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Makoto Araie, Tuyen Ong, Baldo Scassellati-Sforzolini, Quintus Ngumah, Jason L Vittitow, Robert N Weinreb; Efficacy of Latanoprostene Bunod Ophthalmic Solution, 0.024%, in Lowering Intraocular Pressure Over 24-Hours in Normal Japanese Subjects (KRONUS). Invest. Ophthalmol. Vis. Sci. 2014;55(13):548.
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To evaluate the effect of latanoprostene bunod, 0.024% in reducing and maintaining IOP over 24 hours in normal Japanese subjects. In Phase 2 dose-ranging studies in USA (VOYAGER) and Japan, 0.024% latanoprostene bunod was the safest and most efficacious dose, demonstrating significantly greater IOP reduction compared with latanoprost, 0.005%.
This was a single-arm, single-center, open-label, clinical study of 24 healthy Japanese male volunteers. A baseline IOP profile was established in both eyes in the sitting position at 8 PM, 10 PM, 12 AM, 2 AM, 4 AM, 8 AM, 10 AM, 12 PM and 4 PM using a Goldmann applanation tonometer. Following the baseline visit, both eyes were treated with 0.024% latanoprostene bunod QD at approximately 8 PM for 14 days. For each subject's right eye, the change and change from baseline in sitting IOP at each time point was assessed on Day 14. A one-sampled paired t-test was used to determine statistical significance.
The mean age of the volunteers was 26.8 (range 20-39) years. Mean IOPs (± SD) on Day 0 were: 14.4mmHg (1.7), 13.9mmHg (1.5), 13.4mmHg (1.4), 13.0mmHg (1.3), 13.2mmHg (1.6), 14.0mmHg (1.7), 13.7mmHg (1.5), 13.5mmHg (1.7) and 13.4mmHg (1.6) with a 24-hour mean IOP of 13.6 mmHg (1.6). On Day 14 pressures were: 11.5mmHg (1.8), 9.8mmHg (1.4), 9.8mmHg (1.2), 9.9mmHg (1.2), 9.9mmHg (1.5), 9.8mmHg (1.7), 9.6mmHg (1.3), 9.4mmHg (1.3) and 10.1mmHg (1.1) with a 24-hour mean IOP of 10.0 mmHg (1.5). Intraocular pressures were taken at 8 PM, 10 PM, 12 AM, 2 AM, 4 AM, 8 AM, 10 AM, 12 PM and 4 PM, respectively. 14-day QD treatment with 0.024% Latanoprostene bunod reduced IOP at all time points (p < 0.001) with a mean 24-hour reduction of 3.6mmHg (1.5) or 26% from the baseline. Peak and trough IOP lowering occurred at 8 AM and 8 PM (12 and 24 hours following instillation) with a mean reduction of 4.2mmHg (1.8) or 30% and 2.8mmHg (2.2) or 20%, respectively. No significant adverse events were encountered.
Latanoprostene bunod, 0.024% dosed QD for 14 days significantly lowered IOP in normal Japanese subjects during the entire 24 hour period from 13.6 to 10.0 mmHg, corresponding to 27% reduction in mean 24-hour IOP. The current result suggests potential of this compound in providing sustained 24-hour IOP reduction to glaucoma patients not only with elevated, but also with normal IOP.
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