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The purpose of this study was to demonstrate superiority of AL-60371 relative to Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).
Participants or legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear medication use, and impact of ear pain on sleep and other daily activities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-60371, 0.3% otic suspension | Drug | Investigational otic suspension intended for the treatment of acute otitis externa |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit | 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. | Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit | Microbiological success was considered attained if all pre-therapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. Proportion of patients is reported as a percentage of participants. | Day 11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sally Schieb | Alcon Research | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42210509 | Derived | Edmunds A, Bentley C, Luckermann M, Voet B, Vente A. Efficacy and Safety of Finafloxacin Otic Suspension, 0.3% for the Treatment of Acute Otitis Externa: Results from two Phase III Randomized Clinical Studies. Ann Otol Rhinol Laryngol. 2026 May 28:34894261453726. doi: 10.1177/00034894261453726. Online ahead of print. |
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Of the 589 participants enrolled, 40 were exited from the study as screen failures prior to randomization. This reporting group includes all randomized participants.
Participants were recruited from 53 investigational centers located in the United States, Puerto Rico, and Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | AL-60371 | AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days |
| FG001 | Vehicle | AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This reporting group includes all randomized participants who received the study drug (ie, 548). Note: 1 participant in the Vehicle arm was randomized in error and did not receive the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | AL-60371 | AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days |
| BG001 | Vehicle | AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit | 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. | This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline. | Posted | Number | Percentage of participants | Day 11 |
|
Adverse events were collected for the duration of the study (6 months).
This reporting group includes all participants who received study drug. Adverse events were obtained as solicited comments from the study patients and as observations by the study investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AL-60371 | AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sally Schieb, Sr. Clinical Project Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| AL-60371 Vehicle | Drug | Inactive ingredients used as placebo |
|
| Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary | Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries. | Time to event (Day 1 to Day 11) |
| Subj Decision Unrel to an Adverse Event |
|
| Treatment Failure |
|
| Other |
|
| Randomized in Error |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days |
|
|
| Secondary | Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit | Microbiological success was considered attained if all pre-therapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. Proportion of patients is reported as a percentage of participants. | This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline. | Posted | Number | Percentage of participants | Day 11 |
|
|
|
| Secondary | Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary | Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries. | This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline, minus missing responses. | Posted | Median | Standard Error | Days | Time to event (Day 1 to Day 11) |
|
|
|
| 0 |
| 274 |
| 0 |
| 274 |
| EG001 | Vehicle | AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days | 0 | 274 | 0 | 274 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.