Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/23/2017 |
| Start Date: | September 18, 2015 |
| End Date: | June 30, 2017 |
To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to
Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution.
Following completion of the Month 12 study visit procedures, subjects will be offered the
opportunity to participate in a 2-month observational (i.e., non-interventional) trial
extension.
Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution.
Following completion of the Month 12 study visit procedures, subjects will be offered the
opportunity to participate in a 2-month observational (i.e., non-interventional) trial
extension.
Inclusion Criteria:
1. 18 years of age or older
2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes
3. Unmedicated intraocular pressure >20mmHg and <36mmHg in 1 or both eyes at
qualification visits
4. Corrected visual acuity equivalent to 20/200
5. Able to give informed consent and follow study instructions
Exclusion Criteria:
1. Clinically significant ocular disease
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure
or narrow angles
3. Unmedicated Intraocular pressure ≥36mmHg
4. Use of more than 2 ocular hypotensive medications within 30 days of screening
5. Known hypersensitivity to any component of the formulation
6. Previous glaucoma surgery or refractive surgery
7. Ocular trauma within 6 months prior to screening
8. Any ocular surgery or non-refractive laser treatment within 3 months prior to
screening
9. Recent or current ocular infection or inflammation in either eye
10. Used ocular medication in either eye of any kind within 30 days of screening
11. Mean central corneal thickness >620µm at screening
12. Any abnormality preventing reliable applanation tonometry of either eye
13. Clinically significant abnormalities in lab tests at screening
14. Clinically significant systemic disease
15. Participation in any investigational study within 60 days prior to screening
16. Used any systemic medication that could have a substantial effect on intraocular
pressure within 30 days prior to screening
17. Women who are pregnant, nursing, planning a pregnancy or not using a medically
acceptable form of birth control
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