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

Alcon

Status and phase: Terminated; Phase 2

Conditions: Acute Otitis Media

Treatments: Drug: AL-60371/AL-817 otic suspension; Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01908803

C-13-026

Details and patient eligibility

About

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.

Full description

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

Enrollment: 84 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

AL-60371/AL-817

Experimental group

Description:

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

Treatment:

Drug: AL-60371/AL-817 otic suspension

CIPRODEX

Active Comparator group

Description:

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

Treatment:

Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension