Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting
NCT ID: NCT03808688
Last Updated: 2020-09-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
261 participants
INTERVENTIONAL
2018-12-27
2019-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Netarsudil Ophthalmic Solution 0.02%
Netarsudil Ophthalmic Solution 0.02%
1 drop in each eye once daily in the evening
Interventions
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Netarsudil Ophthalmic Solution 0.02%
1 drop in each eye once daily in the evening
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Aerie Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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David Hollander, MD, MBA
Role: STUDY_DIRECTOR
Aerie Pharmaceuticals, Inc.
Locations
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Atlantis Eyecare
Huntington Beach, California, United States
Harvard Eye Associates
Laguna Hills, California, United States
North Bay Eye Associates, Inc
Petaluma, California, United States
Shettle Eye Research Inc
Largo, Florida, United States
Center For Sight
Sarasota, Florida, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
Wheaton Eye Clinic, Ltd
Wheaton, Illinois, United States
Stiles Eyecare Excellence and Glaucoma Institute, PA
Overland Park, Kansas, United States
Gaddie Eye Centers, LLC
Louisville, Kentucky, United States
Glaucoma Consultants
Baltimore, Maryland, United States
Tekwani Vision Center
St Louis, Missouri, United States
Mark J. Weiss, M.D., Inc.
Tulsa, Oklahoma, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Valley Eye Professionals, LLC
Huntingdon Valley, Pennsylvania, United States
Carolina Cataract & Laser Center
Ladson, South Carolina, United States
Total Eye Care, PA
Memphis, Tennessee, United States
VRF Eye Specialty Group
Memphis, Tennessee, United States
Advancing Vision Research
Nashville, Tennessee, United States
Keystone Research
Austin, Texas, United States
Cataract & Glaucoma Center
El Paso, Texas, United States
Houston Eye Associates
Houston, Texas, United States
The Eye Centers of Racine and Kenosha
Racine, Wisconsin, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MA-RHO-18-002
Identifier Type: -
Identifier Source: org_study_id
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