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

December 9, 2019 updated by: Aerie Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Arizona Eye Center
      • Phoenix, Arizona, United States, 85050
        • Arizona Glaucoma Specialists
    • California
      • Azusa, California, United States, 91702
        • Milton M. Hom, OD FAAO FACAAISc
      • Burbank, California, United States, 91506
        • Havana Research Institute
      • Glendale, California, United States, 91204
        • Global Research Management
      • Los Alamitos, California, United States, 90270
        • Southern California Eye Physicians & Surgeons
      • Los Angeles, California, United States, 90041
        • Global Research Foundation
      • Los Angeles, California, United States, 90013
        • East West Eye Institute
      • Los Angeles, California, United States, 90033
        • USC Roski Eye Institute University of Souther California
      • Newport Beach, California, United States, 92663
        • The Eye Research Foundation
      • Pasadena, California, United States, 91105
        • Southern California Eye Physicians Surgeons
      • Petaluma, California, United States, 94954
        • North Bay Eye Associates Inc.
      • Rancho Cordova, California, United States, 95670
        • Martel Eye
      • San Diego, California, United States, 92093
        • University of California
      • San Diego, California, United States, 92122
        • AdvanceMed Clinical Research
      • San Francisco, California, United States, 94105
        • Glaucoma Center of San Francisco
      • Santa Barbara, California, United States, 93110
        • Samsum Clinic
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • MCB Clinical Research Centers LLC
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Clayton Eye Clinical Research, LLC
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Jenkins Eye Care
      • Kailua, Hawaii, United States, 96704
        • Winward Eye Physicians and Eye Surgeons
      • Kailua, Hawaii, United States, 96740
        • Island Eye Care, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • They Eye Care Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • AdvanceMed Clinical Research
      • Las Vegas, Nevada, United States, 89119
        • Emil A. Stein MD Ltd
    • New York
      • New York, New York, United States, 10065
        • Manhattan Eye Ear and Throat Hospital
      • New York, New York, United States, 10003
        • New York Eye Infirmary of Mount Sinai
      • New York, New York, United States, 10016
        • The Shimmyo Group
    • Ohio
      • Marysville, Ohio, United States, 43040
        • Optimed Research
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Glaucoma Consultants and Center for Eye Research, PA
    • Tennessee
      • Maryville, Tennessee, United States, 37803
        • University Eye Specialists
      • Memphis, Tennessee, United States, 38120
        • VRF Eye Speciality Group
    • Texas
      • Lakeway, Texas, United States, 78734
        • Lake Travis Eye and Laser Center
      • Mission, Texas, United States, 78572
        • DCT - Shah Research LLC dba Discovery Clinical Trials
      • Round Rock, Texas, United States, 78681
        • Round Rock Eye Consultants
      • San Antonio, Texas, United States, 78215
        • San Antonio Eye Center
      • San Antonio, Texas, United States, 78229
        • R and R Eye Research LLC
    • Virginia
      • Falls Church, Virginia, United States, 22046
        • Emerson Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Must be 18 years or older
  2. 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
  3. Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
  4. Medicated intraocular pressure >/= 15 mmHg and < 30 mmHg in both eyes at screening
  5. OAG eyes - unmedicated IOP >/= 15 mmHg and < 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00
  6. OHT eyes - unmedicated IOP >/= 22 mmHg and < 35mmHg at 08:00, 10:00 and 16:00
  7. Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye
  8. Able to give signed informed consent and follow instructions

Exclusion Criteria:

  1. Clinically significant ocular disease
  2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles
  3. Intraocular pressure >/=35 mmHg in either eye
  4. Ocular hyperemia score of moderate (+2) at qualification visit #2
  5. Previous glaucoma intraocular surgery
  6. Refractive surgery in either eye
  7. Ocular injury within 6 months prior to screening or ocular surgery or non-refractive laser treatment within 3 months prior to screening
  8. Recent or current ocular infection or inflammation in either eye
  9. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study
  10. Mean central corneal thickness > 620 µm in either eye
  11. Any abnormality preventing reliable applanation tonometry of either eye
  12. Known hypersensitivity to benzalkonium chloride or excipients of netarsudil ophthalmic solution
  13. Clinically significant abnormalities in screening lab tests
  14. Clinically significant systemic disease that might interfere with the study
  15. Participated in any investigational study within 30 days prior to screening
  16. Systemic medication that could have a substantial effect on IOP within 30 days prior to screening or anticipated during the study
  17. Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AR-13324 Ophthalmic Solution 0.02%
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Drug: AR-13324 Ophthalmic Solution 0.02%
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Experimental: AR-13324 Ophthalmic Solution 0.04%
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Drug: AR-13324 Ophthalmic Solution 0.04%
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Placebo Comparator: Placebo Comparator
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Drug: AR-13324 Ophthalmic Solution Placebo
Administered to each eye, once daily (QD) in the evening (PM) for 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Diurnal IOP (Intraocular Pressure) (mmHg)
Time Frame: 28 Days
Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).
28 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Extent of Exposure
Time Frame: 28 Days
Exposure to study medication in days for all treatment groups
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aerie Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nancy Ramirez-Davis, Aerie Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AR-13324-CS205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Open Angle Glaucoma or Ocular Hypertension

Clinical Trials on AR-13324 Ophthalmic Solution 0.02%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings