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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: Netarsudil Ophthalmic Solution 0.02%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Netarsudil Ophthalmic Solution 0.02%<br> | Drug: Netarsudil Ophthalmic Solution 0.02%<br>* 1 drop in each eye once daily in the evening<br>* Other names: Rhopressa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry. Prostaglandin analog (PGA). Fixed dose combination (FDC). | 12 weeks |