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To evaluate the IOP lowering efficacy of netarsudil ophthalmic solution 0.02% when used as monotherapy or when used concomitantly with other IOP-lowering agents in subjects with elevated IOP due to open angle glaucoma or ocular hypertension in a real-world clinical setting. The study is an open-label design. The patients will receive treatment for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Netarsudil Ophthalmic Solution 0.02% | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netarsudil Ophthalmic Solution 0.02% | Drug | 1 drop in each eye once daily in the evening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry. Prostaglandin analog (PGA). Fixed dose combination (FDC). | 12 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hollander, MD, MBA | Aerie Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantis Eyecare | Huntington Beach | California | 92647 | United States | ||
| Harvard Eye Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33733980 | Derived | Zaman F, Gieser SC, Schwartz GF, Swan C, Williams JM. A multicenter, open-label study of netarsudil for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension in a real-world setting. Curr Med Res Opin. 2021 Jun;37(6):1011-1020. doi: 10.1080/03007995.2021.1901222. Epub 2021 Mar 27. |
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The enrolled population includes all subjects who signed ICF. One subject enrolled but withdrew consent before study drug dispensed; thus, post-baseline treatment is unavailable. Participant Flow data represents ITT population. Clarification of enrolled (n= 261) vs treated (n=260) subjects is provided in Recruitment & Pre-assignment sections.
A total of 261 subjects were enrolled across 22 investigational sites and 260 treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Netarsudil Ophthalmic Solution 0.02% Monotherapy | Netarsudil Ophthalmic Solution 0.02% Monotherapy: 1 drop in each eye once daily in the evening. |
| FG001 | Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy |
| 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 | Dec 18, 2018 | Jul 28, 2020 |
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| Laguna Hills |
| California |
| 92653 |
| United States |
| North Bay Eye Associates, Inc | Petaluma | California | 94954 | United States |
| Shettle Eye Research Inc | Largo | Florida | 33773 | United States |
| Center For Sight | Sarasota | Florida | 34238 | United States |
| Coastal Research Associates, LLC | Roswell | Georgia | 30076 | United States |
| Wheaton Eye Clinic, Ltd | Wheaton | Illinois | 60187 | United States |
| Stiles Eyecare Excellence and Glaucoma Institute, PA | Overland Park | Kansas | 66213 | United States |
| Gaddie Eye Centers, LLC | Louisville | Kentucky | 40241 | United States |
| Glaucoma Consultants | Baltimore | Maryland | 21204 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| Mark J. Weiss, M.D., Inc. | Tulsa | Oklahoma | 74104 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Valley Eye Professionals, LLC | Huntingdon Valley | Pennsylvania | 19006 | United States |
| Carolina Cataract & Laser Center | Ladson | South Carolina | 29456 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| VRF Eye Specialty Group | Memphis | Tennessee | 38120 | United States |
| Advancing Vision Research | Nashville | Tennessee | 37204 | United States |
| Keystone Research | Austin | Texas | 78731 | United States |
| Cataract & Glaucoma Center | El Paso | Texas | 79902 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| The Eye Centers of Racine and Kenosha | Racine | Wisconsin | 53405 | United States |
Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
| COMPLETED |
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| NOT COMPLETED |
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Modified intent to treat (mITT) population included all subjects who received at least 1 dose of study medication and had at least 1 follow-up visit with a completed IOP measurement.
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| ID | Title | Description |
|---|---|---|
| BG000 | Netarsudil Ophthalmic Solution 0.02% Monotherapy | Netarsudil Ophthalmic Solution 0.02% Monotherapy - 1 drop in each eye once daily in the evening. |
| BG001 | Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy | Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening. |
| BG002 | 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 |
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| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
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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) | Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry. Prostaglandin analog (PGA). Fixed dose combination (FDC). | Modified Intent-to-Treat (mITT) population included all subjects who received at least 1 dose of study medication and had at least 1 follow-up visit with a completed IOP measurement. | Posted | Mean | Standard Deviation | percent change | 12 weeks |
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Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
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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 | Netarsudil Ophthalmic Solution 0.02% Monotherapy | Netarsudil Ophthalmic Solution 0.02% Monotherapy. 1 drop in each eye once daily in the evening. | 0 | 99 | 2 | 99 | 43 | 99 |
| EG001 | Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy | Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening. | 0 | 161 | 1 | 161 | 58 | 161 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis Lower Left Extremity | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| Malignant Melanoma of Eyelid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperemia | Eye disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Conjunctival Hemorrage | Eye disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Instillation Site Pain | Eye disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Medical Affairs | Aerie Pharmaceuticals | 949-246-8731 | jmwilliams@aeriepharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2019 | Jul 28, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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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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