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

NCT ID: NCT02558400

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 718 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-18
• Study Completion Date: 2017-06-30

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.

Conditions

Open-angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PG324 Ophthalmic Solution 0.02%/0.005%

Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution

Group Type: EXPERIMENTAL

PG324 Ophthalmic Solution 0.02%/0.005%

Intervention Type: DRUG

1 drop once daily (QD), in the evening (PM) in both eyes (OU)

AR-13324 Ophthalmic Solution 0.02%

Netarsudil 0.02% ophthalmic solution

Group Type: ACTIVE_COMPARATOR

Netarsudil (AR-13324) Ophthalmic Solution 0.02%

Intervention Type: DRUG

1 drop once daily (QD), in the evening (PM) in both eyes (OU)

Latanoprost Ophthalmic Solution 0.005%

Latanoprost 0.005% ophthalmic solution

Group Type: ACTIVE_COMPARATOR

Latanoprost Ophthalmic Solution 0.005%

Intervention Type: DRUG

1 drop once daily (QD), in the evening (PM) in both eyes (OU)

Interventions

PG324 Ophthalmic Solution 0.02%/0.005%

1 drop once daily (QD), in the evening (PM) in both eyes (OU)

Intervention Type: DRUG

Netarsudil (AR-13324) Ophthalmic Solution 0.02%

1 drop once daily (QD), in the evening (PM) in both eyes (OU)

Intervention Type: DRUG

Latanoprost Ophthalmic Solution 0.005%

1 drop once daily (QD), in the evening (PM) in both eyes (OU)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerie Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theresa Heah, MD, MBA

Role: STUDY_DIRECTOR

Aerie Pharmaceuticals, Inc.

Locations

Aerie Pharmaceuticals

Bedminster, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32166538 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PG324-CS301

Identifier Type: -

Identifier Source: org_study_id