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Cornea transplant recipients who are using topical corticosteroids long-term to prevent transplant rejection will be randomized to use netarsudil or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Netarsudil | Experimental | Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months |
|
| Placebo | Placebo Comparator | Placebo eye drop, dosed topically once a day for 9 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netarsudil | Drug | netarsudil opthalmic solution 0.02% |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure | Intraocular pressure measurement exceeding 24 mm Hg or more than 10 mm Hg greater than the pre-randomization reading. | from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis W Price, Jr, MD | Price Vision Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27666015 | Background | Fini ME, Schwartz SG, Gao X, Jeong S, Patel N, Itakura T, Price MO, Price FW Jr, Varma R, Stamer WD. Steroid-induced ocular hypertension/glaucoma: Focus on pharmacogenomics and implications for precision medicine. Prog Retin Eye Res. 2017 Jan;56:58-83. doi: 10.1016/j.preteyeres.2016.09.003. Epub 2016 Sep 22. | |
| 19643499 | Background |
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As specified in the protocol, a total of 120 unique participants were enrolled in the study; 71 enrolled both eyes in the study and the fellow eyes were automatically assigned to opposite treatment arms, so 71 subjects participated in both treatment arms.
| ID | Title | Description |
|---|---|---|
| FG000 | Netarsudil | Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months Netarsudil: netarsudil opthalmic solution 0.02% |
| FG001 | Placebo | Placebo eye drop, dosed topically once a day for 9 months Placebo: Placebo eye drops |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Netarsudil | Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months Netarsudil: netarsudil opthalmic solution 0.02% |
| BG001 | Placebo | Placebo eye drop, dosed topically once a day for 9 months Placebo: Placebo eye drops |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Intraocular pressure measurement exceeding 24 mm Hg or more than 10 mm Hg greater than the pre-randomization reading. | Posted | Count of Participants | Participants | from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months |
|
9 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 | Netarsudil | Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months Netarsudil: netarsudil opthalmic solution 0.02% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Air re-injection | Eye disorders | Systematic Assessment | Air was re-injected into the eye to promote endothelial keratoplasty attachment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marianne Price | Cornea Research Foundation of America | 3178142990 | mprice@cornea.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2017 | Jan 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
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| ID | Term |
|---|---|
| C000603944 | netarsudil |
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| Drug |
Placebo eye drops |
|
| Vajaranant TS, Price MO, Price FW, Gao W, Wilensky JT, Edward DP. Visual acuity and intraocular pressure after Descemet's stripping endothelial keratoplasty in eyes with and without preexisting glaucoma. Ophthalmology. 2009 Sep;116(9):1644-50. doi: 10.1016/j.ophtha.2009.05.034. Epub 2009 Jul 29. |
| 33045216 | Derived | Price MO, Feng MT, Price FW Jr. Randomized, Double-Masked Trial of Netarsudil 0.02% Ophthalmic Solution for Prevention of Corticosteroid-Induced Ocular Hypertension. Am J Ophthalmol. 2021 Feb;222:382-387. doi: 10.1016/j.ajo.2020.09.050. Epub 2020 Oct 10. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| 31 |
| 95 |
| EG001 | Placebo | Placebo eye drop, dosed topically once a day for 9 months Placebo: Placebo eye drops | 0 | 96 | 0 | 96 | 18 | 96 |
|
| Ocular irritation considered related to study drug use | Eye disorders | Systematic Assessment |
|
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |