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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01FD003910 | U.S. FDA Grant/Contract | View source |
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This is an initial clinical trial evaluating whether different doses of iontophoresis for delivery of dexamethasone phosphate can be tolerated by eyes of patients with non-infections, non-necrotizing scleritis. A secondary goal is to get preliminary information about whether the treatment is likely to be an effective treatment for scleritis. If the results are favorable, further trials evaluating the treatment may be pursued.
Funding sources: FDA OOPD, Eyegate Pharmaceuticals, Inc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment at day 0 and day 7 | Experimental | Iontophoresis Delivery of Dexamethasone Phosphate (EGP-437) at one of three different iontophoretic doses. One treatment will be given at Day 0 (baseline) and one at Day 7. The three iontophoresis doses are:
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| Active Treatment at Day 0, Sham Treatment at Day 7 | Active Comparator | Iontophoresis Delivery of Dexamethasone Phosphate (EGP-437) at one of three different iontophoretic doses. One treatment will be given at Day 0 (baseline) and a sham treatment Day 7. The three iontophoresis doses are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Phosphate Ophthalmic Solution (EGP-437) | Drug | Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only). |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement on scleritis scale score | 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | United States | |||
| University of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29666122 | Derived | O'Neil EC, Huang J, Suhler EB, Dunn JP Jr, Perez VL, Gritz DC, McWilliams K, Peskin E, Ying GS, Bunya VY, Maguire MG, Kempen JH. Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial. Br J Ophthalmol. 2018 Aug;102(8):1011-1013. doi: 10.1136/bjophthalmol-2017-311610. Epub 2018 Apr 17. |
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| Dexamethasone phosphate ophthalmic solution | Drug | Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only) |
|
| Miami |
| Florida |
| United States |
| Wilmer Eye Institute/Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Montefiore Medical Center | The Bronx | New York | United States |
| Oregon Health & Sciences University | Portland | Oregon | United States |
| Scheie Eye Institute/University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| ID | Term |
|---|---|
| D015423 | Scleritis |
| ID | Term |
|---|---|
| D015422 | Scleral Diseases |
| D005128 | Eye Diseases |
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