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The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).
Patients were evaluated for safety and efficacy during the visits conducted at Day 3 (on-therapy), Day 8 (end-of-therapy), and Day 11 (TOC). Patients or parents/legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear pain medication use, and the 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 to the affected ear(s) twice daily for 7 days |
|
| Vehicle | Placebo Comparator | AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-60371, 0.3% Otic Suspension | Drug |
| ||
| AL-60371 Vehicle |
| 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. In this analysis, the clinical cure outcome at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage. | 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 pretherapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. In this analysis, the microbiological success value at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sally Scheib, Sr. Clinical Project Lead | 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 768 consented participants, 75 were exited from the study as screen failures prior to randomization. This reporting group includes all randomized participants (693).
Participants were recruited from 68 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 to the affected ear(s) twice daily for 7 days |
| FG001 | Vehicle | AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This reporting group includes all randomized participants who were treated with study medication (686). Note: 6 participants were randomized in error and did not receive study medication (3 in AL-60371 and 3 in Vehicle). Additionally 1 participant randomized to Vehicle exited the study at Visit 2 without dosing the study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | AL-60371 | AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days |
| BG001 | Vehicle | AL-60371 Vehicle, 4 drops to 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. In this analysis, the clinical cure outcome at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage. | This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline. | Posted | Number | percentage of participants | Day 11 |
|
Adverse events (AE) were collected for the duration of the study (1 year, 2 months). An AE was considered to be any untoward medical occurrence in a participant who was exposed to the study medication, regardless of causal relationship.
This reporting group includes all randomized participants who were treated with study medication (686). AEs were obtained as solicited comments from the study participants 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 to the affected ear(s) twice daily for 7 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sally Scheib, Sr. Clinical Project Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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Inactive ingredients used as a placebo comparator |
|
| Day 11 |
| Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary | Cessation of ear pain was defined as occurring on the first time point that ear pain was absent (morning or evening) and did not return in any subsequent diary entries. Day 1 was the starting point for this time-to-event analysis. For this analysis, all patients who did not complete the study and ear pain never ceased had their ear pain considered as being present throughout the planned duration of the study. | Time to event, up to Day 11 |
| Subj Decision Unrelated to Adverse Event |
|
| Treatment Failure |
|
| BL Culture + for Group A Strep |
|
| BL Culture + for Yeast//Fungi |
|
| Randomized in Error |
|
| Did not use product |
|
| Other |
|
| Stopped medication |
|
| Noncompliance |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Vehicle | AL-60371 Vehicle, 4 drops to 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 pretherapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. In this analysis, the microbiological success value at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage. | This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline. | Posted | Number | percentage of participants | Day 11 |
|
|
|
| Secondary | Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary | Cessation of ear pain was defined as occurring on the first time point that ear pain was absent (morning or evening) and did not return in any subsequent diary entries. Day 1 was the starting point for this time-to-event analysis. For this analysis, all patients who did not complete the study and ear pain never ceased had their ear pain considered as being present throughout the planned duration of the study. | This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline. Patients who did not report ear pain at any diary entry during first 7 days of the study were excluded from the analysis. | Posted | Median | Standard Error | days | Time to event, up to Day 11 |
|
|
|
| 0 |
| 344 |
| 0 |
| 344 |
| EG001 | Vehicle | AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days | 1 | 342 | 0 | 342 |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
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