Phase 3
N=549
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Acute Otitis Externa
Bottom Line
View on ClinicalTrials.gov: NCT01535560 ↗Enrolled (actual)
549
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit — 68.7; 40.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AL-60371, 0.3% otic suspension (Drug); AL-60371 Vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit |
68.7; 40.0 | — |
| SECONDARY Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit |
66.0; 11.5 | — |
| SECONDARY Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary |
3.0; 6.5 | — |
Summary
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).
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.
Data sourced from ClinicalTrials.gov (NCT01535560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.