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This is a Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe allergic conjunctivitis (AC) three times daily for 4 weeks.
Approximately 250 subjects at approximately 8 centers in the US will be screened and enrolled into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Vehicle | Placebo Comparator | Placebo Comparator: One of two study arms: placebo topical administered 3 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBI-005 | Drug |
| ||
| Placebo Comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Morning ocular itching diary scores | To evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Late afternoon ocular itching diary scores | The key secondary endpoints are to evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season | 14 days |
| Evening ocular itching diary scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Goldstein, MD | Eleven Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morrow | Georgia | 30260 | United States | |||
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|
The key secondary endpoints are to evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season |
| 14 days |
| Louisville |
| Kentucky |
| 40206 |
| United States |
| Andover | Massachusetts | 01810 | United States |
| Investigational Site | Quincy | Massachusetts | 02169 | United States |
| Investigational Site | St Louis | Missouri | 63131 | United States |
| Charlotte | North Carolina | 28204 | United States |
| Investigational Site | Cincinnati | Ohio | 45238 | United States |
| Investigational Site | Mason | Ohio | 45040 | United States |
| Investigational Site | Philadelphia | Pennsylvania | 19134 | United States |
| Memphis | Tennessee | 38119 | United States |
| San Antonio | Texas | 78209 | United States |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000604245 | EBI-005 |
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