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Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once Daily Netarsudil Ophthalmic Solution | Experimental | One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects. |
|
| Twice Daily Netarsudil Ophthalmic Solution | Experimental | One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netarsudil Ophthalmic | Drug | Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central Corneal Thickness (CCT) | Mean change from baseline in CCT by ultrasound pachymetry | Baseline & 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Senchyna, Ph.D. | Aerie Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Ophthalmology | Garden Grove | California | 92843 | United States | ||
| Harvard Eye Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36327101 | Derived | Lindstrom RL, Lewis AE, Holland EJ, Sheppard JD, Hovanesian JA, Senchyna M, Hollander DA. Phase 2, Randomized, Open-Label Parallel-Group Study of Two Dosing Regimens of Netarsudil for the Treatment of Corneal Edema Due to Fuchs Corneal Dystrophy. J Ocul Pharmacol Ther. 2022 Dec;38(10):657-663. doi: 10.1089/jop.2022.0069. Epub 2022 Nov 3. |
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All participants underwent a washout of their pre-study treatment for Fuchs Corneal Dystrophy for a period of 24 hours prior to the baseline visit.
Recruitment took place at 12 clinic sites in the United States between September 2020 and June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Once Daily Netarsudil Ophthalmic Solution | One drop of study artificial tear in the study eye in the morning, and one drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects. Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Modified Intent-to-Treat Population |
|
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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 | Feb 3, 2021 | Aug 10, 2022 |
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| Netarsudil Ophthalmic | Drug | Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution |
|
|
| Laguna Hills |
| California |
| 92653 |
| United States |
| Cincinnati Eye Institute | Edgewood | Kentucky | 41017 | United States |
| Advance Eye Associates | South Dartmouth | Massachusetts | 02748 | United States |
| Chu Vision Institute | Bloomington | Minnesota | 55420 | United States |
| Minnesota Eye Care | Minnetonka | Minnesota | 55305 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Vance Thompson Vision | West Fargo | North Dakota | 58078 | United States |
| Comprehensive Eye Care | Westerville | Ohio | 43082 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| FG001 |
| Twice Daily Netarsudil Ophthalmic Solution |
One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects. Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution |
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| NOT COMPLETED |
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| Safety Population |
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| Per-Protocol Population |
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| Study Completion |
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40 participants were randomized; 20 each to the Netarsudil QD and the Netarsudil BID arms. 1 participant discontinued from each arm due to adverse events.
40 participants were included in both the mITT population for the primary endpoint analysis and the safety population for safety analysis.
6 participants were excluded from the per-protocol analysis due to protocol deviations (2 in the Netarsudil QD arm, 4 in the Netarsudil BID arm). There were no Covid-19 related protocol deviations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Once Daily Netarsudil Ophthalmic Solution | One drop of study artificial tear in the study eye in the morning, and one drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects. Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution |
| BG001 | Twice Daily Netarsudil Ophthalmic Solution | One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects. Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution |
| 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Central Corneal Thickness (CCT) | Mean change from baseline in CCT by ultrasound pachymetry | Modified Intent-to-Treat Population | Posted | Mean | Standard Deviation | µm | Baseline & 4 weeks |
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Adverse events were documented from the time of signing the informed consent until the last study visit for each participant. This was a period of approximately 8 weeks (56 days) for participants who completed the full study duration. For AEs ongoing at the time of study completion, the ongoing AE was followed-up and the participant was provided appropriate medical care until the event resolved or stabilized, the participant was lost to follow-up, or there was other resolution to the event.
Adverse events information was collected at all study visits.
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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 | Once Daily Netarsudil Ophthalmic Solution | One drop of study artificial tear in the study eye in the morning, and one drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects. Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution | 0 | 20 | 0 | 20 | 5 | 20 |
| EG001 | Twice Daily Netarsudil Ophthalmic Solution | One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects. Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution | 0 | 20 | 1 | 20 | 7 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal verticillata | Eye disorders | Systematic Assessment |
| ||
| Conjunctival hypaeremia | Eye disorders | Systematic Assessment |
| ||
| Erythema of eyelid | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Senchyna, PhD. VP, Clinical Development and Medical Affairs. | Aerie Pharmaceuticals Inc. | +1 908-947-3551 | msenchyna@aeriepharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2021 | Aug 10, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015715 | Corneal Edema |
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D003317 | Corneal Dystrophies, Hereditary |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| >=65 years |
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| Male |
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| White |
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