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OpenTrials
Completed

NCT Number: NCT03310580

Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension

To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular hypertension in US.

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Key information

Conditions

Primary Open Angle Glaucoma or Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Eye Center, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must be 18 years or older
  • Be of Japanese ethnicity within the 2nd generation defined as (a) 1st generation born in Japan, immigrated to US and (b) 2nd generation - parents are 1st generation and patient was born in US as an American citizen
  • Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
  • Medicated intraocular pressure >/= 15 mmHg and < 30 mmHg in both eyes at screening
  • OAG eyes - unmedicated IOP >/= 15 mmHg and < 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00
  • OHT eyes - unmedicated IOP >/= 22 mmHg and < 35mmHg at 08:00, 10:00 and 16:00
  • Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye
  • Able to give signed informed consent and follow instructions

Exclusion criteria

  • Clinically significant ocular disease
  • Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles
  • Intraocular pressure >/=35 mmHg in either eye
  • Ocular hyperemia score of moderate (+2) at qualification visit #2
  • Previous glaucoma intraocular surgery
  • Refractive surgery in either eye
  • Ocular injury within 6 months prior to screening or ocular surgery or non-refractive laser treatment within 3 months prior to screening
  • Recent or current ocular infection or inflammation in either eye
  • Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study
  • Mean central corneal thickness > 620 µm in either eye
  • Any abnormality preventing reliable applanation tonometry of either eye
  • Known hypersensitivity to benzalkonium chloride or excipients of netarsudil ophthalmic solution
  • Clinically significant abnormalities in screening lab tests
  • Clinically significant systemic disease that might interfere with the study
  • Participated in any investigational study within 30 days prior to screening
  • Systemic medication that could have a substantial effect on IOP within 30 days prior to screening or anticipated during the study
  • Women of child-bearing potential 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

Administered to each eye, once daily (QD) in the evening (PM) for 28 days

AR-13324 Ophthalmic Solution 0.04%

Drug

Administered to each eye, once daily (QD) in the evening (PM) for 28 days

AR-13324 Ophthalmic Solution Placebo

Drug

Administered to each eye, once daily (QD) in the evening (PM) for 28 days

Primary outcomes

  1. Mean Diurnal IOP (Intraocular Pressure) (mmHg)

    Time frame: 28 Days

    Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).

Secondary outcomes

  1. Extent of Exposure

    Time frame: 28 Days

    Exposure to study medication in days for all treatment groups

Sponsors and collaborators

Lead sponsor

Aerie Pharmaceuticals

Industry

Registry information

Official study title

A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety and Ocular Hypotensive Efficacy and Optimum Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension in the United States

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2017
Registry last updated
Dec 23, 2019

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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