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

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ClinicalTrials.gov Identifier: NCT02558374
Recruitment Status : Completed
First Posted : September 24, 2015
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 708 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 Group, 6-month Study With a 3-month Interim Analysis Assessing the Ocular Hypotensive Efficacy and Safety of AR-13324 Ophthalmic Solution, 0.02% QD Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure
Study Start Date : September 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
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)
Drug: AR-13324 Ophthalmic Solution 0.02%
1 drop once daily (QD), PM, OU
Other Name: Netarsudil

Other: Placebo
1 drop QD, AM, OU

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




Primary Outcome Measures :
  1. IOP (Intraocular Pressure) [ Time Frame: 3 months ]
    The primary efficacy outcome is mean IOP


Secondary Outcome Measures :
  1. Extent of Exposure [ Time Frame: 6 months ]
    Exposure to study medication in days for all treatment groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes
  3. Post-washout intraocular pressure >20mmHg and <30mmHg in 1 or both eyes at 2 qualification visits
  4. Corrected visual acuity equivalent to 20/200
  5. Able to give informed consent and follow study instructions

Exclusion Criteria:

  1. Clinically significant ocular disease
  2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
  3. Unmedicated intraocular pressure ≥30mmHg
  4. Use of more than 2 ocular hypotensive medications within 30 days of screening
  5. Known hypersensitivity to any component of the formulation
  6. Previous glaucoma surgery or refractive surgery
  7. Ocular trauma within 6 months prior to screening
  8. Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
  9. Recent or current ocular infection or inflammation in either eye
  10. Used ocular medication in either eye of any kind within 30 days of screening
  11. Mean central corneal thickness >620µm at screening
  12. Any abnormality preventing reliable applanation tonometry of either eye
  13. Clinically significant abnormalities in lab tests at screening
  14. Known hypersensitivity or contraindication to beta-adrenoceptor antagonists
  15. Clinically significant systemic disease
  16. Participation in any investigational study within 60 days prior to screening
  17. Used any systemic medication that could have a substantial effect in intraocular pressure within 30 days prior to screening
  18. Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

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): NCT02558374


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

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02558374     History of Changes
Other Study ID Numbers: AR-13324-CS304
First Posted: September 24, 2015    Key Record Dates
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
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