A Phase 3 interventional study of AL-60371, 0.3% Otic Suspension and AL-60371 Vehicle in Acute Otitis Externa, sponsored by Alcon Research. Completed. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2014-07-08.
Sponsored by Alcon Research · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
Drug: AL-60371, 0.3% Otic Suspension
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
Other: AL-60371 Vehicle
Inactive ingredients used as a placebo comparator
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.
Time frame: Day 11
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.
Time frame: 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 frame: Time to event, up to Day 11
Participants were recruited from 68 investigational centers located in the United States, Puerto Rico, and Canada.
| Milestone | AL-60371 | Vehicle |
|---|---|---|
| Started | 347 | 346 |
| Completed | 297 | 250 |
| Not completed | 50 | 96 |
| Withdrew: Adverse event | 6 | 15 |
| Withdrew: Lost to follow-up | 3 | 4 |
| Withdrew: Subj decision unrelated to adverse event | 4 | 3 |
| Withdrew: Treatment failure | 33 | 66 |
| Withdrew: Bl culture + for group a strep | 0 | 1 |
| Withdrew: Bl culture + for yeast//fungi | 0 | 1 |
| Withdrew: Randomized in error | 2 | 4 |
| Withdrew: Did not use product | 1 | 0 |
| Withdrew: Other | 1 | 0 |
| Withdrew: Stopped medication | 0 | 1 |
| Withdrew: Noncompliance | 0 | 1 |
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.
| percentage of participants | AL-60371 | Vehicle |
|---|---|---|
| Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit | 71.7 | 33.3 |
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.
| percentage of participants | AL-60371 | Vehicle |
|---|---|---|
| Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit | 66.9 | 13.0 |
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.
| days | AL-60371 | Vehicle |
|---|---|---|
| Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary | 4.0 ± 0.2 | 7.0 ± 0.4 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AL-60371 | — | 0/344 (0%) | 0/344 (0%) |
| Vehicle | — | 1/342 (0.3%) | 0/342 (0%) |
| Event | AL-60371 | Vehicle |
|---|---|---|
| AnxietyPsychiatric disorders | 0/344 | 1/342 |
| GastroenteritisInfections and infestations | 0/344 | 1/342 |
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.
| Age, Customized(participants) | AL-60371 | Vehicle | Total |
|---|---|---|---|
| Infants/Toddlers (18 days to 23 months) | 3 | 2 | 5 |
| Children (2 to 11 years) | 61 | 83 | 144 |
| Adolescents (12 to 17 years) | 64 | 42 | 106 |
| Adults (18 to 64 years) | 195 | 186 | 381 |
| Elderly (≥ 65 years) | 21 | 29 | 50 |
| Sex: Female, Male(Participants) | AL-60371 | Vehicle | Total |
|---|---|---|---|
| Female | 202 | 183 | 385 |
| Male | 142 | 159 | 301 |
No study locations are listed for this record.
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