Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting
- Conditions
- Glaucoma, Open-AngleOcular Hypertension
- Interventions
- Registration Number
- NCT03808688
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
- Male or female subjects (aged 18 or older)
- 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%.
- Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing questionnaires and completing laboratory tests
Key
- Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation
- 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.
- Known sensitivity or allergy to the study medication or components
- 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
- Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Netarsudil Ophthalmic Solution 0.02% Netarsudil Ophthalmic Solution 0.02% -
- Primary Outcome Measures
Name Time Method Intraocular Pressure (IOP) 12 weeks Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry.
Prostaglandin analog (PGA). Fixed dose combination (FDC).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Keystone Research
🇺🇸Austin, Texas, United States
The Eye Centers of Racine and Kenosha
🇺🇸Racine, Wisconsin, United States
Coastal Research Associates, LLC
🇺🇸Roswell, Georgia, United States
Carolina Cataract & Laser Center
🇺🇸Ladson, South Carolina, United States
Wheaton Eye Clinic, Ltd
🇺🇸Wheaton, Illinois, United States
Total Eye Care, PA
🇺🇸Memphis, Tennessee, United States
Harvard Eye Associates
🇺🇸Laguna Hills, California, United States
Valley Eye Professionals, LLC
🇺🇸Huntingdon Valley, Pennsylvania, United States
Atlantis Eyecare
🇺🇸Huntington Beach, California, United States
Glaucoma Consultants
🇺🇸Baltimore, Maryland, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Stiles Eyecare Excellence and Glaucoma Institute, PA
🇺🇸Overland Park, Kansas, United States
Shettle Eye Research Inc
🇺🇸Largo, Florida, United States
North Bay Eye Associates, Inc
🇺🇸Petaluma, California, United States
Center For Sight
🇺🇸Sarasota, Florida, United States
VRF Eye Specialty Group
🇺🇸Memphis, Tennessee, United States
Advancing Vision Research
🇺🇸Nashville, Tennessee, United States
Cataract & Glaucoma Center
🇺🇸El Paso, Texas, United States
Gaddie Eye Centers, LLC
🇺🇸Louisville, Kentucky, United States
Scott & Christie and Associates, PC
🇺🇸Cranberry Township, Pennsylvania, United States
Tekwani Vision Center
🇺🇸Saint Louis, Missouri, United States
Mark J. Weiss, M.D., Inc.
🇺🇸Tulsa, Oklahoma, United States