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

Healthy Subjects Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406287
• Other study ID #: AR-13324-CS102
• Status: Completed
• Phase: Phase 1
• First received: March 12, 2015
• Last updated: September 12, 2016
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Netarsudil (AR-13324) Ophthalmic Solution
Topical ophthalmic solution
• Netarsudil (AR-13324) Ophthalmic Solution Placebo
Ophthalmic solution once a day

Locations

Country	Name	City	State
United States	Aerie Pharmaceutical	Bedminster	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Primary	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	No
Primary	Change in visual acuity measured using eye chart	Visual acuity measured using eye chart; change from baseline	Day 1 compared to Day 8	No
Primary	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	No
Secondary	Safety - Number of participants with adverse events	Number of participants with adverse events as a measure of safety and tolerability	Day 1 compared to Day 8	Yes