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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 16, 2015
First Posted Date  ICMJE September 24, 2015
Results First Submitted Date  ICMJE January 17, 2018
Results First Posted Date  ICMJE April 6, 2018
Last Update Posted Date April 6, 2018
Study Start Date  ICMJE September 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
IOP (Intraocular Pressure) [ Time Frame: 3 months ]
The primary efficacy outcome is mean IOP
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
Mean intraocular pressure [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT02558374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
Extent of Exposure [ Time Frame: 6 months ]
Exposure to study medication in days for all treatment groups
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]
  • Changes in visual acuity from baseline [ Time Frame: 6 months ]
  • Changes in visual field test from baseline [ Time Frame: 6 months ]
  • Changes in pupil size from baseline [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Official Title  ICMJE 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
Brief Summary To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Open-angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: AR-13324 Ophthalmic Solution 0.02%
    1 drop once daily (QD), PM, OU
    Other Name: Netarsudil
  • Drug: Timolol Maleate Ophthalmic Solution 0.5% BID
    1 drop BID, AM/PM, OU
  • Other: Placebo
    1 drop QD, AM, OU
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: AR-13324 Ophthalmic Solution 0.02%
    • Other: Placebo
  • Active Comparator: Timolol Maleate Ophthalmic Solution 0.5% BID
    1 drop twice daily (BID) in the morning (AM) & evening (PM) in both eyes (OU)
    Intervention: Drug: Timolol Maleate Ophthalmic Solution 0.5% BID
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2017)
708
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2015)
700
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02558374
Other Study ID Numbers  ICMJE AR-13324-CS304
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aerie Pharmaceuticals
Study Sponsor  ICMJE Aerie Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Theresa Heah, MD Aerie Pharmaceuticals, Inc
PRS Account Aerie Pharmaceuticals
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP