Back to resultsDouble-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PG324 Ophthalmic Solution 0.02%/0.005%
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
Eligibility Criteria
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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
- Used any systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening
- Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Sites / Locations
- Aerie Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
PG324 Ophthalmic Solution 0.02%/0.005%
AR-13324 Ophthalmic Solution 0.02%
Latanoprost Ophthalmic Solution 0.005%
Arm Description
Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution
Netarsudil 0.02% ophthalmic solution
Latanoprost 0.005% ophthalmic solution
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Extent of Exposure
Exposure to study medication in days for all treatment groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02558400
Brief Title
Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Official Title
A Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Subjects With Elevated Intraocular Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 18, 2015 (Actual)
Primary Completion Date
May 17, 2017 (Actual)
Study Completion Date
June 30, 2017 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
718 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PG324 Ophthalmic Solution 0.02%/0.005%
Arm Type
Experimental
Arm Description
Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution
Arm Title
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 0.02%/0.005%
Intervention Description
1 drop once daily (QD), in the evening (PM) in both eyes (OU)
Intervention Type
Drug
Intervention Name(s)
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Intervention Description
1 drop once daily (QD), in the evening (PM) in both eyes (OU)
Intervention Type
Drug
Intervention Name(s)
Latanoprost Ophthalmic Solution 0.005%
Intervention Description
1 drop once daily (QD), in the evening (PM) in both eyes (OU)
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Extent of Exposure
Description
Exposure to study medication in days for all treatment groups
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 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
Exclusion Criteria:
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
Used any systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening
Women 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
Theresa Heah, MD, MBA
Organizational Affiliation
Aerie Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Aerie Pharmaceuticals
City
Bedminster
State/Province
New Jersey
ZIP/Postal Code
07921
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32166538
Citation
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.
Results Reference
derived
Learn more about this trial
Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
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