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Trial record 15 of 19 for:    netarsudil

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03808688
Recruitment Status : Active, not recruiting
First Posted : January 17, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: Netarsudil Ophthalmic Solution 0.02% Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Netarsudil Ophthalmic Solution 0.02% Drug: Netarsudil Ophthalmic Solution 0.02%
1 drop in each eye once daily in the evening
Other Name: Rhopressa




Primary Outcome Measures :
  1. Intraocular pressure (IOP) [ Time Frame: 12 weeks ]
    Percent Change from Baseline IOP at Week 12 will be measured in the study eye using a Goldmann applanation tonometer.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808688


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

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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03808688     History of Changes
Other Study ID Numbers: MA-RHO-18-002
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions