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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCN01 | Experimental |
| |
| Unisol | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCN01 | Drug | Three serial applications per periocular region. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in periocular region bacterial load | Baseline to 10 min post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of periocular regions with a reduction from baseline in bacterial load. | Baseline to 10 min post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (reported, elicited, observed) | Post dose and up to 2 weeks after (Day 1-14) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
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| Unisol |
| Drug |
Three serial applications per periocular region. |
|
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C513328 | UHK solution |
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