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The purpose of this study is to assess the safety and efficacy of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) using the EyeGate® II Iontophoresis system in patients with dry eye.
Dry eye is the most prevalent form of ocular discomfort and irritation. Estimates range from 20 million people in the United States being affected with mild to moderate dry eye, to as many as one out of every five Americans.
EyeGate completed a single-center, randomized, double-masked, placebo-controlled Phase 2 efficacy study in 105 subjects with mild to moderate dry eye disease, utilizing the Controlled Adverse Environment (CAE), a clinical model which allows for standardized measurement of dry eye signs and symptoms in the investigation of therapeutic agents. In this Phase 2 study, the improvements documented in dry eye signs and symptoms relative to the placebo group indicated that the ocular iontophoresis treatments with EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) had both a rapid onset of action and a long-term effectiveness.
The Phase 3 study is intended to confirm and extend the results from the Phase 2 study, utilizing the CAE model. The study is designed to assess the safety and efficacy of EGP-437 at two different dose levels: Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA and Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA compared to Ocular Iontophoresis with placebo (sodium citrate buffer solution) for the treatment of the signs and symptoms of dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocular Iontophoresis EGP-437, Low Dose | Active Comparator | Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA |
|
| Ocular Iontophoresis EGP-437, High Dose | Active Comparator | Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA |
|
| Ocular Iontophoresis Placebo | Placebo Comparator | Ocular Iontophoresis with Placebo 6.5 mA-min at 2.5 mA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone phosphate ophthalmic solution | Drug | Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sign: Differences in corneal fluorescein staining (inferior region, Ora Scale) Visit 1 Pre-CAE to Visit 6 compared to placebo; Symptom: Ocular discomfort at Visit 5 as compared to placebo | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sign: Corneal fluorescein staining (each region, Ora Scale); Symptom: Ocular discomfort pre- and post-CAE (Ora Scale) | Up to 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail L Torkildsen, MD | Andover Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Care Group | Waterbury | Connecticut | 06708 | United States | ||
| Central Maine Eye Care |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 29, 2020 | |
| Reset | Jan 20, 2021 | |
| Release | Jan 25, 2021 |
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| Sodium citrate buffer solution | Drug | Sodium citrate buffer solution 100 mM |
|
| Lewiston |
| Maine |
| 04240 |
| United States |
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| Reset | Feb 11, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 29, 2020 | Jan 20, 2021 | |||
| Jan 25, 2021 | Feb 11, 2021 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
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