NCT02406287

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

March 12, 2015

Last Update Submit

September 12, 2016

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Safety - Number of participants with adverse events

    Day 1 compared to Day 8

Study Arms (2)

Active

EXPERIMENTAL

Netarsudil (AR-13324) Ophthalmic Solution

Drug: Netarsudil (AR-13324) Ophthalmic Solution

Placebo

PLACEBO COMPARATOR

Netarsudil (AR-13324) Ophthalmic Solution Placebo

Drug: Netarsudil (AR-13324) Ophthalmic Solution Placebo

Interventions

Netarsudil (AR-13324) Ophthalmic SolutionDRUG

Topical ophthalmic solution

Active
Netarsudil (AR-13324) Ophthalmic Solution PlaceboDRUG

Ophthalmic solution once a day

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Chronic or acute ophthalmic disease including glaucoma, macular degeneration, uveitis clinically significant cataract.
  • Known hypersensitivity to any component of the formulation or to topical anesthetics.
  • Previous intraocular surgery, retina laser procedures or refractive surgery.
  • Myopia greater than -4.00 D spherical equivalent.
  • Hyperopia greater than +2.00 D spherical equivalent.
  • Ocular trauma within the past six months.
  • Evidence of ocular infection, inflammation, cystoid macular edema, clinically significant blepharitis or conjunctivitis, or a history of herpes simplex keratitis.
  • Ocular medication of any kind within 30 days of screening.
  • Any abnormality preventing reliable applanation tonometry of either eye.
  • Central corneal thickness less than 500 μm or greater than 600 μm.
  • Cannot demonstrate proper delivery of the eye drop.
  • Clinically significant systemic disease which might interfere with the study.
  • Participation in any investigational study within the past 30 days prior to screening.
  • Use of systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening, or anticipated during the study.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aerie Pharmaceutical

Bedminster, New Jersey, 07921, United States

Location

MeSH Terms

Interventions

netarsudilOphthalmic Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Nancy Ramirez

    Aerie Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2015

First Posted

April 2, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

US(1)