Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00961675 | FST-201 in the Treatment of Acute Otitis Externa | PHASE3 | COMPLETED | 70 | — | — | Aug 31, 2009 | Jun 30, 2010 | Jun 14, 2021 | 1 | American Samoa |
| Arm | Type | Description |
|---|---|---|
| FST201 | ACTIVE_COMPARATOR | - |
| Ciprodex | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| FST201 (dexamethasone 0.1% with povidone-iodine 1%) | DRUG | 4 gtt BID (twice a day) |
| Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% ) | DRUG | 4 gtt BID (twice a day) |
Inclusion Criteria: Study participants must: * Have a clinical diagnosis of AOE in one or both ears, defined as a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1) * Be at least 18 years of age at Visit 1 (Day 1, S...