Trial · NCT01535599
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
NCT01535599, Phase 3, Completed, Alcon Research; results first posted 2014-06-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa. Trials, record NCT01535599. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01535599
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
- NCT number
- NCT01535599
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 768 participants, actual
- Lead sponsor
- Alcon Research
- Conditions
- Acute Otitis Externa
- Interventions
- AL-60371, 0.3% Otic Suspension, AL-60371 Vehicle
- First posted
- 2012-02-20
- Last updated
- 2014-07-08
- Results first posted
- 2014-06-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit | Day 11 | 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. |
| Secondary | Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit | Day 11 | 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. |
| Secondary | Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary | Time to event, up to Day 11 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit | Day 11 | 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. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit | Day 11 | 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. | percentage of participants | NUMBER |
| SECONDARY | Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary | Time to event, up to Day 11 | 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. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit | AL-60371 | 71.7 | percentage of participants | ||
| Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit | Vehicle | 33.3 | percentage of participants | ||
| Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit | AL-60371 | 66.9 | percentage of participants | ||
| Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit | Vehicle | 13.0 | percentage of participants | ||
| Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary | AL-60371 | 4.0 | Standard Error 0.2 | days | |
| Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary | Vehicle | 7.0 | Standard Error 0.4 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AL-60371 | 347 | |
| Overall Study | STARTED | Vehicle | 346 | |
| Overall Study | COMPLETED | AL-60371 | 297 | |
| Overall Study | COMPLETED | Vehicle | 250 | |
| Overall Study | NOT COMPLETED | AL-60371 | 50 | |
| Overall Study | NOT COMPLETED | Vehicle | 96 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Anxiety | Psychiatric disorders | AL-60371 | 0 | 344 | |
| serious | Anxiety | Psychiatric disorders | Vehicle | 1 | 342 | |
| serious | Gastroenteritis | Infections and infestations | AL-60371 | 0 | 344 | |
| serious | Gastroenteritis | Infections and infestations | Vehicle | 1 | 342 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AL-60371 | ||
| Total, all-cause mortality | Vehicle | ||
| Total, other adverse events | AL-60371 | 0 | 344 |
| Total, other adverse events | Vehicle | 0 | 342 |
| Total, serious adverse events | AL-60371 | 0 | 344 |
| Total, serious adverse events | Vehicle | 1 | 342 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| AL-60371 vs Vehicle: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01535599
GET https://conductscience.org/api/trials/v1/NCT01535599/registered