Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AL-60371, 0.3% otic suspension, AL-60371, 0.3% Otic Suspension
AL-60371, 0.3% otic · 2 trials · 1 indication
An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. Proportion of patients is reported as percentage of participants.
| Arm | Type | Description |
|---|---|---|
| AL-60371 | EXPERIMENTAL | AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days |
| Vehicle | PLACEBO_COMPARATOR | AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days |
| Name | Type | Description |
|---|---|---|
| AL-60371, 0.3% otic suspension | DRUG | Investigational otic suspension intended for the treatment of acute otitis externa |
| AL-60371 Vehicle | DRUG | Inactive ingredients used as placebo |
Inclusion Criteria: * At least 6 months of age. * Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear. * Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema....
AL-60371, 0.3% otic is being developed for the treatment of acute otitis externa, an infection of the outer ear canal. It is formulated as a topical otic suspension applied directly to the ear. The program is in Phase 3 development and is not yet approved.
AL-60371, 0.3% otic is being developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor of the clinical program evaluating the otic suspension in acute otitis externa.
AL-60371, 0.3% otic is in Phase 3 development. Two Phase 3 trials have been completed, and no trials are currently listed as active. The drug remains investigational and has not been approved for marketing.
Two completed Phase 3 trials have evaluated AL-60371, 0.3% otic in acute otitis externa: NCT01535599, which enrolled 768 participants, and NCT01535560, which enrolled 589 participants. Both were randomized, double-blind, placebo-controlled studies that included patients aged 6 months and older.
Yes. AL-60371, 0.3% otic and AL-60371, 0.3% otic suspension refer to the same investigational product from Alcon. The suspension describes the formulation used in the Phase 3 trials for acute otitis externa.
Across the two completed Phase 3 trials, 1,357 participants were enrolled in studies of AL-60371, 0.3% otic for acute otitis externa. NCT01535599 enrolled 768 participants and NCT01535560 enrolled 589, with both studies including patients aged 6 months and older.