 11:00, 13:00, 16:00, 19:00, 21:00, 22:00 and 23:00 on day 1, and 1:00, 4:00, 7:00 and 9:00 on day 2 in sitting position using Goldmann applanation tonometer. Main outcome measure was the <jats:styled-content style="fixed-case">IOP</jats:styled-content> reduction of placebo and ripasudil from baseline.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The mean <jats:styled-content style="fixed-case">IOP</jats:styled-content> reduction was −5.2 mmHg for 0.2%, −6.4 mmHg for 0.4% and −2.0 mmHg for placebo at 2 hr after the first instillation. Also, the corresponding values were −6.8 mmHg for 0.2%, −7.3 mmHg for 0.4% and −4.1 mmHg for placebo at 2 hr after the second instillation. Statistically significant <jats:styled-content style="fixed-case">IOP</jats:styled-content> reduction, compared with placebo, was found for both 0.2 and 0.4% from 1 through 7 hr after each instillation. In safety, conjunctival hyperaemia was observed in 22 patients (79%) for 0.2%, 27 patients (96%) for 0.4% and three patients (11%) for placebo.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Ripasudil is a promising new topical medication to lower <jats:styled-content style="fixed-case">IOP</jats:styled-content> for at least 7 hr after instillations in patients with <jats:styled-content style="fixed-case">POAG</jats:styled-content> or <jats:styled-content style="fixed-case">OHT</jats:styled-content>.</jats:p></jats:sec>