Tanihara 2015a.

Study characteristics
Methods	Study design: randomized controlled trial Study grouping: cross‐over Unit of randomization: participant Total number of participants (eyes) randomized: 28 participants Number of participants (eyes) randomized per group: 28 participants Total number of participants (eyes) lost to follow‐up: 0 participants  Number of participants (eyes) lost to follow‐up per group: 0 participants  Power calculation and sample size consideration reported: no Planned length of follow‐up: 24 hours Actual length of follow‐up: 24 hours How missing outcome data were handled: NA Was the trial single/double/triple‐masked: open‐label Was the trial an equivalence/superiority/non‐inferiority study: equivalence Extracted outcome results were based on ITT/mITT/CC/PP/PT analysis: ITT Duration of washout for each drug class before interventions began: 4 weeks for prostaglandin and BBs; 2 weeks for other IOP‐lowering agents; 5–30 days between cross‐over periods
Participants	Baseline characteristics Group C Female, n (%): 14 (50%) Age, mean: 47 (SD 12) years POAG, n (%): 7 (25%) Number of participants randomized: 8 Inclusion criteria: Japanese men or non‐pregnant women diagnosed with POAG or OHT, aged 20–64 years; untreated or post‐washout IOP levels ≥ 21 mmHg in 1 or both eyes at the screening visit Exclusion criteria: people with ocular disease (other than POAG or OHT) or ocular surgery (other than eyelid surgery performed < 120 days prior to screening); severe visual field defects or with a corrected visual acuity of worse than decimal visual acuity 0.3 (commensurate with 0.5 logMAR); people with IOP ≥ 30 mmHg excluded in terms of safety concerns During the study, participants were prohibited from receiving other IOP‐lowering medications, any ophthalmic medications or steroids, wearing contact lenses and changing dosages of any systemic medications Pretreatment characteristics between groups: not relevant
Interventions	Intervention characteristics Placebo, twice per day (9 a.m. and 9 p.m.) K115 (ripasudil) 0.2%, twice per day (9 a.m. and 9 p.m.)
Outcomes	Primary outcome reported (time points assessed and reported) IOP reduction Other outcomes reported (time points assessed and reported) Safety (ophthalmologic findings and physiologic parameters)
Identification	Sponsorship source: sponsored by Kowa Company, Ltd, Nagoya, Japan. Sponsor participated in study design, conducting the study, data collection, data management, data analysis, review and approval of the manuscript  Country: Japan Setting: 3 clinical pharmacology facilities Online trial registration site: www.clinicaltrials.jp Trial registration #: study no. 090708 Phase of the trial (phase 2/phase 3/unclear): phase 2 Current publication reported findings from > 1 trial: no Year of publication accepted: 2014 Year of study initiation (participants screening, enrollment and treatment): 2009
Notes	A phase 2, cross‐over, 3‐arm trial of ripasudil 0.2%, 0.4% vs placebo. Only data from group C in dosing period 1 (placebo) and 2 (0.2%) are eligible for inclusion.