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H. Tanihara, M. Inatani, M. Honjo, H. Toskushige, J.-I. Azuma, M. Araie; Phase I Clinical Trial on Intraocular Pressure-Lowering Effects and Safety of Topical Administration of a Selective ROCK Inhibitor, SNJ-1656, in Normal Volunteers. Invest. Ophthalmol. Vis. Sci. 2007;48(13):5573.
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To investigate the effects and safety of topical administration of 0.003 to 0.1% SNJ-1656 in healthy male adult volunteers.
Randomized, double-masked, group-comparison, phase I clinical study. In the initial single-dose trial, 45 normal healthy volunteers were randomly subdivided into five groups, which were treated with 0.003%, 0.01%, 0.03%, 0.05%, and 0.1% SNJ-1656 ophthalmic solution (n= 6 in SNJ-1656 and n=3 in placebo in each group) in stepwise fashion. IOP was measured by non-contact tonometry before and at 1, 2, 4, 8, 12, and 24 hours after instillation. In the repeated-instillation trial, 36 normal healthy volunteers were assigned to four groups: 0.05% SNJ-1656 once daily, 0.1% once daily, 0.05% twice daily, or 0.1% twice daily.
Following single instillation of placebo, 0.003%, 0.01%, 0.03%, 0.05% and 0.1% SNJ-1656, IOP reduction from the baseline was -0.91, - 1.18, - 1.48, - 2.20 (p<0.05 vs placebo), - 1.48 and - 1.98 mmHg at 2 hours, and - 0.63, - 0.95, - 1.79, - 2.26 (p<0.01), - 1.95 and - 3.0 (p<0.01) mmHg at 4 hours, respectively. Following repeated instillation of placebo, 0.05% and 0.1% SNJ-1656 once daily, IOP reductions from the baseline on the 7th day were -1.86, -2.78 and -3.70 (p<0.01) mmHg at 2 hours, and - 1.58, - 1.87 and -4.12 (p<0.01) mmHg at 4 hours, respectively. Following repeated instillation of placebo, 0.05% and 0.1% SNJ-1656 twice daily, IOP reductions on the 7th day were - 0.92, - 3.45 (p<0.01) and -2.51 (p<0.05) mmHg at 2 hours, and - 1.19, - 2.87 (p<0.05) and -2.94 (p<0.01) mmHg at 4 hours, respectively. On slit-lamp examination during the trial, there were no significant adverse findings except injection of the bulbar and palpebral conjunctiva following instillation. In addition, no abnormalities were found in blood pressure, pulse, body temperature, or the electrocardiogram.
This clinical study demonstrated that SNJ-1656 ophthalmic solution is a safe topical agent effective in reducing IOP in eyes of healthy volunteers with both single and 7-day administrations, with only topical side effects.
Phase I pharmaceutical trial
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