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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.
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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 |
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| AR-13324 Ophthalmic Solution 0.02% | Active Comparator | Netarsudil 0.02% ophthalmic solution |
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| Latanoprost Ophthalmic Solution 0.005% | Active Comparator | Latanoprost 0.005% ophthalmic solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG324 Ophthalmic Solution 0.02%/0.005% | Drug | 1 drop once daily (QD), in the evening (PM) in both eyes (OU) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Exposure | Exposure to study medication in days for all treatment groups | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PG324 Ophthalmic Solution 0.02%/0.005% | PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) |
| FG001 | AR-13324 Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), 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 | Jun 12, 2017 | Apr 11, 2019 |
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| Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Drug | 1 drop once daily (QD), in the evening (PM) in both eyes (OU) |
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| Latanoprost Ophthalmic Solution 0.005% | Drug | 1 drop once daily (QD), in the evening (PM) in both eyes (OU) |
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| FG002 | Latanoprost Ophthalmic Solution 0.005% | Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), 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 | PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) |
| BG001 | AR-13324 Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) |
| BG002 | Latanoprost Ophthalmic Solution 0.005% | Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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) | 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. | Intent to Treat (ITT) population | Posted | Mean | Standard Deviation | mmHg | 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) |
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| Secondary | Extent of Exposure | Exposure to study medication in days for all treatment groups | The safety population= all randomized subjects who received at least 1 dose of study medication. The safety population summarized subjects as-treated. 1 Subject was randomized to netarsudil but received latanoprost. Therefore, 1 less subject is in the netarsudil group and 1 additional subject is in the latanoprost group for the safety population. | Posted | Mean | Standard Deviation | days | 12 months |
|
Adverse event data was collected during the course of the study of 12 month treatment and 2 month safety follow up.The safety population summarized subjects as-treated.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product.The safety population summarized subjects as-treated. 1 Subject was randomized to netarsudil but received latanoprost. Therefore, 1 less subject is in the netarsudil group and 1 additional subject is in the latanoprost group for the safety population. (applies to the numbers of subjects for SAEs, all cause mortality and other AEs sections)
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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 | PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) | 0 | 238 | 5 | 238 | 169 | 238 |
| EG001 | AR-13324 Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) | 1 | 243 | 10 | 243 | 160 | 243 |
| EG002 | Latanoprost Ophthalmic Solution 0.005% | Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) | 0 | 237 | 10 | 237 | 74 | 237 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Gastric Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Intraductal Proliferative Breast Lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Ovarian Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Prostate Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Impaired Gastric Emptying | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Coronary Artery Stenosis | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Carotid Artery Stenosis | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Metabolic Encephalopathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Bronchitis Chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Arteriosclerosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Cornea Verticillata | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eye Pruritus | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Conjunctival Haemorrhage | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Punctate Keratitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Instillation Site Pain | General disorders | 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 | Jul 20, 2016 | 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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PG324 vs. latanoprost |
| <0.0001 |
| Superiority |
| Units | Counts |
|---|---|
| Participants |
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