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A Controlled Study of the Aqueous Humor Dynamics of AR-13324 Ophthalmic Solution in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT02406287
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 12, 2015
First Posted Date  ICMJE April 2, 2015
Last Update Posted Date September 13, 2016
Study Start Date  ICMJE April 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2015)
  • Change in aqueous humor flow rate measured by non-contact fluorophotometer [ Time Frame: Day 1 compared to Day 8 ]
    Aqueous humor flow rate measured by non-contact fluorophotometer; change from baseline
  • Change in outflow facility measured non-invasively by tonography [ Time Frame: Day 1 compared to Day 8 ]
    Outflow facility measured non-invasively by tonography; change from baseline
  • Change in episcleral venous pressure measured non-invasively by slit-lamp exam [ Time Frame: Day 1 compared toDay 8 ]
    Episcleral venous pressure measured non-invasively by slit-lamp exam; change from baseline
  • Change in visual acuity measured using eye chart [ Time Frame: Day 1 compared to Day 8 ]
    Visual acuity measured using eye chart; change from baseline
  • Change in biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye [ Time Frame: Day 1 compared to Day 8 ]
    Biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye; change from baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02406287 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2015)
Safety - Number of participants with adverse events [ Time Frame: Day 1 compared to Day 8 ]
Number of participants with adverse events as a measure of safety and tolerability
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Controlled Study of the Aqueous Humor Dynamics of AR-13324 Ophthalmic Solution in Healthy Adult Volunteers
Official Title  ICMJE Not Provided
Brief Summary To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics relative to its placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: Netarsudil (AR-13324) Ophthalmic Solution
    Topical ophthalmic solution
  • Drug: Netarsudil (AR-13324) Ophthalmic Solution Placebo
    Ophthalmic solution once a day
Study Arms  ICMJE
  • Experimental: Active
    Netarsudil (AR-13324) Ophthalmic Solution
    Intervention: Drug: Netarsudil (AR-13324) Ophthalmic Solution
  • Placebo Comparator: Placebo
    Netarsudil (AR-13324) Ophthalmic Solution Placebo
    Intervention: Drug: Netarsudil (AR-13324) Ophthalmic Solution Placebo
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: April 1, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy adult male or female subjects at least 18 years of age.
  2. Local area resident, existing patient or employee of Mayo Clinic.
  3. Medically healthy subjects with clinically insignificant screening results.
  4. Subjects with two normal (non-diseased) eyes.
  5. Intraocular pressure between 14 and 21 mm Hg (inclusive) in each eye at screening.
  6. Best-corrected visual acuity in each eye of +0.4 (20/50) or better.
  7. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

  1. Chronic or acute ophthalmic disease including glaucoma, macular degeneration, uveitis clinically significant cataract.
  2. Known hypersensitivity to any component of the formulation or to topical anesthetics.
  3. Previous intraocular surgery, retina laser procedures or refractive surgery.
  4. Myopia greater than -4.00 D spherical equivalent.
  5. Hyperopia greater than +2.00 D spherical equivalent.
  6. Ocular trauma within the past six months.
  7. Evidence of ocular infection, inflammation, cystoid macular edema, clinically significant blepharitis or conjunctivitis, or a history of herpes simplex keratitis.
  8. Ocular medication of any kind within 30 days of screening.
  9. Any abnormality preventing reliable applanation tonometry of either eye.
  10. Central corneal thickness less than 500 μm or greater than 600 μm.
  11. Cannot demonstrate proper delivery of the eye drop.
  12. Clinically significant systemic disease which might interfere with the study.
  13. Participation in any investigational study within the past 30 days prior to screening.
  14. Use of systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening, or anticipated during the study.
  15. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a physician-supervised form of birth control for at least the last 2 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02406287
Other Study ID Numbers  ICMJE AR-13324-CS102
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: Nancy Ramirez Aerie Pharmaceuticals
PRS Account Aerie Pharmaceuticals
Verification Date September 2016

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