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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%
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PG324 Ophthalmic Solution 0.02%/0.005% | Experimental | Fixed combination of netarsudil 0.02%, latanoprost 0.005 % ophthalmic solution |
|
| Netarsudil (AR-13324) ophthalmic solution 0.02% | Active Comparator | Netarsudil 0.02% ophthalmic solution |
|
| Latanoprost ophthalmic solution 0.005% | Active Comparator | Latanoprost 0.005 % ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG324 Ophthalmic Solution 0.02%/0.005% | Drug | 1 drop daily in the evening (PM) in both eyes (OU) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Heah, MD, MBA | Aerie Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aerie Pharmaceuticals | Bedminster | New Jersey | 07921 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Walter TR, Ahmed IK et al. Ophthalmology glaucoma, 2019, pg. 1-10 https://doi.org/10.1016/j.ogla.2019.03.007 | ||
| 32166538 | Derived | 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. | |
| 31981106 |
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| ID | Title | Description |
|---|---|---|
| FG000 | PG324 Ophthalmic Solution 0.02%/0.005% | 1 drop daily in the evening (PM) in both eyes (OU) |
| FG001 | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | 1 drop daily in the evening (PM) in both eyes (OU) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2016 | Apr 11, 2019 |
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| Netarsudil (AR-13324) ophthalmic solution 0.02% | Drug | 1 drop daily in the evening (PM) in both eyes (OU) |
|
| Latanoprost ophthalmic solution 0.005% | Drug | 1 drop daily in the evening (PM) in both eyes (OU) |
|
| Derived |
| 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. |
| FG002 | Latanoprost Ophthalmic Solution 0.005% | 1 drop daily in the evening (PM) in both eyes (OU) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PG324 Ophthalmic Solution | 1 drop daily in the evening (PM) in both eyes (OU) |
| BG001 | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | 1 drop daily in the evening (PM) in both eyes (OU) |
| BG002 | Latanoprost Ophthalmic Solution 0.005% | 1 drop daily in the evening (PM) in both eyes (OU) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat (ITT) population with Monte Carlo Markov Chain (MCMC) imputation | Posted | Mean | Standard Deviation | mmHg | 3 months |
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Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PG324 Ophthalmic Solution | 1 drop daily in the evening (PM) in both eyes (OU) | 0 | 244 | 2 | 244 | 157 | 244 |
| EG001 | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | 1 drop daily in the evening (PM) in both eyes (OU) | 1 | 255 | 6 | 255 | 143 | 255 |
| EG002 | Latanoprost Ophthalmic Solution 0.005% | 1 drop daily in the evening (PM) in both eyes (OU) | 0 | 251 | 5 | 251 | 78 | 251 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Retinal Detachment | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vertebral Artery Stenosis | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Mental Status Changes | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cornea Verticillata | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Conjunctival Haemorrhage | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Corneal Disorder | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Instillation Site Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Instillation Site Discomfort | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vital Dye Staining Cornea Present | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theresa GH Heah, MD, MBA | Aerie Pharmaceuticals, Inc | 908-947-3844 | theah@aeriepharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2017 | Apr 11, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000603944 | netarsudil |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Day 1, 1600 hours |
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| Day 15, 0800 hours |
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| Day 15, 1000 hours |
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| Day 15, 1600 hours |
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| Day 43, 0800 hours |
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| Day 43, 1000 hours |
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| Day 43, 1600 hours |
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| Day 90, 0800 hours |
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| Day 90, 1000 hours |
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| Day 90, 1600 hours |
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| <0.0001 |
| Superiority |