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

Ocular Hypertension Clinical Trial

Official title:

A Prospective, Double-masked, Randomized, Multi-center, Active Controlled, Parallel-group, 3-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution 0.02% and Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674854
• Other study ID #: PG324-CS302
• Status: Completed
• Phase: Phase 3
• Start date: February 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2019
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes

3. Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits

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 or narrow angles

3. Unmedicated intraocular pressure =36mmHg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening

4. Known hypersensitivity to any component of the formulation or latanoprost

5. Previous glaucoma surgery or refractive surgery

6. Ocular trauma within 6 months prior to screening

7. Any 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 of the study

10. Mean central corneal thickness >620µm at screening in either eye

11. Any abnormality preventing reliable applanation tonometry of either eye

Systemic:

12. Clinically significant abnormalities in lab tests at screening

13. Clinically significant systemic disease

14. Participation in any investigational study within 60 days prior to screening

15. Systemic medication that could have had a substantial effect on IOP within 30 days prior to screening, or anticipated to be used during the study

16. Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Drug:
• PG324 Ophthalmic Solution 0.02%/0.005%
1 drop daily in the evening (PM) in both eyes (OU)
• Netarsudil (AR-13324) ophthalmic solution 0.02%
1 drop daily in the evening (PM) in both eyes (OU)
• Latanoprost ophthalmic solution 0.005%
1 drop daily in the evening (PM) in both eyes (OU)

Locations

Country	Name	City	State
United States	Aerie Pharmaceuticals	Bedminster	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Walter TR, Ahmed IK et al. Ophthalmology glaucoma, 2019, pg. 1-10 https://doi.org/10.1016/j.ogla.2019.03.007

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP)	Mean intraocular pressure(IOP) at 08:00, 10:00 and 16:00 hours, at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry.	3 months