Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Moxidex otic · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Moxidex | EXPERIMENTAL | Moxidex otic solution |
| Moxifloxacin | ACTIVE_COMPARATOR | Moxifloxacin otic solution |
| Dexamethasone | ACTIVE_COMPARATOR | Dexamethasone phosphate otic solution |
| FLOXIN | ACTIVE_COMPARATOR | Ofloxacin otic solution |
| TT only | OTHER | Tympanostomy tubes only |
| Name | Type | Description |
|---|---|---|
| Moxidex otic solution | DRUG | 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days |
| Moxifloxacin otic solution | DRUG | 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days |
| Dexamethasone phosphate otic solution | DRUG | 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days |
| Tympanostomy tubes | DEVICE | Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media with effusion in children |
| Ofloxacin otic solution | DRUG | 5 drops into the infected ear(s) twice daily (morning and evening) for 10 days |
Inclusion Criteria: * Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin * A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema * Other protocol-defined inclusion criteria may apply Exclusion Criteria:...