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Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT02246764
Recruitment Status : Completed
First Posted : September 23, 2014
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active comparator Timolol Maleate Ophthalmic Solution, 0.5%.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Glaucoma Drug: AR-13324 Ophthalmic Solution 0.02% Drug: AR-13324 Ophthalmic Solution 0.02% BID Drug: Timolol maleate Ophthalmic Solution 0.5% BID Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 12-month Study Assessing the Safety of AR-13324 Ophthalmic Solution, 0.02% QD & BID Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure
Study Start Date : September 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: AR-13324 Ophthalmic Solution 0.02% & placebo
1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
Drug: AR-13324 Ophthalmic Solution 0.02%
1 drop once daily (QD), PM, OU
Other Name: Netarsudil

Other: Placebo
1 drop QD, AM, OU

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)
Drug: AR-13324 Ophthalmic Solution 0.02% BID
1 drop BID, AM/PM, OU
Other Name: Netarsudil

Active Comparator: Timolol maleate Ophthalmic Solution 0.5% BID
1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
Drug: Timolol maleate Ophthalmic Solution 0.5% BID
1 drop BID, AM/PM, OU




Primary Outcome Measures :
  1. Extent of Exposure [ Time Frame: 12 months ]
    Exposure to study medication in days for all treatment groups



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 19 years of age or greater.
  2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
  3. Unmedicated (post-washout) IOP (Intraocular Pressure) >20 mm Hg and < 27 mm Hg in the study eye at 2 qualification visits (08:00 hr), 2-7 days apart. At second qualification visit, IOP > 17 mm Hg and < 27 mm Hg at 10:00 and 16:00 hrs (in the same eye).
  4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS (Early Treatment Diabetic Retinopathy Study) in each eye (equivalent to 20/200).
  5. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Ophthalmic:

  1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
  2. Intraocular pressure ≥27 mm Hg (unmedicated) in both eyes (individuals who are excluded for this criterion are not allowed to attempt requalification), or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications.
  3. Known hypersensitivity to any component of the formulations to be used (benzalkonium chloride, etc.), to topical anesthetics or β-adrenoceptor antagonists.
  4. Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye.
  5. Refractive surgery in either eye (e.g., radial keratotomy, PRK (photorefractive keratectomy), LASIK (laser eye surgery), corneal cross-linking, etc.).
  6. 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.
  7. 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.
  8. Ocular medication in either eye of any kind within 30 days of screening, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after screening) or c) lubricating drops for dry eye (which may be used throughout the study).
  9. 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 (e.g., cup-disc ratio > 0.8, severe visual field defect).
  10. Central corneal thickness in either eye greater than 600 µm at screening.
  11. Any abnormality in either eye preventing reliable applanation tonometry of either eye.

    Systemic:

  12. Clinically relevant abnormalities (as determined by the investigator) in laboratory tests at screening which may impact the study.
  13. 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).
  14. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
  15. Participation in any investigational study within 30 days prior to screening.
  16. Changes of systemic medication that could have an effect on IOP within 30 days prior to screening, or anticipated during the study.
  17. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246764


Locations
United States, New Jersey
Nancy Ramirez
Bedminster, New Jersey, United States, 07921
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
Study Director: Theresa Heah, MD Aerie Pharmaceuticals

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02246764     History of Changes
Other Study ID Numbers: AR-13324-CS303
First Posted: September 23, 2014    Key Record Dates
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018
Last Verified: January 2018

Keywords provided by Aerie Pharmaceuticals:
Ocular hypertension.
Glaucoma

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors