Clinical trial NCT02406287: A Controlled Study of the Aqueous Humor Dynamics of AR-13324 Ophthalmic Solution in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in aqueous humor flow rate measured by non-contact fluorophotometer
timeFrame: Day 1 compared to Day 8
measure: Change in outflow facility measured non-invasively by tonography
timeFrame: Day 1 compared to Day 8
measure: Change in episcleral venous pressure measured non-invasively by slit-lamp exam
timeFrame: Day 1 compared toDay 8
measure: Change in visual acuity measured using eye chart
timeFrame: Day 1 compared to Day 8
measure: Change in biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye
timeFrame: Day 1 compared to Day 8
Secondary outcomes:
measure: Safety - Number of participants with adverse events
timeFrame: Day 1 compared to Day 8
Other outcomes:
Locations:
city: Bedminster
country: United States
facility: Aerie Pharmaceutical
state: New Jersey
Study officials:
affiliation: Aerie Pharmaceuticals
name: Nancy Ramirez
role: STUDY_DIRECTOR
References: