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| Name | Class |
|---|---|
| Kala Pharmaceuticals, Inc. | INDUSTRY |
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The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK). Topical corticosteroids have long been the mainstay for preventing and treating cornea transplant rejection although none are specifically approved for this purpose. The rates of immunologic rejection episodes and steroid-induced ocular hypertension will be compared with the respective rates observed in earlier studies with prednisolone acetate 1% suspension, loteprednol etabonate 0.5% gel, and fluorometholone 0.1% suspension after DMEK.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preventative Treatment | Experimental | Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| loteprednol etabonate 0.25% ophthalmic suspension | Drug | tapering dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunologic Rejection | incidence of immunologic rejection episodes | 11 months |
| Steroid-induced Ocular Hypertension | incidence of steroid-induced ocular hypertension | 11 months |
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Inclusion Criteria:
o At least 18 years of age
Exclusion Criteria:
o A history of a previous rejection episode in the study eye
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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 |
|---|---|---|---|
| 26020827 | Background | Price MO, Feng MT, Scanameo A, Price FW Jr. Loteprednol Etabonate 0.5% Gel Vs. Prednisolone Acetate 1% Solution After Descemet Membrane Endothelial Keratoplasty: Prospective Randomized Trial. Cornea. 2015 Aug;34(8):853-8. doi: 10.1097/ICO.0000000000000475. | |
| 25062336 | Background | Price MO, Price FW Jr, Kruse FE, Bachmann BO, Tourtas T. Randomized comparison of topical prednisolone acetate 1% versus fluorometholone 0.1% in the first year after descemet membrane endothelial keratoplasty. Cornea. 2014 Sep;33(9):880-6. doi: 10.1097/ICO.0000000000000206. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Preventative Treatment | Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam. loteprednol etabonate 0.25% ophthalmic suspension: tapering dose |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preventative Treatment | Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam. loteprednol etabonate 0.25% ophthalmic suspension: tapering dose |
| 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 | Immunologic Rejection | incidence of immunologic rejection episodes | Posted | Count of Participants | Participants | 11 months |
|
|
11 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 | Preventative Treatment | Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam. loteprednol etabonate 0.25% ophthalmic suspension: tapering dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Steroid induced intraocular pressure elevation | 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 | Nov 3, 2021 | Jul 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C562745 | Corneal Dystrophy, Posterior Polymorphous, 1 |
| D015715 | Corneal Edema |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| 37733966 | Result | Price MO, Feng MT, Gang A, Price FW Jr. Prospective Assessment of Loteprednol Etabonate 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty in Eyes With Fuchs Dystrophy. Cornea. 2024 Aug 1;43(8):1028-1030. doi: 10.1097/ICO.0000000000003398. Epub 2023 Sep 21. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Primary | Steroid-induced Ocular Hypertension | incidence of steroid-induced ocular hypertension | Posted | Count of Participants | Participants | 11 months |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 3 |
| 70 |
| Instillation site discomfort | Eye disorders | Systematic Assessment | Ocular discomfort associated with instillation of study eye drop |
|
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |