- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02207621
Evaluation of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma and Ocular Hypertension
March 9, 2018 updated by: Aerie Pharmaceuticals
A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 12-month Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-13324 Ophthalmic Solution, 0.02% q.d. and b.i.d. Compared to Timolol Maleate Ophthalmic Solution, 0.5% b.i.d. in Patients With Elevated Intraocular Pressure
Evaluation of the ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
756
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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Bedminster, New Jersey, United States, 07921
- Aerie Pharmaceuticals
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Subject inclusion criteria
- 0-2 years of age and 18 years or greater
- Diagnosis of open angle glaucoma or ocular hypertension
- Unmedicated (post-washout) intraocular pressure (IOP) >20 mm Hg and < 27 mm Hg in the study eye at 2 qualification visits
- Corrected visual acuity in each eye equivalent to 20/200
- Able and willing to give signed informed consent (parent or guardian consent for pediatric patient) and follow study instructions
Subject exclusion criteria
Ophthalmic:
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
- Intraocular pressure ≥27 mm Hg (unmedicated) in both eyes or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications.
- Known hypersensitivity to any component of the formulations to be used (benzalkonium chloride, etc.), to topical anesthetics or beta-adrenoceptor antagonists.
- Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye
- Refractive surgery in either eye.
- Ocular trauma in either eye within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening.
- Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or zoster keratitis at screening in either eye.
- Ocular medication in either eye of any kind within 30 days of screening.
- Clinically significant ocular disease in either eye (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe.
- Central corneal thickness in either eye greater than 600 µm at screening.
Any abnormality in either eye preventing reliable applanation tonometry of either eye.
Systemic:
- Clinically relevant abnormalities (as determined by the investigator) in laboratory tests at screening which may impact the study.
- Known hypersensitivity or contraindication to beta-adrenoceptor antagonists (e.g., chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third degree heart block or congestive heart failure; severe diabetes).
- Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
- Participation in any investigational study within 30 days prior to screening.
- Changes of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening, or anticipated during the study.
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study..
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AR-13324 Ophthalmic Solution 0.02% BID
1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
1 drop BID, AM/PM, OU
Other Names:
|
Experimental: AR-13324 Ophthalmic Solution 0.02% & placebo
1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
|
1 drop once daily (QD), PM, OU
Other Names:
1 drop QD, AM, OU
|
Active Comparator: Timolol maleate Ophthalmic Solution 0.5% BID
1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
1 drop BID, AM/PM, OU
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular Pressure (IOP)
Time Frame: 3 months
|
The primary efficacy outcome is mean intraocular pressure (IOP)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extent of Exposure
Time Frame: 12 Months
|
Exposure to study medication in days for all treatment groups
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Theresa Heah, MD, Aerie Pharmaceuticals, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
July 31, 2014
First Submitted That Met QC Criteria
July 31, 2014
First Posted (Estimate)
August 4, 2014
Study Record Updates
Last Update Posted (Actual)
April 6, 2018
Last Update Submitted That Met QC Criteria
March 9, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Timolol
- Ophthalmic Solutions
- Pharmaceutical Solutions
Other Study ID Numbers
- AR-13324-CS302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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