Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa

NCT01535599 | Completed Phase 3 Results

• 1 other identifier: C-10-018
• Study Type: interventional
• Target: 768
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Acute Otitis Externa

Keywords

Acute Otitis Externa

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 11

Secondary Outcomes (2)

• Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit

  Day 11

• 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

Study Arms (2)

AL-60371

EXPERIMENTAL

AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days

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

Other: AL-60371 Vehicle

Interventions

AL-60371, 0.3% Otic Suspension DRUG

AL-60371

AL-60371 Vehicle OTHER

Inactive ingredients used as a placebo comparator

Vehicle

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Results Point of Contact

• Title: Sally Scheib, Sr. Clinical Project Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sally Scheib, Sr. Clinical Project Lead

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: February 20, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 8, 2014
• Results First Posted: June 18, 2014

Record last verified: 2014-06