Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension



Status:Not yet recruiting
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:February 2016
Contact:Nancy Ramirez
Email:nramirez@aeriepharma.com
Phone:1-888-594-5111

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To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to
netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%


Inclusion Criteria:

1. 18 years of age or older (19 years of age or older in Canada)

2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes

3. Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 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 30 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
We found this trial at
1
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Bedminster, New Jersey 07921
Phone: 888-594-5111
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