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In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye), once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR-13324 Ophthalmic Solution 0.01% | Experimental | 1 drop to study eye once daily |
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| AR-13324 Ophthalmic Solution 0.02% | Experimental | 1 drop to study eye once daily |
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| AR-13324 Ophthalmic Solution 0.04% | Experimental | 1 drop to study eye once daily |
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| AR-13324 Ophthalmic Solution Vehicle | Placebo Comparator | 1 drop to study eye once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR-13324 Ophthalmic Solution 0.01% | Drug | Administered to study eye, once daily (QD) in the morning (AM) for 7 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | The primary efficacy outcome was the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8. Instillation of study treatment commenced on Day 2 following measurement of IOP. IOP was measured at 0800, 1000, 1200 and 1600 hours on days 2 and 8. IOP was also measured at 0800 hours on Day 4. | Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8. |
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Inclusion Criteria:
Exclusion Criteria:
Ophthalmic: Either eye
Intraocular pressure > 36 mm Hg
Known hypersensitivity to any component of the formulation or to topical anesthetics, (benzalkonium chloride, etc.)
Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or history of herpes simplex keratitis.
Contact lens wear within 30 minutes of instillation of study medication.
Ocular medication of any kind within 30 days of Visit 2, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 2) or c) lubricating drops for dry eye (which may be used throughout the study),
Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe (e.g., advanced glaucomatous optic nerve head or visual field loss).
Any abnormality preventing reliable applanation tonometry in either eye. Study eye:
Glaucoma: pseudoexfoliation or pigment dispersion component, history of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy. Note: Previous laser peripheral iridotomy is NOT acceptable.
Previous glaucoma intraocular surgery or laser procedures such as argon laser trabeculoplasty (ALT), selective laser trabeculoplasty (SLT) or micropulse laser trabeculoplasty ( MLT), as well as refractive procedures such as radio keratotomy (RK), laser eye surgery (LASIK), photorefractive keratectomy (PRK), or collagen cross linking.
Central corneal thickness greater than 600 μm.
General/Systemic:
Clinically significant abnormalities in laboratory tests at screening, recognizing that subjects are not fasting at the time of drawing blood.
Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
Participation in any investigational study within the past 30 days.
Changes of systemic medication during the study that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
Due to status of preclinical safety program, women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study.
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Heah, MD | Aerie Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aesthetic Eye Care Institute | Newport Beach | California | 92657 | United States | ||
| Robert Noecker, M.D., M.B.A. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AR-13324 Ophthalmic Solution 0.01% | 1 drop to study eye once daily (QD) in the morning (AM) |
| FG001 | AR-13324 Ophthalmic Solution 0.02% | 1 drop to study eye once daily (QD) in the morning (AM) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| AR-13324 Ophthalmic Solution 0.02% | Drug | Administered to study eye, QD AM for 7 days |
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| AR-13324 Ophthalmic Solution 0.04% | Drug | Administered to study eye, QD AM for 7 days |
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| AR-13324 Ophthalmic Solution Vehicle | Other | Administered to study eye, QD AM for 7 days |
|
| Fairfield |
| Connecticut |
| 06824 |
| United States |
| Coastal Research Associates, LLC | Roswell | Georgia | 30076 | United States |
| Heart of America Eye Care, P.A. | Shawnee Mission | Kansas | 66204 | United States |
| Comprehensive Eye Care | St Louis | Missouri | 63090 | United States |
| Rochester Ophthalmology Group | Rochester | New York | 14618 | United States |
| The Eye Institute | Tulsa | Oklahoma | 74104 | United States |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Univ Eye Surgeons, Maryville Ctr. | Maryville | Tennessee | 37803 | United States |
| Texan Eye | Austin | Texas | 78731 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| FG002 | AR-13324 Ophthalmic Solution 0.04% | 1 drop to study eye once daily (QD) in the morning (AM) |
| FG003 | AR-13324 Opththalmic Solution Vehicle | 1 drop to study eye once daily (QD) in the morning (AM) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AR-13324 Ophthalmic Solution 0.01% | 1 drop to study eye once daily (QD) in the morning (AM) |
| BG001 | AR-13324 Ophthalmic Solution 0.02% | 1 drop to study eye once daily (QD) in the morning (AM) |
| BG002 | AR-13324 Ophthalmic Solution 0.04% | 1 drop to study eye once daily (QD) in the morning (AM) |
| BG003 | AR-13324 Ophthalmic Solution Vehicle | 1 drop to study eye once daily (QD) in the morning (AM) |
| BG004 | 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 |
| |||||||||||||||
| 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 outcome was the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8. Instillation of study treatment commenced on Day 2 following measurement of IOP. IOP was measured at 0800, 1000, 1200 and 1600 hours on days 2 and 8. IOP was also measured at 0800 hours on Day 4. | Modified intent to treat (mITT) population (85 patients receiving investigational treatment). Participants who did not complete the study did not contribute data at later time points. | Posted | Mean | Standard Deviation | mmHg | Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8. |
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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 0.01% | 1 drop to study eye once daily (QD) in the morning (AM) | 0 | 22 | 0 | 22 | 12 | 22 |
| EG001 | AR-13324 Ophthalmic Solution 0.02% | 1 drop to study eye once daily (QD) in the morning (AM) | 0 | 21 | 0 | 21 | 15 | 21 |
| EG002 | AR-13324 Ophthalmic Solution 0.04% | 1 drop to study eye once daily (QD) in the morning (AM) | 0 | 19 | 0 | 19 | 17 | 19 |
| EG003 | AR-13324 Ophthalmic Solution Vehicle | 1 drop to study eye once daily (QD) in the morning (AM) | 0 | 23 | 0 | 23 | 1 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA (15.0) | Systematic Assessment |
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| Ocular Hyperaemia | Eye disorders | MedDRA (15.0) | Systematic Assessment |
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| Erythema of Eyelid | Eye disorders | MedDRA (15.0) | Systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA (15.0) | Systematic Assessment |
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| Diplopia | Eye disorders | MedDRA (15.0) | Systematic Assessment |
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| Dry Eye | Eye disorders | MedDRA (15.0) | Systematic Assessment |
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| Vitreous Floaters | Eye disorders | MedDRA (15.0) | Systematic Assessment |
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| Instillation Site Reaction | General disorders | MedDRA (15.0) | Systematic Assessment |
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| Corneal Staining | Investigations | MedDRA (15.0) | Systematic Assessment |
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| Blood Glucose Increased | Investigations | MedDRA (15.0) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Ramirez-Davis, Director Clinical Project Management | Aerie Pharmaceuticals, Inc. | 908-947-3543 | nramirez@aeriepharma.com |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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| ID | Term |
|---|---|
| C000603944 | netarsudil |
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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 2, 1000 hours |
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| Day 2, 1200 hours |
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| Day 2, 1600 hours |
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| Day 4, 0800 hours |
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| Day 8, 0800 hours |
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| Day 8, 1000 hours |
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| Day 8, 1200 hours |
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| Day 8, 1600 hours |
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