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The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Netarsudil | Active Comparator | A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night. |
|
| Placebo | Placebo Comparator | A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netarsudil Ophthalmic Solution | Drug | Netarsudil eye drops instilled once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Central Corneal Thickness | Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Corrected Distance Visual Acuity (CDVA) | Change in CDVA (lines read on the eye chart at 3 months minus lines read at baseline) | 3 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 |
|---|---|---|---|
| 33737034 | Result | Price MO, Price FW Jr. Randomized, Double-Masked, Pilot Study of Netarsudil 0.02% Ophthalmic Solution for Treatment of Corneal Edema in Fuchs Dystrophy. Am J Ophthalmol. 2021 Jul;227:100-105. doi: 10.1016/j.ajo.2021.03.006. Epub 2021 Mar 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Netarsudil | A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night. Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily |
| FG001 | Placebo | A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night. Placebo: Placebo eye drops instilled once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Netarsudil | A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night. Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Central Corneal Thickness | Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline | Posted | Mean | 95% Confidence Interval | microns | 1 month |
|
3 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 | A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night. Netarsudil Ophthalmic Solution: Netarsudil eye drops instilled once daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| conjunctival hyperemia | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marianne Price | Cornea Research Foundation of America | 317-814-2990 | 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 | Feb 18, 2020 | Aug 27, 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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The active drug and placebo will be provided in 2.5 ml bottles identical, in appearance. Only the designated dosing coordinator is unmasked.
| Placebo | Drug | Placebo eye drops instilled once daily |
|
|
A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night.
Placebo: Placebo eye drops instilled once daily
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Corrected Distance Visual Acuity (CDVA) | Change in CDVA (lines read on the eye chart at 3 months minus lines read at baseline) | Posted | Mean | 95% Confidence Interval | lines on the eye chart | 3 months |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 6 |
| 15 |
| EG001 | Placebo | A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night. Placebo: Placebo eye drops instilled once daily | 0 | 14 | 0 | 14 | 3 | 14 |
| ocular irritation | Eye disorders | Non-systematic Assessment |
|
| glare | Eye disorders | Non-systematic Assessment |
|
| lacrimation | Eye disorders | Non-systematic Assessment |
|
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |