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The purpose of this study is to evaluate superior efficacy of DE-108 ophthalmic solution to that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for perioperative bacteria eradication in patients who are scheduled for cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-108 | Experimental | High concentration / Antibacterial Ophthalmic Solution |
|
| Levofloxacin 0.5% | Active Comparator | Low concentration / Antibacterial Ophthalmic Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-108 | Drug | Subjects will be assigned to receive DE-108 ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the percentage of positive bacteriological test results (from Day -3 to Day 0) | 3 days (Day -3 to Day0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Kyungpook | South Korea | ||||
| Asan Medical Center |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
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| Levofloxacin 0.5% | Drug | Subjects will be assigned to receive Levofloxacin 0.5% ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery. |
|
| Seoul |
| South Korea |
| Kim's eye Hospital | Seoul | South Korea |
| Seoul National University Bundang Hospital | Seoul | South Korea |
| Seoul Saint Marry's Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |