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The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.
This will be a Phase 3, randomized, double-masked, parallel arm, positive-controlled non-inferiority study, in which up to 250 subjects (approximately 125 subjects per treatment arm) will be enrolled at up to 60 clinical sites. Patients with non-infectious anterior segment uveitis who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include BCVA, slit lamp examination, fundus exam, IOP by tonometry will be used to determine eligibility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone Phosphate Ophthalmic Solution | Experimental | Dexamethasone phosphate ophthalmic solution (40 mg/mL) |
|
| Prednisolone Acetate Ophthalmic (1%) | Active Comparator | Prednisolone Acetate Ophthalmic (1%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Phosphate Ophthalmic Solution | Drug | 40 mg/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with an AC cell count of zero at Day 14 | Day 14 ± 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John D. Sheppard, M.D. | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 14, 2020 | |
| Reset | Jan 7, 2021 |
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| Prednisolone Acetate Ophthalmic (1%) | Drug | Prednisolone Acetate (1%) |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 14, 2020 | Jan 7, 2021 |
| ID | Term |
|---|---|
| D014606 | Uveitis, Anterior |
| ID | Term |
|---|---|
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C036266 | prednylidene |
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