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OpenTrials
Completed

NCT Number: NCT02558374

Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aerie Pharmaceuticals

Bedminster, New Jersey, 07921, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Diagnosis of open angle glaucoma or ocular hypertension in both eyes
  • Post-washout intraocular pressure >20mmHg and <30mmHg in 1 or both eyes at 2 qualification visits
  • Corrected visual acuity equivalent to 20/200
  • Able to give informed consent and follow study instructions

Exclusion criteria

  • Clinically significant ocular disease
  • Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
  • Unmedicated intraocular pressure ≥30mmHg
  • Use of more than 2 ocular hypotensive medications within 30 days of screening
  • Known hypersensitivity to any component of the formulation
  • Previous glaucoma surgery or refractive surgery
  • Ocular trauma within 6 months prior to screening
  • Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
  • Recent or current ocular infection or inflammation in either eye
  • Used ocular medication in either eye of any kind within 30 days of screening
  • Mean central corneal thickness >620µm at screening
  • Any abnormality preventing reliable applanation tonometry of either eye
  • Clinically significant abnormalities in lab tests at screening
  • Known hypersensitivity or contraindication to beta-adrenoceptor antagonists
  • Clinically significant systemic disease
  • Participation in any investigational study within 60 days prior to screening
  • Used any systemic medication that could have a substantial effect in intraocular pressure within 30 days prior to screening
  • Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

Treatment and study plan

AR-13324 Ophthalmic Solution 0.02%

Drug

1 drop once daily (QD), PM, OU

Other names: Netarsudil

Timolol Maleate Ophthalmic Solution 0.5% BID

Drug

1 drop BID, AM/PM, OU

Placebo

Other

1 drop QD, AM, OU

Primary outcomes

  1. IOP (Intraocular Pressure)

    Time frame: 3 months

    The primary efficacy outcome is mean IOP

Secondary outcomes

  1. Extent of Exposure

    Time frame: 6 months

    Exposure to study medication in days for all treatment groups

Sponsors and collaborators

Lead sponsor

Aerie Pharmaceuticals

Industry

Registry information

Official study title

A Double-masked, Randomized, Multi-center, Active-controlled, Parallel Group, 6-month Study With a 3-month Interim Analysis Assessing the Ocular Hypotensive Efficacy and Safety of AR-13324 Ophthalmic Solution, 0.02% QD Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 24, 2015
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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