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

Proof of Concept of Single Application of AL-60371/AL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)

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.

Study Overview

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

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AL-60371/AL-817; 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
Active Comparator: CIPRODEX; 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; CIPRODEX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With Microbiological Success at the Day 8 Visit	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.	Day 8
Median Time (in Days) to Cessation of Otorrhea	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.	Time to event, up to Day 8

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Manager, GCRA, Pharma, Alcon Research

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: anti-infective; tympanostomy tubes; AOMT; Otorrhea
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Dexamethasone; Ciprofloxacin
• Other Study ID Numbers: C-13-026