Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure

To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: PG324 Ophthalmic Solution 0.01%; Drug: PG324 Ophthalmic Solution 0.02%; Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%; Drug: Latanoprost Ophthalmic Solution 0.005%

• Study Type: Interventional
• Enrollment (Actual): 298
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Kenneth Sall, M.D.
    • Inglewood, California, United States, 90301
      • United Medical Research Institute
    • Newport Beach, California, United States, 92657
      • Aesthetic Eye Care Institute
    • Petaluma, California, United States, 94954
      • Bacharach practice
    • Poway, California, United States, 92064
      • Centre For Health Care
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Center
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates, LLC
  • Kansas
    • Shawnee Mission, Kansas, United States, 66204
      • Bradley Kwapiszeski, MD
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Taustine Eye Center
  • Maryland
    • Havre De Grace, Maryland, United States, 21078
      • Seidenberg Protzko Eye Associates
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Great Lakes Eye Care
  • Missouri
    • Saint Louis, Missouri, United States, 63090
      • Comprehensive Eye Care
  • New York
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group
  • North Carolina
    • Belmont, North Carolina, United States, 28012
      • Charlotte Eye Ear Nose & Throat Associates, P.A.
    • High Point, North Carolina, United States, 27262
      • Michael E. Tepedino, M.D.
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • The Eye Institute
  • Texas
    • Austin, Texas, United States, 78731
      • Texan Eye
    • Dallas, Texas, United States, 75231
      • Glaucoma Associates of Texas - Dallas Office
    • El Paso, Texas, United States, 79902
      • Cataract & Glaucoma Center
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Stacy R. Smith, M.D.
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or greater.
• Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
• Corrected visual acuity in each eye equivalent to 20/200 or better
• Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Ophthalmic:

• Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
• Intraocular pressure >36 mmHg
• Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics.
• Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s)
• Refractive surgery in study eye(s)
• Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
• Evidence of ocular infection and inflammation
• Clinically significant ocular disease, which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
• Central corneal thickness greater then 600 μm
• Any abnormality preventing reliable applanation tonometry of either eye

Systemic:

• Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
• Clinically significant systemic disease
• Participation in any investigational study within 30 days prior to screening
• Changes in systemic medication
• Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PG324 Ophthalmic Solution 0.01%; Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution	Drug: PG324 Ophthalmic Solution 0.01%; 1 drop in the evening (PM), once daily (QD), both eyes (OU)
Experimental: PG324 Ophthalmic Solution 0.02%; Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution	Drug: PG324 Ophthalmic Solution 0.02%; 1 drop in the evening (PM), once daily (QD), both eyes (OU)
Active Comparator: Netarsudil (AR-13324) Ophthalmic Solution 0.02%; Netarsudil 0.02% ophthalmic solution	Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%; 1 drop in the evening (PM), once daily (QD), both eyes (OU)
Active Comparator: Latanoprost Ophthalmic Solution 0.005%; Latanoprost 0.005% ophthalmic solution	Drug: Latanoprost Ophthalmic Solution 0.005%; 1 drop in the evening (PM), once daily (QD), both eyes (OU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure (IOP)	The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.	Study treatment was administered for 28 days, and outcome measures collected on Day 29

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals
• Investigators: Study Director: Nancy Ramirez, M.S., Aerie Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• Lewis RA, Levy B, Ramirez N, Kopczynski CC, Usner DW, Novack GD; PG324-CS201 Study Group. Fixed-dose combination of AR-13324 and latanoprost: a double-masked, 28-day, randomised, controlled study in patients with open-angle glaucoma or ocular hypertension. Br J Ophthalmol. 2016 Mar;100(3):339-44. doi: 10.1136/bjophthalmol-2015-306778. Epub 2015 Jul 24. Erratum In: Br J Ophthalmol. 2016 Jul;100(7):1016.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: February 6, 2014
• First Posted (Estimate): February 7, 2014

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Intraocular Pressure; Ocular Hypertension; Open Angle Glaucoma; AR13324; PG324
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions; Latanoprost
• Other Study ID Numbers: PG324-CS201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No