Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension
Condition: Primary Open Angle Glaucoma or Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: AR-13324 Ophthalmic Solution 0.02%; AR-13324 Ophthalmic Solution 0.04%; AR-13324 Ophthalmic Solution Placebo
Intervention description: Administered to each eye, once daily (QD) in the evening (PM) for 28 days; Administered to each eye, once daily (QD) in the evening (PM) for 28 days; Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative
      to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular
      hypertension in US.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be 18 years or older

          2. Be of Japanese ethnicity within the 2nd generation defined as (a) 1st generation born
             in Japan, immigrated to US and (b) 2nd generation - parents are 1st generation and
             patient was born in US as an American citizen

          3. Diagnosis of open-angle glaucoma or ocular hypertension in both eyes

          4. Medicated intraocular pressure >/= 15 mmHg and < 30 mmHg in both eyes at screening

          5. OAG eyes - unmedicated IOP >/= 15 mmHg and < 35 mmHg at 2 qualification visits at
             08:00, 10:00 and 16:00

          6. OHT eyes - unmedicated IOP >/= 22 mmHg and < 35mmHg at 08:00, 10:00 and 16:00

          7. Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye

          8. Able to give signed informed consent and follow instructions

        Exclusion Criteria:

          1. Clinically significant ocular disease

          2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure
             glaucoma or narrow angles

          3. Intraocular pressure >/=35 mmHg in either eye

          4. Ocular hyperemia score of moderate (+2) at qualification visit #2

          5. Previous glaucoma intraocular surgery

          6. Refractive surgery in either eye

          7. Ocular injury within 6 months prior to screening or ocular surgery or non-refractive
             laser treatment within 3 months prior to screening

          8. Recent or current ocular infection or inflammation in either eye

          9. Use of ocular medication in either eye of any kind within 30 days of screening and
             throughout the study

         10. Mean central corneal thickness > 620 µm in either eye

         11. Any abnormality preventing reliable applanation tonometry of either eye

         12. Known hypersensitivity to benzalkonium chloride or excipients of netarsudil ophthalmic
             solution

         13. Clinically significant abnormalities in screening lab tests

         14. Clinically significant systemic disease that might interfere with the study

         15. Participated in any investigational study within 30 days prior to screening

         16. Systemic medication that could have a substantial effect on IOP within 30 days prior
             to screening or anticipated during the study

         17. Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or
             not using a medically acceptable form of birth control