Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Inclusion Criteria:

1. 19 years of age or greater.

2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).

3. Unmedicated (post-washout) IOP (Intraocular Pressure) >20 mm Hg and < 27 mm Hg in thestudy eye at 2 qualification visits (08:00 hr), 2-7 days apart. At secondqualification visit, IOP > 17 mm Hg and < 27 mm Hg at 10:00 and 16:00 hrs (in the sameeye).

4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS (Early TreatmentDiabetic Retinopathy Study) in each eye (equivalent to 20/200).

5. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria: Ophthalmic:

1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure,or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.

2. Intraocular pressure ≥27 mm Hg (unmedicated) in both eyes (individuals who areexcluded for this criterion are not allowed to attempt requalification), or use ofmore than two ocular hypotensive medications within 30 days of screening. Note: fixeddose combinations count as two medications.

3. Known hypersensitivity to any component of the formulations to be used (benzalkoniumchloride, etc.), to topical anesthetics or β-adrenoceptor antagonists.

4. Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye.

5. Refractive surgery in either eye (e.g., radial keratotomy, PRK (photorefractivekeratectomy), LASIK (laser eye surgery), corneal cross-linking, etc.).

6. Ocular trauma in either eye within the six months prior to screening, or ocularsurgery or non-refractive laser treatment within the three months prior to screening.

7. Recent or current evidence of ocular infection or inflammation in either eye. Currentevidence of clinically significant blepharitis, conjunctivitis, or a history of herpessimplex or zoster keratitis at screening in either eye.

8. Ocular medication in either eye of any kind within 30 days of screening, with theexception of a) ocular hypotensive medications (which must be washed out according tothe provided schedule), b) lid scrubs (which may be used prior to, but not afterscreening) or c) lubricating drops for dry eye (which may be used throughout thestudy).

9. Clinically significant ocular disease in either eye (e.g., corneal edema, uveitis,severe keratoconjunctivitis sicca) which might interfere with the study, includingglaucomatous damage so severe that washout of ocular hypotensive medications for onemonth is not judged safe (e.g., cup-disc ratio > 0.8, severe visual field defect).

10. Central corneal thickness in either eye greater than 600 µm at screening.

11. Any abnormality in either eye preventing reliable applanation tonometry of either eye. Systemic:

12. Clinically relevant abnormalities (as determined by the investigator) in laboratorytests at screening which may impact the study.

13. Known hypersensitivity or contraindication to beta-adrenoceptor antagonists (e.g.,chronic obstructive pulmonary disease or bronchial asthma; abnormally low bloodpressure or heart rate; second or third degree heart block or congestive heartfailure; severe diabetes).

14. Clinically significant systemic disease (e.g., uncontrolled diabetes, myastheniagravis, hepatic, renal, endocrine or cardiovascular disorders) which might interferewith the study.

15. Participation in any investigational study within 30 days prior to screening.

16. Changes of systemic medication that could have an effect on IOP within 30 days priorto screening, or anticipated during the study.

17. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, ornot using a medically acceptable form of birth control. An adult woman is consideredto be of childbearing potential unless she is one year post-menopausal or three monthspost-surgical sterilization. All females of childbearing potential must have anegative urine pregnancy test result at the screening examination and must not intendto become pregnant during the study.