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This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and Canada.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: EBI-005 | Active Comparator | Drug: EBI-005 The investigational drug EBI-005, is an intervention to one of two study arms: 5 mg/mL topical administered 3 times per day |
|
| Placebo or Vehicle control Comparator | Placebo Comparator | One of two study arms: placebo or vehicle control topical administered 3 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBI-005 | Drug | EBI-005 is an intervention into one of two (2) study arms; 5 mg/mL topical administered 3 times per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of EBI-005 (vital signs) | Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time. | 1 year |
| tolerability of EBI-005 (adverse events) | Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time. | 1 year |
| Immunogenicity of EBI-005 (assessment of antibody development (immunogenicity) over time) | Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time. | 1 year |
| Safety of EBI-005 (laboratory changes over time) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Biological effect of EBI-005 (Changes over time in the OSDI) | Changes over time in the OSDI. | 1 year |
| Biological effect of EBI-005 (Total corneal fluorescein staining) | 1 year |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Goldstein, MD | Eleven Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000604245 | EBI-005 |
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| Placebo | Drug | Placebo or Vehicle control comparator is an intervention into one of two (2) study arms; vehicle topical administered 3 times per day |
|
| Newport Beach |
| California |
| 92663 |
| United States |
| Hamden | Connecticut | 06518 | United States |
| New Albany | Indiana | 47150 | United States |
| Louisville | Kentucky | 40206 | United States |
| Winchester | Massachusetts | 01890 | United States |
| St Louis | Missouri | 63131 | United States |
| Asheville | North Carolina | 28803 | United States |
| Mason | Ohio | 45040 | United States |
| Cranberry Township | Pennsylvania | 16066 | United States |
| Memphis | Tennessee | 38119 | United States |
| San Antonio | Texas | 78229 | United States |