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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Subjects

In brief

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

Key facts

Study ID

NCT02406287

Run by

Aerie Pharmaceuticals

People needed

10

Starts

2015-04-01

Expected to finish

2016-04-01

Last updated by the study team

2016-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Aerie Pharmaceutical — Bedminster, New Jersey, United States

Full record on ClinicalTrials.gov

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