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Double-masked Study of AR-13324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension (Rocket-1)

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ClinicalTrials.gov Identifier: NCT02207491
Recruitment Status : Completed
First Posted : August 4, 2014
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 31, 2014
First Posted Date  ICMJE August 4, 2014
Results First Submitted Date  ICMJE January 17, 2018
Results First Posted Date  ICMJE April 13, 2018
Last Update Posted Date April 13, 2018
Study Start Date  ICMJE July 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2018)
Intraocular Pressure (IOP) [ Time Frame: 3 months ]
The primary efficacy outcome is mean IOP
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2014)
IOP [ Time Frame: 3 months ]
The primary efficacy outcome is mean IOP
Change History Complete list of historical versions of study NCT02207491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2018)
Extent of Exposure [ Time Frame: 3 months ]
Exposure to study medication in days for all treatment groups.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2014)
Ocular safety [ Time Frame: 3 months ]
The primary safety measures will be visual acuity, pupil size, objective biomicroscopic and ophthalmoscopic examination, ocular tolerability, and adverse events.
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 AR-13324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Official Title  ICMJE A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 3-month Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-13324 Ophthalmic Solution, 0.02% Compared to Timolol Maleate Ophthalmic Solution, 0.5% in Patients With Elevated Intraocular Pressure
Brief Summary To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324 Ophthalmic Solution, 0.02% 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
  • Open-angle Glaucoma
Intervention  ICMJE
  • Drug: Timolol maleate Ophthalmic Solution 0.5% BID
    1 drop BID, AM/PM, 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
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 Timolol maleate 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 9, 2015)
411
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2014)
400
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Subject Inclusion criteria:

  1. 0-2 years of age and 18 years or greater.
  2. Diagnosis of open angle glaucoma or ocular hypertension
  3. Unmedicated (post-washout) IOP (Intraocular Pressure) >20 mm Hg and < 27 mm Hg in the study eye at 2 qualification visits.
  4. Corrected visual acuity in each eye equivalent to 20/200.
  5. Able and willing to give signed informed consent (parent or guardian consent for pediatric patient) and follow study instructions.

Subject 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 beta adrenoceptor antagonists.
  4. Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye
  5. Refractive surgery in either eye.
  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.
  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.
  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 intraocular pressure 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 Child, 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 NCT02207491
Other Study ID Numbers  ICMJE AR-13324-CS301
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, 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