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CompletedNCT02406287Updated Sep 13, 2016

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

A Phase 1 interventional study of Netarsudil (AR-13324) Ophthalmic Solution and Netarsudil (AR-13324) Ophthalmic Solution Placebo in Healthy Subjects, sponsored by Aerie Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-13.

Sponsored by Aerie Pharmaceuticals (part of Alcon) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics relative to its placebo.

02

Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

Aerie Pharmaceuticals is the lead sponsor of 36 studies on the registry; none are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

First submitted before Aerie Pharmaceuticals became part of Alcon.

Browse Aerie Pharmaceuticals studies →All Alcon studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Active

    Netarsudil (AR-13324) Ophthalmic Solution

    Drug: Netarsudil (AR-13324) Ophthalmic Solution

  • Placebo comparator
    Placebo

    Netarsudil (AR-13324) Ophthalmic Solution Placebo

    Drug: Netarsudil (AR-13324) Ophthalmic Solution Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Change in aqueous humor flow rate measured by non-contact fluorophotometer

    Aqueous humor flow rate measured by non-contact fluorophotometer; change from baseline

    Time frame: Day 1 compared to Day 8

  2. Change in outflow facility measured non-invasively by tonography

    Outflow facility measured non-invasively by tonography; change from baseline

    Time frame: Day 1 compared to Day 8

  3. Change in episcleral venous pressure measured non-invasively by slit-lamp exam

    Episcleral venous pressure measured non-invasively by slit-lamp exam; change from baseline

    Time frame: Day 1 compared toDay 8

  4. Change in visual acuity measured using eye chart

    Visual acuity measured using eye chart; change from baseline

    Time frame: Day 1 compared to Day 8

  5. Change in biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye

    Biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye; change from baseline

    Time frame: Day 1 compared to Day 8

Secondary outcomes

  1. Safety - Number of participants with adverse events

    Number of participants with adverse events as a measure of safety and tolerability

    Time frame: Day 1 compared to Day 8

07

Study locations

1 site
  • Aerie Pharmaceutical
    Bedminster, New Jersey 07921, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02406287
Lead sponsor
Aerie Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 2, 2015
Start date
Apr 2015
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Sep 13, 2016

Study contacts

Nancy Ramirez
study director · Aerie Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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