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Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle 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
Aerie Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years of age or older (19 years of age or older in Canada)
  2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes
  3. Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits
  4. Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
  5. Able to give informed consent and follow study instructions

Exclusion Criteria:

Ophthalmic:

  1. Clinically significant ocular disease
  2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
  3. Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening
  4. Known hypersensitivity to any component of the formulation or latanoprost
  5. Previous glaucoma surgery or refractive surgery
  6. Ocular trauma within 6 months prior to screening
  7. Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
  8. Recent or current ocular infection or inflammation in either eye
  9. Use of ocular medication in either eye of any kind within 30 days of screening and throughout of the study
  10. Mean central corneal thickness >620µm at screening in either eye

  11. Any abnormality preventing reliable applanation tonometry of either eye

    Systemic:

  12. Clinically significant abnormalities in lab tests at screening
  13. Clinically significant systemic disease
  14. Participation in any investigational study within 60 days prior to screening
  15. Systemic medication that could have had a substantial effect on IOP within 30 days prior to screening, or anticipated to be used during the study
  16. Women of childbearing potential who were 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%

Netarsudil (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)
Mean intraocular pressure(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 Outcome Measures

Full Information

First Posted
February 1, 2016
Last Updated
May 14, 2019
Sponsor
Aerie Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02674854
Brief Title
Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
Official Title
A Prospective, Double-masked, Randomized, Multi-center, Active Controlled, Parallel-group, 3-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
February 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 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 0.02% and latanoprost ophthalmic solution 0.005%

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
750 (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
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 0.02%/0.005%
Intervention Description
1 drop daily 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 daily in the evening (PM) in both eyes (OU)
Intervention Type
Drug
Intervention Name(s)
Latanoprost ophthalmic solution 0.005%
Intervention Description
1 drop daily in the evening (PM) in both eyes (OU)
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
Mean intraocular pressure(IOP) at 08:00, 10:00 and 16:00 hours, at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older (19 years of age or older in Canada) Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better Able to give informed consent and follow study instructions Exclusion Criteria: Ophthalmic: Clinically significant ocular disease Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening Known hypersensitivity to any component of the formulation or latanoprost 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 Use of ocular medication in either eye of any kind within 30 days of screening and throughout of the study Mean central corneal thickness >620µm at screening in either eye Any abnormality preventing reliable applanation tonometry of either eye Systemic: Clinically significant abnormalities in lab tests at screening Clinically significant systemic disease Participation in any investigational study within 60 days prior to screening Systemic medication that could have had a substantial effect on IOP within 30 days prior to screening, or anticipated to be used during the study Women of childbearing potential who were 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:
Citation
Walter TR, Ahmed IK et al. Ophthalmology glaucoma, 2019, pg. 1-10 https://doi.org/10.1016/j.ogla.2019.03.007
Results Reference
result
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
PubMed Identifier
31981106
Citation
Wisely CE, Sheng H, Heah T, Kim T. Effects of Netarsudil and Latanoprost Alone and in Fixed Combination on Corneal Endothelium and Corneal Thickness: Post-Hoc Analysis of MERCURY-2. Adv Ther. 2020 Mar;37(3):1114-1123. doi: 10.1007/s12325-020-01227-y. Epub 2020 Jan 24.
Results Reference
derived

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

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