Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes

NCT01908803 | Terminated Phase 2 Results

• 1 other identifier: C-13-026
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.

Conditions

Acute Otitis Media

Keywords

AOMT; tympanostomy tubes; Otorrhea; anti-infective

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit

  A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.

  Day 3 post-treatment up to Day 8 or Early Exit

Secondary Outcomes (2)

• Proportion of Subjects With Microbiological Success at the Day 8 Visit

  Day 8

• Median Time (in Days) to Cessation of Otorrhea

  Time to event, up to Day 8

Study Arms (2)

AL-60371/AL-817

EXPERIMENTAL

AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)

Drug: AL-60371/AL-817 otic suspension

CIPRODEX

ACTIVE COMPARATOR

Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days

Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension

Interventions

AL-60371/AL-817 otic suspension DRUG

AL-60371/AL-817

Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension DRUG

CIPRODEX®

CIPRODEX

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;
• Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;
• Presence of patent tympanostomy tubes;
• Refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
• Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;

You may not qualify if:

• NOT otorrhea-free for at least seven days following tympanostomy tube surgery;
• Menarcheal females;
• Previous otologic surgery, except tympanic membrane, within one year of study entry;
• History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
• Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;
• Diabetic (controlled or uncontrolled);
• Use of prohibited medications;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Otitis Media

Interventions

Ciprofloxacin; Dexamethasone

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Sr Clinical Project Lead, GCRA, Pharma
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, GCRA, Pharma

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 6, 2017
• Results First Posted: September 24, 2015

Record last verified: 2017-11