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| Name | Class |
|---|---|
| ActualEyes, Inc. | INDUSTRY |
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This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). This study will consist of a Screening Period of up to 15 days and an 18-month Double-Masked Treatment Period, including 9 individual visits to the study site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STN1010904 ophthalmic suspension 0.03% BID | Experimental |
| |
| STN1010904 ophthalmic suspension 0.1% BID | Experimental |
| |
| Placebo Vehicle BID | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STN1010904 ophthalmic suspension 0.03% BID | Drug | 0.03% STN1010904 ophthalmic suspension BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18 | at 18 month | |
| Change from baseline in BCVA with contrast level of 10% at Month 18 | at 18 month | |
| Change from baseline in contrast sensitivity with glare light at Month 18 | at 18 month |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits | up to month 18 | |
| BCVA with contrast level of 10% at all post-baseline visits | up to month 18 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stein Eye Institution UCLA | Los Angeles | California | 90095 | United States | ||
| Price Vision Group |
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| STN1010904 ophthalmic suspension 0.1% BID | Drug | 0.1% STN1010904 ophthalmic suspension BID |
|
| Placebo (Vehicle) BID | Drug | Placebo (vehicle) BID |
|
| Contrast sensitivity with glare light at all post-baseline visits |
| up to month 18 |
| Contrast sensitivity without glare light at all post-baseline visits | up to month 18 |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| Comprehensive Eye Care, Ltd | Washington | Missouri | 63090 | United States |
| Metropolitan Eye Research and Surgery Center | Palisades Park | New Jersey | 07650 | United States |
| Devers Eye Institute | Portland | Oregon | 97210 | United States |
| Scott Christie and Associates | Cranberry Township | Pennsylvania | 16066 | United States |
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Houston Eye Associates | Houston | Texas | 77025-1697 | United States |
| Fondation Ophtalmologique Adolphe de Rothschild | Paris | 75019 | France |
| University Hospital of Saint-Etienne | Saint-Etienne | 42055 | France |
| Medical Research Foundation | Chennai | Tamil Nadu | 600 006 | India |
| Suven Clinical Research CenterL V Prasad Eye Institute | Banjara Hills | Telangana | 500034 | India |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 14, 2026 | Jun 9, 2026 | 6 | ||
| Jun 24, 2026 |
| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
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