Peace 2021.

Study characteristics
Methods	Study design: randomized controlled trial Study grouping: parallel group Unit of randomization: participant Total number of participants (eyes) randomized: 12 participants Number of participants (eyes) randomized per group: placebo: 8, netarsudil 0.02%: 4 participants Total number of participants (eyes) lost to follow‐up: 0 participants Number of participants (eyes) lost to follow‐up per group: placebo: 0, netarsudil 0.02%: 0 participants Power calculation and sample size consideration reported: yes Planned length of follow‐up: 7 days Actual length of follow‐up: 7 days How missing outcome data were handled: unclear Was the trial single/double/triple‐masked: double‐masked (article), quadruple‐masked (NCT) Was the trial an equivalence/superiority/non‐inferiority study: superiority 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 PAs and BBs; 2 weeks for adrenergic agonists (including alfa‐agonists); or 5 days for muscarinic agonists and carbonic anhydrase inhibitors (topical or oral formulations)
Participants	Baseline characteristics Placebo Female, n (%): 2 (50%) Age, mean: 64.5 (SD 5.07) years Age ≥ 65 years, n (%): 3 (75%) POAG, n (%): 3 (75%) Time since diagnosis to study entry, mean: 447.8 (SD 265.05) weeks Duration on current ocular hypotensive therapy, mean: 48.3 (SD 50.91) weeks Number of participants randomized: 4 Number of participants analyzed: 4 Netarsudil 0.02%, once per day (8‐10 p.m.) Female, n (%): 4 (50%) Age, mean: 64.4 (SD 10.23) years Age ≥ 65 years, n (%): 5 (62.5) POAG, n (%): 8 (100%) Time since diagnosis to study entry, mean: 356.4 (SD 342.39) weeks Duration on current ocular hypotensive therapy, mean: 71.3 (SD 141.95) weeks Number of participants randomized: 8 Number of participants analyzed: 8 Overall Female, n (%): 6 (50%) Age, mean: 64.4 (SD 8.58) years Age ≥ 65 years, n (%): 8 (66.7%) POAG, n (%): 11 (91.7%) Time since diagnosis to study entry, mean: 386.8 (SD 309.49) weeks Receiving a glaucoma medication within 30 days of baseline screening, n (%): 10 (83.3%) Duration on current ocular hypotensive therapy, mean: 62.1 (SD 110.45) weeks Number of participants randomized: 12 Number of participants analyzed: 12 Inclusion criteria: aged ≥ 18 years; ocular hypertension or OAG in both eyes; unmedicated IOP > 17 mmHg in 1 or both eyes and < 30 mmHg in both eyes; corrected visual acuity in each eye equivalent to 20/200 or better; able and willing to give signed informed consent and follow study instructions Exclusion criteria: glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles; IOP ≥ 30 mmHg; use of ocular medications within 30 days; known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination; previous eye surgery (other than cataract); ocular trauma within 6 months; clinically significant ocular disease that might interfere with the study; central corneal thickness > 620 µm Pretreatment characteristics between groups: no statistical comparisons reported (Table 2) Other description of the overall study population at baseline: women and men were equally distributed in each treatment group, there were more participants aged ≥ 65 years (66.7%) than < 65 years (33.3%), and a higher percentage of participants were black or African American (75.0%) than any other race (25.0%)
Interventions	Placebo Netarsudil 0.02%, once per day (8–10 p.m.)
Outcomes	Primary outcome reported (time points assessed and reported)  Mean change from baseline in mean nocturnal IOP (defined as mean of 4 nocturnal time points: 9 p.m., 0 midnight, 3 a.m. and 6 a.m.) at day 8/day 9 Other outcomes reported (time points assessed and reported) Mean change from baseline in mean diurnal IOP (defined as mean of 4 diurnal time points: 9 a.m., 12 noon, 3 p.m., 6 p.m.) at day 8/day 9 Mean change from baseline in mean 24‐hour IOP (defined as the mean of all 8 time points) at day 8/day 9 Mean change from baseline IOP at each post‐treatment time point at day 8/day 9 Mean IOP at each post‐treatment time point at day 8/day 9 Systemic and ocular safety
Identification	Sponsorship source: Aerie pharmaceuticals Country: USA Setting: single‐center Comments: IOP data: mean nocturnal IOP from NCT report; cup–disc ratio Online trial registration site: ClinicalTrials.gov Trial registration #: NCT02874846 Phase of the trial (phase 2/phase 3/unclear): phase 2 Current publication reported findings from > 1 trial: no Year of publication accepted: 2020 Year of study initiation (participants screening, enrollment and treatment): 2016
Notes