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The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active comparator Timolol Maleate Ophthalmic Solution, 0.5%.
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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) and 1 drop placebo in the morning (AM) in both eyes (OU) |
|
| AR-13324 Ophthalmic Solution 0.02% BID | Experimental | 1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) |
|
| Timolol maleate Ophthalmic Solution 0.5% BID | Active Comparator | 1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR-13324 Ophthalmic Solution 0.02% | Drug | 1 drop once daily (QD), PM, OU |
|
| 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:
Ophthalmic:
Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
Intraocular pressure ≥27 mm Hg (unmedicated) in both eyes (individuals who are excluded for this criterion are not allowed to attempt requalification), or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications.
Known hypersensitivity to any component of the formulations to be used (benzalkonium chloride, etc.), to topical anesthetics or β-adrenoceptor antagonists.
Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye.
Refractive surgery in either eye (e.g., radial keratotomy, PRK (photorefractive keratectomy), LASIK (laser eye surgery), corneal cross-linking, etc.).
Ocular trauma in either eye within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening.
Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or zoster keratitis at screening in either eye.
Ocular medication in either eye of any kind within 30 days of screening, 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 screening) or c) lubricating drops for dry eye (which may be used throughout the study).
Clinically significant ocular disease in either eye (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., cup-disc ratio > 0.8, severe visual field defect).
Central corneal thickness in either eye greater than 600 µm at screening.
Any abnormality in either eye preventing reliable applanation tonometry of either eye.
Systemic:
Clinically relevant abnormalities (as determined by the investigator) in laboratory tests at screening which may impact the study.
Known hypersensitivity or contraindication to beta-adrenoceptor antagonists (e.g., chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third degree heart block or congestive heart failure; severe diabetes).
Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
Participation in any investigational study within 30 days prior to screening.
Changes of systemic medication that could have an effect on IOP within 30 days prior to screening, or anticipated during the study.
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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nancy Ramirez | Bedminster | New Jersey | 07921 | United States |
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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 | AR-13324 Ophthalmic Solution 0.02% BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AR-13324 Ophthalmic Solution 0.02% BID | Drug | 1 drop BID, AM/PM, OU |
|
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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 |
|
1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
| FG002 | Timolol Maleate Ophthalmic Solution 0.5% BID | 1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) |
| COMPLETED |
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| NOT COMPLETED |
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Randomized Population
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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 | AR-13324 Ophthalmic Solution 0.02% BID | 1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) |
| BG002 | Timolol Maleate Ophthalmic Solution 0.5% BID | 1 drop Timolol maleate twice daily (BID) in the morning (AM) and 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, 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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| Region of Enrollment | Number | 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 | Extent of Exposure | Exposure to study medication in days for all treatment groups | Safety Population | Posted | Mean | Standard Deviation | days | 12 months |
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1 year (12 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) | 0 | 34 | 0 | 34 | 33 | 34 |
| EG001 | AR-13324 Ophthalmic Solution 0.02% BID | 1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) | 0 | 36 | 1 | 36 | 36 | 36 |
| EG002 | Timolol Maleate Ophthalmic Solution 0.5% BID | 1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) | 0 | 23 | 1 | 23 | 15 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Anterior Uveitis | Eye 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 |
| |
| Corneal Verticillata | 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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| Conjunctival Haemorrhage | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eyelid Oedema | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Corneal Opacity | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Conjunctival Oedema | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eye Pruritis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eyelids Pruritus | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Foreign Body Sensation in Eye | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Lenticular Opacities | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Conjunctivochalasis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eye Discharge | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Conjunctivitis Allergic | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eye Allergy | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Eyelid Pain | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Optic Disc Haemorrhage | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Dry Eye | 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 Discomfort | 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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| Instillation Site Pruritus | 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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| Intraocular Pressure Increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Blood Triglycerides Increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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Enrollment was discontinued after 93 participants were enrolled due to slow enrollment; all participants who entered the study were followed until study completion.
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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 |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| 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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