Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
Primary Purpose
Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PG324 Ophthalmic Solution 0.01%
PG324 Ophthalmic Solution 0.02%
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Latanoprost Ophthalmic Solution 0.005%
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Open Angle Glaucoma, Ocular Hypertension, Intraocular Pressure, AR13324, PG324
Eligibility Criteria
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.
Sites / Locations
- Kenneth Sall, M.D.
- United Medical Research Institute
- Aesthetic Eye Care Institute
- Bacharach practice
- Centre For Health Care
- Clayton Eye Center
- Coastal Research Associates, LLC
- Bradley Kwapiszeski, MD
- Taustine Eye Center
- Seidenberg Protzko Eye Associates
- Great Lakes Eye Care
- Comprehensive Eye Care
- Ophthalmic Consultants of Long Island
- Rochester Ophthalmological Group
- Charlotte Eye Ear Nose & Throat Associates, P.A.
- Michael E. Tepedino, M.D.
- The Eye Institute
- Texan Eye
- Glaucoma Associates of Texas - Dallas Office
- Cataract & Glaucoma Center
- Medical Center Ophthalmology Associates
- Stacy R. Smith, M.D.
- Virginia Eye Consultants
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
PG324 Ophthalmic Solution 0.01%
PG324 Ophthalmic Solution 0.02%
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Latanoprost Ophthalmic Solution 0.005%
Arm Description
Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution
Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution
Netarsudil 0.02% ophthalmic solution
Latanoprost 0.005% ophthalmic solution
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP)
The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02057575
Brief Title
Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerie Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
Keywords
Open Angle Glaucoma, Ocular Hypertension, Intraocular Pressure, AR13324, PG324
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
298 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PG324 Ophthalmic Solution 0.01%
Arm Type
Experimental
Arm Description
Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution
Arm Title
PG324 Ophthalmic Solution 0.02%
Arm Type
Experimental
Arm Description
Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution
Arm Title
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Arm Type
Active Comparator
Arm Description
Netarsudil 0.02% ophthalmic solution
Arm Title
Latanoprost Ophthalmic Solution 0.005%
Arm Type
Active Comparator
Arm Description
Latanoprost 0.005% ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
PG324 Ophthalmic Solution 0.01%
Intervention Description
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Intervention Type
Drug
Intervention Name(s)
PG324 Ophthalmic Solution 0.02%
Intervention Description
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Intervention Type
Drug
Intervention Name(s)
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Intervention Description
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Intervention Type
Drug
Intervention Name(s)
Latanoprost Ophthalmic Solution 0.005%
Intervention Description
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.
Time Frame
Study treatment was administered for 28 days, and outcome measures collected on Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Ramirez, M.S.
Organizational Affiliation
Aerie Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Kenneth Sall, M.D.
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
United Medical Research Institute
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Aesthetic Eye Care Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92657
Country
United States
Facility Name
Bacharach practice
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Centre For Health Care
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Clayton Eye Center
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Coastal Research Associates, LLC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Bradley Kwapiszeski, MD
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Taustine Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Seidenberg Protzko Eye Associates
City
Havre De Grace
State/Province
Maryland
ZIP/Postal Code
21078
Country
United States
Facility Name
Great Lakes Eye Care
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Comprehensive Eye Care
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Rochester Ophthalmological Group
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Charlotte Eye Ear Nose & Throat Associates, P.A.
City
Belmont
State/Province
North Carolina
ZIP/Postal Code
28012
Country
United States
Facility Name
Michael E. Tepedino, M.D.
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
The Eye Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Texan Eye
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Glaucoma Associates of Texas - Dallas Office
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Cataract & Glaucoma Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Stacy R. Smith, M.D.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26209587
Citation
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.
Results Reference
derived
Learn more about this trial
Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
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