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

Phase 3

Completed

• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Interventions: Drug: Netarsudil (AR-13324) ophthalmic solution 0.02%; Drug: PG324 Ophthalmic Solution 0.02%/0.005%; Drug: Latanoprost ophthalmic solution 0.005%

• Registration Number: NCT02674854
• Lead Sponsor: Aerie Pharmaceuticals

Brief 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%

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-05
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Disposition First Submitted: 2018-04-12
• Disposition First Submitted QC: 2018-04-12
• Disposition First Posted: 2018-04-17
• Results First Submitted: 2019-04-11
• Results First Submitted QC: 2019-04-11
• Status Verified: 2019-05
• Results First Posted: 2019-05-01
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Netarsudil (AR-13324) ophthalmic solution 0.02%	Netarsudil (AR-13324) ophthalmic solution 0.02%	Netarsudil 0.02% ophthalmic solution
PG324 Ophthalmic Solution 0.02%/0.005%	PG324 Ophthalmic Solution 0.02%/0.005%	Fixed combination of netarsudil 0.02%, latanoprost 0.005 % ophthalmic solution
Latanoprost ophthalmic solution 0.005%	Latanoprost ophthalmic solution 0.005%	Latanoprost 0.005 % ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	3 months	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.

Trial Locations

Locations (1)

Aerie Pharmaceuticals; 🇺🇸 Bedminster, New Jersey, United States