Kahook 2019 (ROCKET‐2).
| Study characteristics | ||
| Methods |
Study design: randomized controlled trial Study grouping: parallel group Unit of randomization: participant Total number of participants (eyes) randomized: 756 participants Number of participants (eyes) randomized per group: netarsudil 0.02% once per day: 251, netarsudil 0.02% twice per day: 254, timolol: 251 participants Total number of participants (eyes) lost to follow‐up: 124 participants Number of participants (eyes) lost to follow‐up per group: netarsudil 0.02% once per day: 46, netarsudil 0.02% twice per day: 101, timolol: 14 participants Power calculation and sample size consideration reported: yes Planned length of follow‐up: primary outcome at 3 months; safety outcomes at 12 months Actual length of follow‐up: primary outcome at 3 months; safety outcomes at 12 months 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: non‐inferiority Extracted outcome results were based on ITT/mITT/CC/PP/PT analysis: NCT: the PP population included all participants who did not have a major protocol violation likely to seriously affect the primary outcome of the study Duration of washout for each drug class before interventions began: 28 days for BBs, prostaglandins and the dorzolamide‐timolol fixed combination; 14 days for alfa‐ and alfa/beta‐agonists, 5 days for miotics and oral or topical carbonic anhydrase inhibitors, and 3 days if participants were receiving no IOP‐lowering therapy |
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| Participants |
Baseline characteristics Netarsudil 0.02%, once per day (p.m.)
Netarsudil 0.02%, twice per day
Timolol 0.5%, twice per day
Overall
Inclusion criteria: 0–2 years of age and ≥ 18 years; diagnosis of OAG or OHT; unmedicated (post‐washout) IOP > 20 mmHg and < 27 mmHg in the study eye at 2 qualification visits; corrected visual acuity in each eye equivalent to 20/200; able and willing to give signed informed consent (parent or guardian consent for children) and follow study instructions Exclusion criteria: glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: previous laser peripheral iridotomy is NOT acceptable; IOP ≥ 27 mmHg (unmedicated) in both eyes or use of > 2 ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as 2 medications; known hypersensitivity to any component of the formulations to be used (benzalkonium chloride, etc.), to topical anesthetics or BBs; previous glaucoma intraocular surgery or glaucoma laser procedures in either eye; refractive surgery in either eye; ocular trauma in either eye within the 6 months prior to screening, or ocular surgery or non‐refractive laser treatment within the 3 months prior to screening; recent or current evidence of ocular infection or inflammation in either eye; current evidence of clinically significant blepharitis, conjunctivitis or a history of herpes simplex or zoster keratitis at screening in either eye; ocular medication in either eye of any type within 30 days of screening; clinically significant ocular disease in either eye (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for 1 month is not judged safe; central corneal thickness in either eye > 600 µm at screening; any abnormality in either eye preventing reliable applanation tonometry of either eye. Systemic: clinically relevant abnormalities (as determined by the investigator) in laboratory tests at screening which may impact the study; known hypersensitivity or contraindication to BBs (e.g. chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third‐degree heart block or congestive heart failure; severe diabetes); clinically significant systemic disease (e.g. uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study; participation in any investigational study within 30 days prior to screening; changes of systemic medication that could have an effect on IOP within 30 days prior to screening, or anticipated during the study; women of child‐bearing potential who are pregnant, breast‐feeding, planning a pregnancy or not using a medically acceptable form of birth control. An adult woman was considered of child‐bearing potential unless she was 1 year postmenopausal or 3 months postsurgical sterilization. All females of child‐bearing potential must have had a negative urine pregnancy test result at the screening examination and must not have intended to become pregnant during the study Pretreatment characteristics between groups: no statistically significant differences in demographics between treatment groups Other description of the overall study population at baseline: not reported |
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| Interventions |
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| Outcomes |
Primary outcome reported (time points assessed and reported)
Other outcomes reported (time points assessed and reported)
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| Identification |
Sponsorship source: Aerie Pharmaceuticals Country: USA Setting: multicenter (62 clinical trial sites) Online trial registration site: ClinicalTrials.gov Trial registration #: NCT02207621 Phase of the trial (phase 2/phase 3/unclear): phase 3 Current publication reported findings from > 1 trial: no Year of publication accepted: 2019 Year of study initiation (participants screening, enrollment and treatment): 2014 |
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| Notes | Primary efficacy data of ROCKET‐2 at 3 months were reported in Serle 2018; safety data of ROCKET‐2 at 12 months in Kahook 2019. | |