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The objective of this study is to evaluate the effect on corneal endothelial cell density changes when ISV-403 is administered for five (5) days compared to no drug treatment, in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Besifloxacin Ophthalmic Suspension 0.6% | Experimental | Topical ocular administration three times daily (TID) for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Besifloxacin Ophthalmic Suspension 0.6% | Drug | administered 3 times a day for 5 days to one eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial cell density change between treatment group. | Difference in the change from baseline in endothelial cell density between eyes treated with besifloxacin ophthalmic suspension and untreated fellow eyes. | Baseline, 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial cell density change within treatment group | Change from baseline in endothelial cell density within eyes treated with besifloxacin ophthalmic suspension and within untreated fellow eyes. | Baseline, 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Trusso, MS | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
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