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

• ClinicalTrials.gov Identifier: NCT02558400
• Recruitment Status: Completed
• First Posted: September 24, 2015
• Results First Posted: June 4, 2019
• Last Update Posted: June 4, 2019
• Sponsor: Aerie Pharmaceuticals
• Information provided by (Responsible Party): Aerie Pharmaceuticals

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Open-angle Glaucoma; Ocular Hypertension	Drug: PG324 Ophthalmic Solution 0.02%/0.005%; Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%; Drug: Latanoprost Ophthalmic Solution 0.005%	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 718 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-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
• Actual Study Start Date: September 18, 2015
• Actual Primary Completion Date: May 17, 2017
• Actual Study Completion Date: June 30, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: PG324 Ophthalmic Solution 0.02%/0.005%; Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution	Drug: PG324 Ophthalmic Solution 0.02%/0.005%; 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
Active Comparator: AR-13324 Ophthalmic Solution 0.02%; Netarsudil 0.02% ophthalmic solution	Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%; 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
Active Comparator: Latanoprost Ophthalmic Solution 0.005%; Latanoprost 0.005% ophthalmic solution	Drug: Latanoprost Ophthalmic Solution 0.005%; 1 drop once daily (QD), in the evening (PM) in both eyes (OU)

Outcome Measures

Primary Outcome Measures :

1. Intraocular Pressure (IOP) [ Time Frame: Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90) ]
   The primary efficacy variable was mean IOP at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. Secondary analysis were conducted as a part of safety measurements to month 12 on treatment.

Secondary Outcome Measures :

1. Extent of Exposure [ Time Frame: 12 months ]
   Exposure to study medication in days for all treatment groups

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 both eyes at 2 qualification visits. Both eyes had to qualify at all qualification visits
4. Corrected visual acuity equivalent to 20/200 Snellen or better
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

Contacts and Locations

Locations

United States, New Jersey

Aerie Pharmaceuticals

Bedminster, New Jersey, United States, 07921

Sponsors and Collaborators

Aerie Pharmaceuticals

Investigators

• Study Director: Theresa Heah, MD, MBA; Aerie Pharmaceuticals, Inc.

  Study Documents (Full-Text)

Documents provided by Aerie Pharmaceuticals:

Study Protocol  [PDF] June 12, 2017

Statistical Analysis Plan  [PDF] July 20, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Asrani S, Bacharach J, Holland E, McKee H, Sheng H, Lewis RA, Kopczynski CC, Heah T. Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2. Adv Ther. 2020 Apr;37(4):1620-1631. doi: 10.1007/s12325-020-01277-2. Epub 2020 Mar 12.

• Responsible Party: Aerie Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02558400
• Other Study ID Numbers: PG324-CS301
• First Posted: September 24, 2015
• Results First Posted: June 4, 2019
• Last Update Posted: June 4, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions