Rocklatan® Evaluation

Study Overview
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Brief Summary
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The objective of this study is to evaluate whether the IOP lowering with Rocklatan® is similar, or demonstrates additional IOP lowering, in subjects on a current regimen of latanoprost alone or latanoprost plus addition of either one or two IOP-lowering agents with another mechanism of action.

Official Title
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A Multicenter, Open-Label Rocklatan® (Netarsudil/Latanoprost Ophthalmic Solution) 0.02%/0.005% Evaluation of IOP Lowering Efficacy and Safety as Replacement of Current Medical Therapy Regimen for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Rocklatan® (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male or female subjects age 18 or older Current diagnosis of open-angle glaucoma or ocular hypertension Subject currently being treated with latanoprost alone or latanoprost plus 1 or 2 additional agents/bottles. Current IOP lowering regimen is stable for at least 30 days prior to Baseline Visit Treated IOP ≥ 20 mmHg measured in the morning (before noon) at the Baseline Visit by Goldmann applanation tonometer Best corrected Snellen visual acuity of 20/100 or better in both eyes Willingness to follow protocol requirements, including signed informed consent and health information release forms, routine follow-up schedule, completing questionnaires Key Exclusion Criteria: Have any active ocular disease other than open-angle glaucoma or ocular hypertension that would interfere with study interpretation Use of fixed dose combination agents as part of the patient's Baseline IOP lowering therapy regimen, if not also on latanoprost Active ocular infection/inflammation or history of uveitis Aphakic or pseudophakic patients with a torn posterior lens capsule, or with known risk factors for macular edema 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 Use of topical, periorbital, intravitreal or systemic steroid within previous 3 months or expected use during the course of the study Prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit. Known sensitivity or allergy to the study medication or components Females who are pregnant, nursing, or planning a pregnancy during the study Positive pregnancy test at Baseline Visit (women of childbearing potential only) Women of childbearing potential who are not using a medically acceptable form of birth control

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
Interventional Model Description: Enrollment will be stratified based on subject's current Baseline Intraocular Pressure (IOP) lowering therapy regimen.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%<br> | Drug: Rocklatan® (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%<br>* Enrolled subjects will be instructed to self-instill 1 drop of Rocklatan® (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% in each eye daily in the evening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | Percentage change of IOP from baseline | Week 12 |