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This is a Phase II Single Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel, Group Study to Assess the Efficacy of EBI-005 Topical Ophthalmic Solution for the Treatment of Moderate to Severe Allergic Conjunctivitis Using an Environmental Exposure Chamber (EEC) Model and Conjunctival Allergen Provocation Test (CAPT) Model. Approximately 150 subjects will be enrolled and randomized in one study center in Canada for a duration of 0.33 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator EBI-005 5 mg/mL | Active Comparator | Administered 3 times per day |
|
| Placebo Comparator | Placebo Comparator | Administered 3 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator EBI-005 5 mg/mL | Drug |
| ||
| Placebo Comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle | 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Adverse Events. | Frequency, severity and relationship to study medication of all Adverse Events occurring during the study. | up to 45 days |
| Evaluation of antibodies to EBI-005. | Number and percent of subjects who develop drug antibodies over time |
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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 |
|---|---|---|---|---|---|---|
| Investigation Site | Mississauga | Ontario | L4W 1A2 | Canada |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| Drug |
|
| up to 45 days |
| Evaluation of ocular changes | Changes in ophthalmic examinations over time. | up to 45 days |
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |