Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Condition: Primary Open Angle Glaucoma or Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Netarsudil Ophthalmic Solution 0.02%; Placebo Comparator
Intervention description: 1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye; 1 drop daily (QD), in the morning (AM) of Placebo comparator administered to one eye and Netarsudil Ophthalmic Solution 0.02% to the contralateral eye
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Paired comparison study
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Aqueous Humor Dynamics; Trabecular Outflow; Netarsudil

Summary:

      To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02%
      compared to placebo
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be 18 years of age or older

          2. Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both
             eyes

          3. Unmedicated intraocular pressure (IOP) >20 mmHg and < 30 mmHg in both eyes at first
             qualification visit

          4. Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better

          5. Able to give informed consent and follow study instructions

        Exclusion Criteria:

        Ophthalmic:

          1. Clinically significant ocular disease

          2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure
             glaucoma, or narrow angles

          3. Intraocular pressure ≥30 mmHg in either eye

          4. A difference in IOP between eyes >4mmHg at qualification visit

          5. Use of more than two ocular hypotensive medications within 30 days of screening

          6. Known hypersensitivity to any component of the formulation

          7. Previous glaucoma surgery or refractive surgery

          8. Keratorefractive surgery in either eye

          9. Report of ocular injury in either eye within the six months prior to screening or
             ocular or non-refractive surgery within 3 months prior to screening

         10. Recent or current ocular infection or inflammation in either eye

         11. Use of ocular medication in either eye of any kind within 30 days of screening

         12. Mean central corneal thickness greater than 620 μm in either eye

         13. Any abnormality preventing reliable applanation tonometry of either eye

         14. Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP)
             measurement (applicable to 1 site only)

             Systemic:

         15. Clinically significant abnormalities within 6 weeks prior to screening

         16. Clinically significant systemic disease

         17. Participation in any investigational study within 60 days prior to screening

         18. Use of systemic medication that could have an effect on intraocular pressure within 30
             days prior to screening

         19. Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or
             not using a medically acceptable form of birth control