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

NCT ID: NCT02406287

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-04-30

Brief Summary

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

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

Netarsudil (AR-13324) Ophthalmic Solution

Group Type: EXPERIMENTAL

Netarsudil (AR-13324) Ophthalmic Solution

Intervention Type: DRUG

Topical ophthalmic solution

Placebo

Netarsudil (AR-13324) Ophthalmic Solution Placebo

Group Type: PLACEBO_COMPARATOR

Netarsudil (AR-13324) Ophthalmic Solution Placebo

Intervention Type: DRUG

Ophthalmic solution once a day

Interventions

Netarsudil (AR-13324) Ophthalmic Solution

Topical ophthalmic solution

Intervention Type: DRUG

Netarsudil (AR-13324) Ophthalmic Solution Placebo

Ophthalmic solution once a day

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aerie Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy Ramirez

Role: STUDY_DIRECTOR

Aerie Pharmaceuticals

Locations

Aerie Pharmaceutical

Bedminster, New Jersey, United States

Countries

United States

Other Identifiers

AR-13324-CS102

Identifier Type: -

Identifier Source: org_study_id