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To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR-13324 Ophthalmic Solution 0.02% & placebo | Experimental | 1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU) |
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| Timolol Maleate Ophthalmic Solution 0.5% BID | Active Comparator | 1 drop twice daily (BID) in the morning (AM) & evening (PM) in both eyes (OU) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR-13324 Ophthalmic Solution 0.02% | Drug | 1 drop once daily (QD), PM, OU |
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| Measure | Description | Time Frame |
|---|---|---|
| IOP (Intraocular Pressure) | The primary efficacy outcome is mean IOP | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Exposure | Exposure to study medication in days for all treatment groups | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Heah, MD | Aerie Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aerie Pharmaceuticals | Bedminster | New Jersey | 07921 | United States |
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Participants were recruited at 53 sites starting in September 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | AR-13324 Ophthalmic Solution 0.02% & Placebo | 1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU) |
| FG001 | Timolol Maleate Ophthalmic Solution 0.5% BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Timolol Maleate Ophthalmic Solution 0.5% BID | Drug | 1 drop BID, AM/PM, OU |
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| Placebo | Other | 1 drop QD, AM, OU |
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1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AR-13324 Ophthalmic Solution 0.02% & Placebo | 1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU) |
| BG001 | Timolol Maleate Ophthalmic Solution 0.5% BID | 1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) |
| BG002 | 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, 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 | IOP (Intraocular Pressure) | The primary efficacy outcome is mean IOP | Per-Protocol Population | Posted | Mean | Standard Deviation | mmHg | 3 months |
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| Secondary | Extent of Exposure | Exposure to study medication in days for all treatment groups | Safety Population | Posted | Mean | Standard Deviation | days | 6 months |
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6 months
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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 | AR-13324 Ophthalmic Solution 0.02% & Placebo | 1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU) | 1 | 351 | 8 | 351 | 245 | 351 |
| EG001 | Timolol Maleate Ophthalmic Solution 0.5% BID | 1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) | 0 | 357 | 10 | 357 | 139 | 357 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Chronic Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Papillary Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Cardiomegaly | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Facial Paralysis | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Gastric Volvulus | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Hiatus Hernia | Gastrointestinal 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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| Radius Fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Mental Status Changes | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
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| Bladder Prolapse | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
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| Cervical Dysplasia | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
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| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | 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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| Conjunctival Haemorrhage | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Erythema of Eyelid | 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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| Instillation Site Erythema | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Vital Dye Staining Cornea Present | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Ramirez-Davis, Director of Clinical Project Management | Aerie Pharmaceuticals, Inc. | 908-947-3543 | nramirez@aeriepharma.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000603944 | netarsudil |
| C494814 | BID protein, human |
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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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