Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Primary Purpose
Acute Otitis Externa
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
AL-60371, 0.3% Otic Suspension
AL-60371 Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Acute Otitis Externa focused on measuring Acute Otitis Externa
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AL-60371
Vehicle
Arm Description
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01535599
Brief Title
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Official Title
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Externa
Keywords
Acute Otitis Externa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
768 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-60371
Arm Type
Experimental
Arm Description
AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
AL-60371, 0.3% Otic Suspension
Intervention Type
Other
Intervention Name(s)
AL-60371 Vehicle
Intervention Description
Inactive ingredients used as a placebo comparator
Primary Outcome Measure Information:
Title
Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit
Description
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
Secondary Outcome Measure Information:
Title
Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit
Description
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
Title
Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sally Scheib, Sr. Clinical Project Lead
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
We'll reach out to this number within 24 hrs