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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

Tracking Information
First Submitted Date  ICMJE September 16, 2014
First Posted Date  ICMJE September 23, 2014
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 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
Extent of Exposure [ Time Frame: 12 months ]
Exposure to study medication in days for all treatment groups
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2014)
  • Adverse events [ Time Frame: 12 months ]
    Ocular and systemic safety
  • Visual acuity [ Time Frame: 12 months ]
    Measured using ETDRS eye charts
  • Evaluation of anterior and posterior segment [ Time Frame: 12 months ]
    Ophthalmologist evaluation using biomicroscope and ophthalmoscope using scoring system
Change History Complete list of historical versions of study NCT02246764 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Official Title  ICMJE 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
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%.
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
  • Ocular Hypertension
  • Glaucoma
Intervention  ICMJE
  • Drug: AR-13324 Ophthalmic Solution 0.02%
    1 drop once daily (QD), PM, OU
    Other Name: Netarsudil
  • Drug: AR-13324 Ophthalmic Solution 0.02% BID
    1 drop BID, AM/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) and 1 drop placebo in the morning (AM) in both eyes (OU)
    Interventions:
    • Drug: AR-13324 Ophthalmic Solution 0.02%
    • Other: Placebo
  • 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)
    Intervention: Drug: AR-13324 Ophthalmic Solution 0.02% BID
  • 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)
    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)
93
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2014)
240
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. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 99 Years   (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 NCT02246764
Other Study ID Numbers  ICMJE AR-13324-CS303
Has Data Monitoring Committee No
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
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