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Hidenobu Tanihara, MD; Masaru Inatani, MD; Megumi Honjo, MD; Hideki Tokushige, MS; Junichi Azuma, MD; Makoto Araie, MD

Arch Ophthalmol. 2008;126(3):309-315.

Objective  To investigate the effects and safety of topical administration of an ophthalmic solution of a selective Rho-associated coiled coil-forming protein kinase (ROCK) inhibitor, SNJ-1656, 0.003% to 0.1%, in healthy male adult volunteers.

Design  Randomized, double-masked, group-comparison, phase 1 clinical study. In the initial single-instillation trial, 45 healthy volunteers were randomly subdivided into 5 groups and treated with SNJ-1656 in concentrations of 0.003%, 0.01%, 0.03%, 0.05%, and 0.1% in stepwise fashion. In the repeated-instillation trial, 36 healthy volunteers were assigned to receive SNJ-1656 ophthalmic solution at the following concentrations and dosages: 0.05% once daily, 0.1% once daily, 0.05% twice daily, or 0.1% twice daily. In our studies, the administration of the solution and subsequent examinations (including intraocular pressure [IOP] measurements) were performed in a double-masked fashion.

Results  After single instillation of placebo or SNJ-1656, in concentrations of 0.003%, 0.01%, 0.03%, 0.05%, and 0.1%, the changes in IOP from the baseline were –0.91, –1.18, –1.48, – 2.20 (P = .04 vs placebo), –1.48, and –1.98 mm Hg, respectively, at 2 hours, and –0.63,–0.95, –1.79, –2.26 (P = .01 vs placebo), –1.95, and –3.00 mm Hg (P <  .001 vs placebo) respectively, at 4 hours. Significant IOP reductions after repeated instillation were also found. On slitlamp examination during the trial, there were no significant adverse findings except hyperemia of the bulbar and palpebral conjunctiva after instillation.

Conclusion  This clinical study demonstrated that SNJ-1656 is a safe topical agent effective in reducing IOP in human eyes.

Author Affiliations: Department of Ophthalmology and Visual Science, Kumamoto University Graduate School of Medical Sciences, Kumamoto (Drs Tanihara and Inatani), Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto (Dr Honjo), Senju Pharmaceutical Co, Ltd (Mr Tokushige), and Clinical Evaluation of Medicine and Therapeutics, Graduate School of Pharmaceutical Sciences and Medicine, Osaka University, Suita (Dr Azuma), Osaka, and Department of Ophthalmology Graduate School of Medicine, University of Tokyo, Tokyo (Dr Araie), Japan.

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