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NCT03808688

Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting

Completed Phase 4 Results posted Last updated 29 September 2020
What this trial tests

Phase 4 trial testing Netarsudil Ophthalmic Solution 0.02% in Glaucoma, Open-Angle in 261 participants. Completed in 26 July 2019.

Timeline
27 December 2018
Primary endpoint
26 July 2019
26 July 2019

Quick facts

Lead sponsorAerie Pharmaceuticals
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment261
Start date27 December 2018
Primary completion26 July 2019
Estimated completion26 July 2019
Sites22 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Aerie Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Glaucoma, Open-Angle or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intraocular Pressure (IOP) Primary · 12 weeks

Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry. Prostaglandin analog (PGA). Fixed dose combination (FDC).

GroupValue95% CI
Netarsudil Ophth Sol 0.02% Monotherapy - Tx Naïve At Baseline-16.9± 16.35
Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 1 Agent-2.3± 16.23
Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 2 Agents0.2± 8.81
Netarsudil Ophth Sol 0.02% Concomitant Therapy-17.0± 16.81

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected during the course of the 12-week treatment period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Netarsudil Ophthalmic Solution 0.02% Monotherapy
Serious: 2/99 (2%)
Deaths: 0/99
Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy
Serious: 1/161 (1%)
Deaths: 0/161

Serious adverse events (3 terms)

ReactionSystemNetarsudil Ophthalmic Solu…Netarsudil Ophthalmic Solu…
Cellulitis Lower Left ExtremityInfections and infestations
Malignant Melanoma of EyelidNeoplasms benign, malignant and unspecified (incl cysts and polyps)
PneumoniaInfections and infestations
Other adverse events (4 terms — click to expand)

ReactionSystemNetarsudil Ophthalmic Solu…Netarsudil Ophthalmic Solu…
Conjunctival HyperemiaEye disorders
Vision BlurredEye disorders
Conjunctival HemorrageEye disorders
Instillation Site PainEye disorders

Most-reported serious reactions: Cellulitis Lower Left Extremity, Malignant Melanoma of Eyelid, Pneumonia.

Data from ClinicalTrials.gov NCT03808688 adverse events section.

Sponsor's own description

To evaluate the IOP lowering efficacy of netarsudil ophthalmic solution 0.02% when used as monotherapy or when used concomitantly with other IOP-lowering agents in subjects with elevated IOP due to open angle glaucoma or ocular hypertension in a real-world clinical setting. The study is an open-label design. The patients will receive treatment for 12 weeks.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Rho kinase inhibitor for primary open-angle glaucoma and ocular hypertension.
    Clement Freiberg J, von Spreckelsen A, Kolko M, Azuara-Blanco A, et al · · 2022 · cited 21× · PMID 35686679 · DOI 10.1002/14651858.cd013817.pub2
  2. A multicenter, open-label study of netarsudil for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension in a real-world setting.
    Zaman F, Gieser SC, Schwartz GF, Swan C, et al · · 2021 · cited 17× · PMID 33733980 · DOI 10.1080/03007995.2021.1901222
  3. Connective Tissue Growth Factor: Regulation, Diseases, and Drug Discovery.
    Ren M, Yao S, Chen T, Luo H, et al · · 2024 · cited 10× · PMID 38731911 · DOI 10.3390/ijms25094692
  4. Rho Kinase (ROCK) Inhibitors in the Treatment of Glaucoma and Glaucoma Surgery: A Systematic Review of Early to Late Phase Clinical Trials.
    Tan JK, Khaw PT, Henein C. · · 2025 · cited 3× · PMID 40283958 · DOI 10.3390/ph18040523

Verify or expand the search:

Other trials of Netarsudil Ophthalmic Solution 0.02%

Trials testing the same drug.

Other recruiting trials for Glaucoma, Open-Angle

Currently open trials in the same condition.

Other Aerie Pharmaceuticals trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing