Healthy Subjects
Conditions
Brief summary
To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics relative to its placebo.
Interventions
DRUGNetarsudil (AR-13324) Ophthalmic Solution
Topical ophthalmic solution
DRUGNetarsudil (AR-13324) Ophthalmic Solution Placebo
Ophthalmic solution once a day
Sponsors
Aerie Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed