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

Phase 2

Terminated

• Conditions: Acute Otitis Media
• Interventions: Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension; Drug: AL-60371/AL-817 otic suspension

• Registration Number: NCT01908803
• Lead Sponsor: Alcon Research

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.

Detailed Description

The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.

Study Timeline

• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-26
• Study Start: 2013-12
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-08-24
• Results First Submitted QC: 2015-08-24
• Results First Posted: 2015-09-24
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 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;
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• 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;
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIPRODEX	Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension	Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days
AL-60371/AL-817	AL-60371/AL-817 otic suspension	AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit	Day 3 post-treatment up to Day 8 or Early Exit	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects With Microbiological Success at the Day 8 Visit	Day 8	Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success.
Median Time (in Days) to Cessation of Otorrhea	Time to event, up to Day 8	Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries.