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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02406287
Other study ID # AR-13324-CS102
Secondary ID
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


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
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