Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

• Status: Completed
• Trial end date: 2018-04-19
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aerie Pharmaceuticals
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

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