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The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye.
The objective of this study is to assess the safety and efficacy of Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 7.5 mA-min at 2.5 mA and Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 10.5 mA-min at 3.5 mA compared to placebo for the treatment of the signs and symptoms of dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose: DP 7.5 mA-min at 2.5 mA | Active Comparator | Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA |
|
| High Dose: DP 10.5 mA-min at 3.5 mA | Active Comparator | Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 10.5 mA-min at 3.5 mA |
|
| Placebo: 10.5 mA-min at 3.5 mA | Placebo Comparator | Ocular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGP-437 with EyeGate® II System | Drug | Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System |
| Measure | Description | Time Frame |
|---|---|---|
| Sign: Corneal fluorescein staining after CAE exposure at Visit 5 | Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale. | Visit 5 (Day 7 ± 2 Days) |
| Symptom: Ocular discomfort during CAE exposure at Visit 5 | Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale. | Visit 5 (Day 7 ± 2 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| Sign: Fluorescein staining at each visit over 3 weeks | Fluorescein staining (each region) as measured by the ORA and NEI Scales at each of 7 visits over 3 weeks | 7 visits / 3 weeks |
| Symptom: Ocular discomfort pre and post CAE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Torkildsen, MD | ORA, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Associates | Andover | Massachusetts | 01810 | United States | ||
| Ophthalmic Research Associates |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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|
| Sodium citrate buffer solution with EyeGate® II System | Drug | Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System |
|
|
Symptom: Ocular discomfort pre and post CAE (ORA Scale)at 3 visits (Visits 1, 3, and 5)
| Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days) |
| North Andover |
| Massachusetts |
| 01845 |
| United States |