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

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Netarsudil (AR-13324) Ophthalmic Solution; Drug: Netarsudil (AR-13324) Ophthalmic Solution Placebo

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bedminster, New Jersey, United States, 07921
      • Aerie Pharmaceutical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; Netarsudil (AR-13324) Ophthalmic Solution	Drug: Netarsudil (AR-13324) Ophthalmic Solution; Topical ophthalmic solution
Placebo Comparator: Placebo; Netarsudil (AR-13324) Ophthalmic Solution Placebo	Drug: Netarsudil (AR-13324) Ophthalmic Solution Placebo; Ophthalmic solution once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in aqueous humor flow rate measured by non-contact fluorophotometer	Aqueous humor flow rate measured by non-contact fluorophotometer; change from baseline	Day 1 compared to Day 8
Change in outflow facility measured non-invasively by tonography	Outflow facility measured non-invasively by tonography; change from baseline	Day 1 compared to Day 8
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	Day 1 compared toDay 8
Change in visual acuity measured using eye chart	Visual acuity measured using eye chart; change from baseline	Day 1 compared to Day 8
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	Day 1 compared to Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Number of participants with adverse events	Number of participants with adverse events as a measure of safety and tolerability	Day 1 compared to Day 8

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals
• Investigators: Study Director: Nancy Ramirez, Aerie Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: AR-13324-CS102