Acute Otitis ExternaPhase 3NCT01535599
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
A Phase 3 study testing AL-60371, 0.3% Otic Suspension in people with Acute Otitis Externa, run by Alcon Research.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Acute Otitis Externa
- What is being tested?
- AL-60371, 0.3% Otic Suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 768 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to May 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least 6 months of age.
- Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear.
- Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema.
- Agree to refrain from water immersion of the ears during the conduct of the entire study.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as reported by patient or parent/guardian.
- Presence of a tympanostomy tube or perforated tympanic membrane in the affected ear(s).
- Clinically diagnosed otic disease other than AOE (eg, malignant otitis externa) in the affected ear(s).
- Known or suspected ear infection of yeast, fungal or mycobacterial origin in the affected ear(s).
- Prior otologic surgery within 6 months of study entry in the affected ear(s).
- Known or suspected allergy or hypersensitivity to quinolones or other ingredients present in the medications to be used in the study.
- Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue their use during the study period.
- Other protocol-defined exclusion criteria may apply.
About this study
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).
Read the detailed description
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.
- Conditions
- Acute Otitis Externa
- Being tested
- AL-60371, 0.3% Otic Suspension, AL-60371 Vehicle
- Keywords
- Acute Otitis Externa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-60371, 0.3% Otic SuspensionDrug
AL-60371 VehicleOther
Inactive ingredients used as a placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| AL-60371 | Experimental | AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days Receives: Drug: AL-60371, 0.3% Otic Suspension |
| Vehicle | Placebo comparator | AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days Receives: Other: AL-60371 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 11
Secondary outcomes (2)
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.
Measured: 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.
Measured: Time to event, up to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Otitis ExternaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 768 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sally Scheib, Sr. Clinical Project Lead, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535599
- Sponsor's protocol ID
- C-10-018
- Status last verified
- Jun 2014
- First submitted
- 15 Feb 2012
- Last updated
- 8 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bentley C, Luckermann M, Dalhoff A, Vente A. Acute Otitis Externa-Antimicrobial Resistance in the US and Canada: Phase III Study Outcomes. Ann Otol Rhinol Laryngol. 2026 Oct 17:34894261496759. doi: 10.1177/00034894261496759. Online ahead of print.
PubMed 42892712Edmunds 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.
PubMed 42210509
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
- ClinicalTrials.gov ID
- NCT01535599
- Acronym / sponsor ID
- C-10-018
- Conditions
- Acute Otitis Externa
- Keywords
- Acute Otitis Externa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 768 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Feb 2012 (estimated)
- Results
- Posted 18 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL-60371 | Experimental | Drug: AL-60371, 0.3% Otic SuspensionAL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days |
| Vehicle | Placebo comparator | Other: AL-60371 VehicleAL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- At least 6 months of age.
- Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear.
- Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema.
- Agree to refrain from water immersion of the ears during the conduct of the entire study.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (8 listed)
- Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as reported by patient or parent/guardian.
- Presence of a tympanostomy tube or perforated tympanic membrane in the affected ear(s).
- Clinically diagnosed otic disease other than AOE (eg, malignant otitis externa) in the affected ear(s).
- Known or suspected ear infection of yeast, fungal or mycobacterial origin in the affected ear(s).
- Prior otologic surgery within 6 months of study entry in the affected ear(s).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL-60371, 0.3% Otic Suspension | Drug | AL-60371 |
| AL-60371 VehicleInactive ingredients used as a placebo comparator | Other | Vehicle |
Primary outcome
Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit
Time frame: 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.
2 secondary outcomes
Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit
Time frame: Day 11
Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary
Time frame: Time to event, up to Day 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42892712Bentley C, Luckermann M, Dalhoff A, Vente A. Acute Otitis Externa-Antimicrobial Resistance in the US and Canada: Phase III Study Outcomes. Ann Otol Rhinol Laryngol. 2026 Oct 17:34894261496759. doi: 10.1177/00034894261496759. Online ahead of print.
- Derived from this study: PubMed 42210509Edmunds 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sally Scheib, Sr. Clinical Project Lead study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AL-60371, 0.3% Otic Suspension in people with Acute Otitis Externa, run by Alcon Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit (time frame: Day 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01535599, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.