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

September 8, 2020 updated by: Aerie Pharmaceuticals

A Multicenter, Open-label Study of Rhopressa® (Netarsudil Ophthalmic Solution) 0.02% for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 4

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

    • California
      • Huntington Beach, California, United States, 92647
        • Atlantis Eyecare
      • Laguna Hills, California, United States, 92653
        • Harvard Eye Associates
      • Petaluma, California, United States, 94954
        • North Bay Eye Associates, Inc
    • Florida
      • Largo, Florida, United States, 33773
        • Shettle Eye Research Inc
      • Sarasota, Florida, United States, 34238
        • Center For Sight
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Coastal Research Associates, LLC
    • Illinois
      • Wheaton, Illinois, United States, 60187
        • Wheaton Eye Clinic, Ltd
    • Kansas
      • Overland Park, Kansas, United States, 66213
        • Stiles Eyecare Excellence and Glaucoma Institute, PA
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Gaddie Eye Centers, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Glaucoma Consultants
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Tekwani Vision Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Mark J. Weiss, M.D., Inc.
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Scott & Christie and Associates, PC
      • Huntingdon Valley, Pennsylvania, United States, 19006
        • Valley Eye Professionals, LLC
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Carolina Cataract & Laser Center
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • VRF Eye Specialty Group
      • Memphis, Tennessee, United States, 38119
        • Total Eye Care, PA
      • Nashville, Tennessee, United States, 37204
        • Advancing Vision Research
    • Texas
      • Austin, Texas, United States, 78731
        • Keystone Research
      • El Paso, Texas, United States, 79902
        • Cataract & Glaucoma Center
      • Houston, Texas, United States, 77025
        • Houston Eye Associates
    • Wisconsin
      • Racine, Wisconsin, United States, 53405
        • The Eye Centers of Racine and Kenosha

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. Male or female subjects (aged 18 or older)
  2. Subjects diagnosed with open-angle glaucoma or ocular hypertension, and determined by the treating physician to require additional intraocular pressure (IOP)-lowering treatment with netarsudil 0.02%.
  3. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing questionnaires and completing laboratory tests

Key Exclusion Criteria:

  1. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation
  2. Women of childbearing potential who are pregnant, nursing, or planning a pregnancy and not using a medically acceptable form of birth control. Male subjects with a female partner of childbearing potential must have had a prior vasectomy or agree to use an effective method of birth control during the treatment period and for 3 months after the subject has completed the study.
  3. Known sensitivity or allergy to the study medication or components
  4. Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results
  5. Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Netarsudil Ophthalmic Solution 0.02%
1 drop in each eye once daily in the evening
Other Names:
  • Rhopressa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure (IOP)
Time Frame: 12 weeks

Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry.

Prostaglandin analog (PGA). Fixed dose combination (FDC).

12 weeks

Collaborators and Investigators

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

Investigators

  • Study Director: David Hollander, MD, MBA, Aerie Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

December 27, 2018

Primary Completion (Actual)

July 26, 2019

Study Completion (Actual)

July 26, 2019

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 17, 2019

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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