Bacharach 2015.
| Study characteristics | ||
| Methods |
Study design: randomized controlled trial Study grouping: parallel group Unit of randomization: participant Total number of participants (eyes) randomized: 224 participants Number of participants (eyes) randomized per group: netarsudil 0.01%: 75, netarsudil 0.02%: 72, latanoprost: 77 participants Total number of participants (eyes) lost to follow‐up: 1 participant Number of participants (eyes) lost to follow‐up per group: netarsudil 0.01%: 1, netarsudil 0.02%: 0, latanoprost: 0 participant Power calculation and sample size consideration reported: yes Planned length of follow‐up: 28 days (+ day 29 and day 30) Actual length of follow‐up: 28 days (+ day 29 and day 30) How missing outcome data were handled: unclear Was the trial single/double/triple‐masked: quadruple‐masked (NCT), double‐masked (article) Was the trial an equivalence/superiority/non‐inferiority study: non‐inferiority study Extracted outcome results were based on ITT/mITT/CC/PP/PT analysis: mITT Duration of washout for each drug class before interventions began: prostaglandins: 4 weeks; BBs: 4 weeks; adrenergic agonists (including alfa‐agonists such as brimonidine and apraclonidine): 2 weeks; muscarinic agonists (e.g. pilocarpine), carbonic anhydrase inhibitors (topical or oral): 5 days |
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| Participants |
Baseline characteristics Netarsudil 0.01%, once per day (10–11 p.m.)
Netarsudil 0.02%, once per day (10–11 p.m.)
Latanoprost 0.005%, once per day (10–11 p.m.)
Overall
Inclusion criteria: aged ≥ 18 years; diagnosis of OAG or OHT; unmedicated (post‐washout) IOP ≥ 24 mmHg at 2 eligibility visits (8 hours), 2–7 days apart, and ≥ 22 mmHg at 10 a.m. and 4 p.m. at second qualification visit; if only 1 eye met the IOP criteria it must have been the same eye that met the criteria at all the qualification time points; corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200); able and willing to give signed informed consent and follow study instructions Exclusion criteria: glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. Note: previous laser peripheral iridotomy was NOT acceptable; IOP > 36 mmHg known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics; previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s) (e.g. laser trabeculoplasty); refractive surgery in study eye(s) (e.g. radial keratotomy, photorefractive keratectomy, laser eye surgery, etc.); ocular trauma within past 6 months, or ocular surgery or laser treatment within the past 3 months prior to screening; evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at screening (visit 0), or history of herpes simplex keratitis; ocular medication of any type within 30 days of visit 0, except for (a) ocular hypotensive medications (which must have been washed out according to the provided schedule), (b) lid scrubs (which may have been used prior to, but not after visit 0) or (c) lubricating drops for dry eye (which may have been used throughout the study); clinically significant ocular disease (e.g. 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 (i.e. cup–disk ratio > 0.8); central corneal thickness > 600 µm; any abnormality preventing reliable applanation tonometry of either eye. Systemic: clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening; known hypersensitivity or contraindication to latanoprost; clinically significant systemic disease (e.g. 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 a substantial effect on IOP within 30 days prior to screening, or anticipated during the study; due to the current status of the preclinical safety program, women of child‐bearing potential who were 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 three 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 differences between groups: no significant differences (Table 3) Other description of the overall study population at baseline: none |
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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, Inc. Country: USA Setting: 22 private practice ophthalmology clinics Online trial registration site: ClinicalTrials.gov Trial registration #: NCT01731002 Phase of the trial: phase 2b Current publication reported findings from > 1 trial: no Year of publication accepted: 2014 Year of study initiation (participants screening, enrollment and treatment): 2012 |
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| Notes | 3 severe adverse events were judged not to be related to treatment: 1 pneumonia (latanoprost), 1 influenza and syncope (latanoprost), 1 death from leukemia (netarsudil 0.01%) | |