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

NCT02558400 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PG324-CS301
• Study Type: interventional
• Target: 718
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP)

  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.

  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)

Secondary Outcomes (1)

• Extent of Exposure

  12 months

Study Arms (3)

PG324 Ophthalmic Solution 0.02%/0.005%

EXPERIMENTAL

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

Drug: PG324 Ophthalmic Solution 0.02%/0.005%

AR-13324 Ophthalmic Solution 0.02%

ACTIVE COMPARATOR

Netarsudil 0.02% ophthalmic solution

Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%

Latanoprost Ophthalmic Solution 0.005%

ACTIVE COMPARATOR

Latanoprost 0.005% ophthalmic solution

Drug: Latanoprost Ophthalmic Solution 0.005%

Interventions

PG324 Ophthalmic Solution 0.02%/0.005% DRUG

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

PG324 Ophthalmic Solution 0.02%/0.005%

Netarsudil (AR-13324) Ophthalmic Solution 0.02% DRUG

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

AR-13324 Ophthalmic Solution 0.02%

Latanoprost Ophthalmic Solution 0.005% DRUG

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

Latanoprost Ophthalmic Solution 0.005%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Diagnosis of open angle glaucoma or ocular hypertension in both eyes
• Unmedicated intraocular pressure \>20mmHg and \<36mmHg in both eyes at 2 qualification visits. Both eyes had to qualify at all qualification visits
• Corrected visual acuity equivalent to 20/200 Snellen or better
• Able to give informed consent and follow study instructions

You may not qualify if:

• Clinically significant ocular disease
• Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
• Unmedicated Intraocular pressure ≥36mmHg
• Use of more than 2 ocular hypotensive medications within 30 days of screening
• Known hypersensitivity to any component of the formulation
• Previous glaucoma surgery or refractive surgery
• Ocular trauma within 6 months prior to screening
• Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
• Recent or current ocular infection or inflammation in either eye
• Used ocular medication in either eye of any kind within 30 days of screening
• Mean central corneal thickness \>620µm at screening
• Any abnormality preventing reliable applanation tonometry of either eye
• Clinically significant abnormalities in lab tests at screening
• Clinically significant systemic disease
• Participation in any investigational study within 60 days prior to screening

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (1)

Aerie Pharmaceuticals

Bedminster, New Jersey, 07921, United States

Location

Related Publications (1)

• 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.

  PMID: 32166538 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

netarsudil

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Results Point of Contact

• Title: Theresa GH Heah, MD, MBA
• Organization: Aerie Pharmaceuticals, Inc

theah@aeriepharma.com

908-947-3844

Study Officials

• Theresa Heah, MD, MBA

  Aerie Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 24, 2015
• Study Start: September 18, 2015
• Primary Completion: May 17, 2017
• Study Completion: June 30, 2017
• Last Updated: June 4, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)