Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting
Primary Purpose
Glaucoma, Open-Angle, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Netarsudil Ophthalmic Solution 0.02%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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
Sites / Locations
- Atlantis Eyecare
- Harvard Eye Associates
- North Bay Eye Associates, Inc
- Shettle Eye Research Inc
- Center For Sight
- Coastal Research Associates, LLC
- Wheaton Eye Clinic, Ltd
- Stiles Eyecare Excellence and Glaucoma Institute, PA
- Gaddie Eye Centers, LLC
- Glaucoma Consultants
- Tekwani Vision Center
- Mark J. Weiss, M.D., Inc.
- Scott & Christie and Associates, PC
- Valley Eye Professionals, LLC
- Carolina Cataract & Laser Center
- Total Eye Care, PA
- VRF Eye Specialty Group
- Advancing Vision Research
- Keystone Research
- Cataract & Glaucoma Center
- Houston Eye Associates
- The Eye Centers of Racine and Kenosha
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Netarsudil Ophthalmic Solution 0.02%
Arm Description
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP)
Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry.
Prostaglandin analog (PGA). Fixed dose combination (FDC).
Secondary Outcome Measures
Full Information
NCT ID
NCT03808688
First Posted
January 10, 2019
Last Updated
September 8, 2020
Sponsor
Aerie Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03808688
Brief Title
Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 27, 2018 (Actual)
Primary Completion Date
July 26, 2019 (Actual)
Study Completion Date
July 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerie Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Netarsudil Ophthalmic Solution 0.02%
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Netarsudil Ophthalmic Solution 0.02%
Other Intervention Name(s)
Rhopressa
Intervention Description
1 drop in each eye once daily in the evening
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry.
Prostaglandin analog (PGA). Fixed dose combination (FDC).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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 Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hollander, MD, MBA
Organizational Affiliation
Aerie Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Atlantis Eyecare
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
North Bay Eye Associates, Inc
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Shettle Eye Research Inc
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Center For Sight
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34238
Country
United States
Facility Name
Coastal Research Associates, LLC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Wheaton Eye Clinic, Ltd
City
Wheaton
State/Province
Illinois
ZIP/Postal Code
60187
Country
United States
Facility Name
Stiles Eyecare Excellence and Glaucoma Institute, PA
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Gaddie Eye Centers, LLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Glaucoma Consultants
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Mark J. Weiss, M.D., Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Valley Eye Professionals, LLC
City
Huntingdon Valley
State/Province
Pennsylvania
ZIP/Postal Code
19006
Country
United States
Facility Name
Carolina Cataract & Laser Center
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
VRF Eye Specialty Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Advancing Vision Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Keystone Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Cataract & Glaucoma Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
The Eye Centers of Racine and Kenosha
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33733980
Citation
Zaman F, Gieser SC, Schwartz GF, Swan C, Williams JM. A multicenter, open-label study of netarsudil for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension in a real-world setting. Curr Med Res Opin. 2021 Jun;37(6):1011-1020. doi: 10.1080/03007995.2021.1901222. Epub 2021 Mar 27.
Results Reference
derived
Learn more about this trial
Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting
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