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In brief, the objective of this study is to investigate whether the drug Glanatec ® which is approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs endothelial dystrophy who have had a descemet stripping procedure without endothelial keratoplasty. While some limited data exists as a proof of concept in in vitro or animal studies, and Glanatec® has been successfully used in a recently published case series for this indication, there is insufficient data to show that this drug can be effectively used for corneal cell clearing while maintaining patient safety.
The goal of the study is to provide sufficient proof of concept for the use of this drug in patients with FED whose only treatment alternative is to undergo corneal transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glanatec(R) 3 times a day | Active Comparator |
| |
| Glanatec (R) 6 times a day | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ripasudil hydrochloride hydrate 0.4% ophthalmic solution | Drug | the ophthalmic solution will be administered three or six per times per day in the eye designated as the "Study Eye" upon study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Clearing | The first primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly increases corneal clearing at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping | 12 months |
| pachymetry measurement | The second primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly reduces the pachymetry measurement at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | The secondary aim of this study is to examine whether Glanatec® administered three or six times daily affects best corrected visual acuity at 12 months (measured by Snellen lines) as compared to baseline, patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping. | 12 months |
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Inclusion Criteria:
• Ability to understand read and sign the informed consent form.
Exclusion Criteria:
• Uncontrolled glaucoma (IOP >25 mmHg)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Duanny Alva, MPH | Contact | 847-570-1783 | dalva@northshore.org | |
| Marian Macsai, MD | Contact | 847-657-1936 | mmacsai@northshore.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Recruiting | Glenview | Illinois | 60026 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 11, 2023 | Jun 9, 2023 | 6 | ||
| Sep 20, 2023 |
| 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 |
|---|---|
| D009883 | Ophthalmic Solutions |
| C584679 | K-115 |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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|
| Sep 20, 2023 |
| 7 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |