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Also known as Moxidex otic solution
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:...
Moxidex otic is an investigational otic small molecule being developed for ear infections, specifically acute otitis externa and acute otitis media. It is studied in patients as young as 6 months, including children with tympanostomy tubes. It is not yet approved and remains in clinical development.
Moxidex otic is being developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor behind the clinical program evaluating the otic formulation in ear infection indications.
Moxidex otic is in Phase 3 development. Its program includes completed Phase 3 trials in acute otitis externa and acute otitis media with tympanostomy tubes, along with a completed Phase 2 study. It is investigational and has not been approved.
Moxidex otic has been evaluated in completed trials including NCT00750633 in acute otitis externa, NCT00579189 and NCT00578474 in acute otitis media with tympanostomy tubes, and NCT00578773, a Phase 2 study in peri-operative tube otorrhea. All four studies are completed.
Yes. Moxidex otic solution is another name for Moxidex otic, referring to the same otic formulation developed by Alcon Inc. for ear infection indications. Both names describe the same investigational small molecule product.
Across its clinical program, Moxidex otic trials enrolled about 1,990 patients in total. The studies were randomized, double-blind, and active-controlled, with participants as young as 6 months of age, reflecting a pediatric-focused development effort.