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This is an open-label, randomized, single-dose, placebo-controlled efficacy study to assess the antimicrobial efficacy of ALT005 ophthalmic prep solution following dermal administration in healthy volunteers. Efficacy will be assessed by comparing the reduction in microbial load for up to 6 hours to that of saline control.
A total of 45 subjects who meet the criteria for inclusion will receive either ALT005 or control solution (sterile 0.9% saline) on one occasion to sites on the forehead and the cheeks. Subjects will be randomized in a ratio of 2:1 active:control. Subjects will be dosed in groups.
The study will run at one study center in the US. Subjects will be housed in the clinical research facility from the morning of Day -4 until the evening of Day 1. The total duration of participation for each subject dosed is approximately 21 days (from Day -19 study orientation through the follow-up call on Day 2, excluding the initial screening period).
In this study, the efficacy of ALT005 will be assessed in healthy volunteers who, after refraining voluntarily from using topical and oral antimicrobials for at least 2 weeks (14 days), exhibit acceptably high normal flora counts on the designated skin testing sites.
An additional cohort was added (3 ALT005, 6 Comparator Product) to make a non-statistical comparison of efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALT005 Ophthalmic Prep Solution | Experimental |
| |
| saline control | Placebo Comparator |
| |
| Comparator Product | Experimental | Betadine ophthalmic prep solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALT005 Ophthalmic Prep Solution | Drug | single application for up to 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 log10 reduction in microbial load | 3 log10 reduction in microbial load at 10 minutes following application to the forehead or cheek compared to Day 1 baseline. | 10 minutes post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 3 log10 reduction in microbial load | 3 log10 reduction in microbial load at 45 minutes following application to the forehead or cheek compared to Day 1 baseline. | 45 minutes post dose |
| 3 log10 reduction in microbial load |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Connolly, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion Inc | Neptune City | New Jersey | 07753 | United States |
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| saline control | Other | single application for up to 6 hours |
|
| Betadine ophthalmic prep solution | Drug | single application for up to 6 hours |
|
3 log10 reduction in microbial load at 6 hours following application to the forehead compared to Day 1 baseline.
| 6 hours post dose |