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The purpose of this study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with non-infectious anterior segment uveitis.
This is a randomized, double-masked, parallel group, dose-comparison, exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infectious anterior segment uveitis. The current study will evaluate the safety, tolerability, and efficacy of this technology at the four dose levels to determine a safe effective dose appropriate for future trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGP-437 1.6 mA-min at 0.4 mA | Active Comparator | Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA |
|
| EGP-437 4.8 mA-min at 1.2 mA | Active Comparator | Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA |
|
| EGP-437 10.0 mA-min at 2.5 mA | Active Comparator | Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA |
|
| EGP-437 14.0 mA-min at 3.5 mA | Active Comparator | Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGP-437 1.6 mA-min at 0.4 with EyeGate® II System | Drug | Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with an ACC score of zero at Days 14 and 28 | Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28 | Prospective study, subjects followed for 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to ACC score of zero | Time to anterior chamber cell score of zero | Prospective study, subjects followed for 28 days |
| Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28 |
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Inclusion Criteria:
• Non-infectious anterior uveitis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C. Stephen Foster, MD | Massachusetts Eye Research and Surgery Institution | Principal Investigator |
| Michael Raizman, MD | Ophthalmic Consultants of Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| Emory Eye Center |
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|
| EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System | Drug | Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System |
|
|
| EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System | Drug | Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System |
|
|
| EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System | Drug | Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System |
|
|
Proportion of subjects with a reduction of one full anterior chamber cell score or more (≥ 0.5 decrease) from baseline at Day 28
| Prospective study, subjects followed for 28 days |
| Change from baseline in ACC score at Day 28 | Change from baseline in anterior chamber cell score at Day 28 | Prospective study, subjects followed for 28 days |
| Treatment emergent adverse events | Treatment emergent adverse events | Prospective study, subjects followed for 28 days |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Massachusetts Eye Research and Surgery Institution | Cambridge | Massachusetts | 02142 | United States |
| Comprehensive Eye Care Ltd. | Washington | Missouri | 63090 | United States |
| New York Eye & Ear Infirmary | New York | New York | 10003 | United States |
| Cleveland Eye Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health Services University | Portland | Oregon | 97239 | United States |
| Pennsylvania College of Optometry | Elkins Park | Pennsylvania | 19027 | United States |
| Scheie Eye Institue | Philadelphia | Pennsylvania | 19104 | United States |
| Southern College of Optometry | Memphis | Tennessee | 38104 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| St. Johns Medical College and Hospital | Bangalore | Karnataka | 560 037 | India |
| Vittala International Institute of Ophthalmology | Bangalore | Karnataka | 560 037 | India |
| Narayana Nethralaya | Bangalore | Karnataka | 560010 | India |
| M. M. Joshi Eye Institute | Hubli | Karnataka | 580 021 | India |
| Kasturba Medical College and Hospital | Manipal | Karnataka | 576104 | India |
| Christian Medical College | Vellore | Tamil Nadu | 632011 | India |
| ID | Term |
|---|---|
| D014606 | Uveitis, Anterior |
| ID | Term |
|---|---|
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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