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 2013-12-10.
Sponsored by Alcon Research (part of Alcon) · Phase 3, Interventional, and Treatment
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.
22 studies on the registry are indexed under Otitis Externa; 1 is open to participants now.
This study's enrollment of 589 is above the median of 100 across 20 interventional studies indexed under Otitis Externa.
Browse Otitis Externa studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
Drug: AL-60371, 0.3% otic suspension
AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
Drug: AL-60371 Vehicle
Investigational otic suspension intended for the treatment of acute otitis externa
Inactive ingredients used as placebo
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.
Time frame: Day 11
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.
Time frame: Day 11
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 frame: Time to event (Day 1 to Day 11)
Participants were recruited from 53 investigational centers located in the United States, Puerto Rico, and Canada.
| Milestone | AL-60371 | Vehicle |
|---|---|---|
| Started | 274 | 275 |
| Completed | 237 | 179 |
| Not completed | 37 | 96 |
| Withdrew: Adverse event | 12 | 7 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Subj decision unrel to an adverse event | 3 | 1 |
| Withdrew: Treatment failure | 21 | 83 |
| Withdrew: Other | 0 | 1 |
| Withdrew: Randomized in error | 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. Proportion of patients is reported as percentage of participants.
| Percentage of participants | AL-60371 | Vehicle |
|---|---|---|
| Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit | 68.7 | 40.0 |
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.
| Percentage of participants | AL-60371 | Vehicle |
|---|---|---|
| Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit | 66.0 | 11.5 |
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.
| Days | AL-60371 | Vehicle |
|---|---|---|
| Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary | 3.0 ± 0.2 | 6.5 ± 0.3 |
Collected over Adverse events were collected for the duration of the study (6 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AL-60371 | — | 0/274 (0%) | 0/274 (0%) |
| Vehicle | — | 0/274 (0%) | 0/274 (0%) |
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.
| Age, Customized(Participants) | AL-60371 | Vehicle | Total |
|---|---|---|---|
| Infants and Toddlers (28 days to 23 months) | 0 | 1 | 1 |
| Children (2 to 11 years) | 130 | 120 | 250 |
| Adolescents (12 to 17 years) | 56 | 62 | 118 |
| Adults (18 to 64 years) | 80 | 87 | 167 |
| Elderly (≥ 65 years) | 8 | 4 | 12 |
| Sex: Female, Male(Participants) | AL-60371 | Vehicle | Total |
|---|---|---|---|
| Female | 148 | 170 | 318 |
| Male | 126 | 104 | 230 |
No study locations are listed for this record.
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Finafloxacin