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. 2022 Jun 10;2022(6):CD013817. doi: 10.1002/14651858.CD013817.pub2

Asrani 2019 (MERCURY‐1).

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: parallel group
Unit of randomization: participant
Total number of participants (eyes) randomized: 718 participants
Number of participants (eyes) randomized per group: netarsudil: 244, FDC: 238, latanoprost: 236 participants
Number of participants (eyes) lost to follow‐up per group: netarsudil: 43, FDC: 37, latanoprost: 13 participants
Total number of participants (eyes) lost to follow‐up: 93 participants
Power calculation and sample size consideration reported: yes
Planned length of follow‐up: 3 months for efficacy; 12 months for safety
Actual length of follow‐up: 3 months for efficacy; safety outcomes at 12 months were reported separately (Brubaker 2020)
How missing outcome data were handled: Markov Chain Monte Carlo multiple imputation techniques
Was the trial single/double/triple‐masked: double‐masked
Based on the study hypothesis, 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, and 5 days for muscarinic agonists and carbonic anhydrase inhibitors
Participants Baseline characteristics
Netarsudil 0.02%, once per day (p.m.)

  • Female, n (%): 136 (55.7%)

  • Age ≥ 65 years, n (%): 137 (56.1%)

  • POAG, n (%): 186 (76.2%)

  • Time since diagnosis to study entry, mean: 337.6 (SD 350.2) weeks

  • Receiving a glaucoma medication within 30 days of baseline screening, n (%): 183 (75.0%)

  • Duration on current ocular hypotensive therapy, mean: 176.8 (SD 196.2) weeks

  • Number of participants randomized: 244

  • Number of participants analyzed: 244


Latanoprost 0.005%, once per day (p.m.)

  • Female, n (%): 136 (57.6%)

  • Age ≥ 65 years, n (%): 141 (59.7%)

  • POAG, n (%): 180 (76.3%)

  • Time since diagnosis to study entry, mean: 336.5 (SD 356.6) weeks

  • Receiving a glaucoma medication within 30 days of baseline screening, n (%): 165 (69.9%)

  • Duration on current ocular hypotensive therapy, mean: 186.1 (SD 227.8) weeks

  • Number of participants randomized: 236

  • Number of participants analyzed: 236


Netarsudil 0.02%/latanoprost 0.005% (FDC), once per day (p.m.)

  • Female, n (%): 134 (56.3%)

  • Age ≥ 65 years, n (%): 129 (54.2%)

  • POAG, n (%): 174 (73.1%)

  • Time since diagnosis to study entry, mean: 403.0 (SD 451.7) weeks

  • Receiving a glaucoma medication within 30 days of baseline screening, n (%): 182 (76.5%)

  • Duration on current ocular hypotensive therapy, mean: 180.9 (SD 240.7) weeks

  • Number of participants randomized: 238

  • Number of participants analyzed: 238


Overall

  • Female, n (%): 406 (56.5%)

  • Age ≥ 65 years, n (%): 407 (56.7%)

  • POAG, n (%): 540 (75.2%)

  • Time since diagnosis to study entry, mean: 359.0 (SD 389.6) weeks

  • Receiving a glaucoma medication within 30 days of baseline screening, n (%): 530 (73.8%)

  • Duration on current ocular hypotensive therapy, mean: 181.1 (SD 221.8) weeks

  • Number of participants randomized: 718

  • Number of participants analyzed: 718


Inclusion criteria: bilateral OAG or OHT and were aged ≥ 18 years with unmedicated IOP > 20 and < 36 mmHg in both eyes at 8 a.m. at 2 qualification visits (2–7 days apart) and > 17 and < 36 mmHg in both eyes at 10 a.m. and 4 p.m. at the second qualification visit. Patients using ocular hypotensive medications were required to undergo washout before study entry: 4 weeks for PAs and BBs, 2 weeks for adrenergic agonists, and 5 days for muscarinic agonists and carbonic anhydrase inhibitors. BCVA in each eye was +1.0 logMAR or better by ETDRS measurement
Exclusion criteria: treated with > 2 ocular hypotensive medications within 30 days of screening; pseudoexfoliation or pigment dispersion glaucoma; history of iridocorneal angle closure or narrow angles (including previous peripheral iridotomy); previous glaucoma incisional or laser surgery; previous refractive surgery; central corneal thickness > 620 mm; known hypersensitivity or contraindications to netarsudil or latanoprost (or their excipients); with clinically significant ocular disease other than glaucoma in either eye or systemic disease that might interfere with the study; women of child‐bearing potential who were pregnant, breast‐feeding, planning a pregnancy, or not using a medically acceptable form of birth control
Pretreatment differences between groups: baseline demographics were similar across treatment groups
Other description of the overall study population at baseline: in total, 55.3% (397/718) receiving prostaglandin monotherapy, 7.0% (50/718) other monotherapy and 11.6% (83/718) combination therapy
Interventions

  • Netarsudil 0.02%, once per day (p.m.)

  • Latanoprost 0.005%, once per day (p.m.)

  • Netarsudil 0.02%/latanoprost 0.005% (FDC), once per day (p.m.)
Outcomes Primary outcome reported (time points assessed and reported)

  • IOP at 2 weeks, 6 weeks, 3 months


Other outcomes reported (time points assessed and reported)

  • Safety outcomes measures: ocular and systemic adverse events during the 12‐month treatment period
Identification Sponsorship source: funding/support: the MERCURY‐1 study was sponsored by Aerie Pharmaceuticals, Inc., who participated in the design and conduct of the study; the collection, management, analysis and interpretation of data; and the preparation, review and approval of the manuscript. 
Country: USA
Setting: 56 active sites in 21 states
Online trial registration site: ClinicalTrials.gov
Trial registration #: NCT02558400
Current publication reported findings from > 1 trial: no
Phase of the trial (phase 2/phase 3/unclear): phase 3
Year of study initiation (participants screening, enrollment and treatment): 2017
Year of publication accepted: 2019
Notes