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
1 other identifier
interventional
298
1 country
23
Brief Summary
To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2014
Shorter than P25 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 6, 2014
CompletedFirst Posted
Study publicly available on registry
February 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
June 4, 2019
CompletedJune 4, 2019
May 1, 2019
5 months
February 6, 2014
March 27, 2019
May 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
PG324 Ophthalmic Solution 0.01%
EXPERIMENTALNetarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution
PG324 Ophthalmic Solution 0.02%
EXPERIMENTALNetarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
ACTIVE COMPARATORNetarsudil 0.02% ophthalmic solution
Latanoprost Ophthalmic Solution 0.005%
ACTIVE COMPARATORLatanoprost 0.005% ophthalmic solution
Interventions
1 drop in the evening (PM), once daily (QD), both eyes (OU)
1 drop in the evening (PM), once daily (QD), both eyes (OU)
1 drop in the evening (PM), once daily (QD), both eyes (OU)
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Kenneth Sall, M.D.
Artesia, California, 90701, United States
United Medical Research Institute
Inglewood, California, 90301, United States
Aesthetic Eye Care Institute
Newport Beach, California, 92657, United States
Bacharach practice
Petaluma, California, 94954, United States
Centre For Health Care
Poway, California, 92064, United States
Clayton Eye Center
Morrow, Georgia, 30260, United States
Coastal Research Associates, LLC
Roswell, Georgia, 30076, United States
Bradley Kwapiszeski, MD
Shawnee Mission, Kansas, 66204, United States
Taustine Eye Center
Louisville, Kentucky, 40217, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078, United States
Great Lakes Eye Care
Saint Joseph, Michigan, 49085, United States
Comprehensive Eye Care
St Louis, Missouri, 63090, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563, United States
Rochester Ophthalmological Group
Rochester, New York, 14618, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
Belmont, North Carolina, 28012, United States
Michael E. Tepedino, M.D.
High Point, North Carolina, 27262, United States
The Eye Institute
Tulsa, Oklahoma, 74104, United States
Texan Eye
Austin, Texas, 78731, United States
Glaucoma Associates of Texas - Dallas Office
Dallas, Texas, 75231, United States
Cataract & Glaucoma Center
El Paso, Texas, 79902, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Stacy R. Smith, M.D.
Salt Lake City, Utah, 84117, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
Related Publications (1)
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.
PMID: 26209587DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Theresa GH Heah, MD, MBA
- Organization
- Aerie Pharmaceuticals, Inc
Study Officials
- STUDY DIRECTOR
Nancy Ramirez, M.S.
Aerie Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2014
First Posted
February 7, 2014
Study Start
January 1, 2014
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 4, 2019
Results First Posted
June 4, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share