A Controlled Study of the Aqueous Humor Dynamics of AR-13324 Ophthalmic Solution in Healthy Adult Volunteers
Phase 1
Completed
- Conditions
- Healthy Subjects
- Interventions
- Registration Number
- NCT02406287
- Lead Sponsor
- Aerie Pharmaceuticals
- Brief Summary
To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics relative to its placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Netarsudil (AR-13324) Ophthalmic Solution Netarsudil (AR-13324) Ophthalmic Solution Placebo Netarsudil (AR-13324) Ophthalmic Solution Placebo Netarsudil (AR-13324) Ophthalmic Solution Placebo
- Primary Outcome Measures
Name Time Method Change in aqueous humor flow rate measured by non-contact fluorophotometer 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method Safety - Number of participants with adverse events Day 1 compared to Day 8 Number of participants with adverse events as a measure of safety and tolerability
Trial Locations
- Locations (1)
Aerie Pharmaceutical
🇺🇸Bedminster, New Jersey, United States