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The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxidex | Experimental | Moxidex otic solution |
|
| FLOXIN | Active Comparator | Ofloxacin otic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxidex otic solution | Drug | 4 drops into the infected ear(s) twice daily (morning and evening) for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate at the test of cure visit as determined by the investigator | From baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Time to cessation of otorrhea | From baseline | |
| Microbiological outcome | From baseline | |
| Treatment failures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Contact Alcon Call Center | 1-888-451-3937 | Study Director |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Ofloxacin otic solution | Drug | 5 drops into the infected ear(s) twice daily (morning and evening) for 10 days |
|
|
| Tympanostomy tubes | Device | Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children |
|
| From baseline |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |