Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)

Alcon

Status and phase: Completed; Phase 3

Conditions: Otitis Media Recurrent; Otitis Media With Effusion in Children

Treatments: Procedure: Tympanostomy Tube Insertion; Drug: EXE844 Sterile Otic Suspension, 0.3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02432105

EXE844b-C001

Details and patient eligibility

About

The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).

Enrollment: 470 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion.
• Suspected bacterial infection at time of surgery in at least 1 ear.
• Willing to 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.
• Legally Authorized Representative (LAR) must read and sign the informed consent.
• Parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol.
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Previous otologic or otologic-related surgery within the past 30 days or ongoing complications.
• Middle ear pathology in either ear other than otitis media.
• Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug.
• Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study based upon assessment by the Investigator.
• Known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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470 participants in 3 patient groups

EXE844 for 7 Days + Tubes

Experimental group

Description:

EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion

Treatment:

Procedure: Tympanostomy Tube Insertion

Drug: EXE844 Sterile Otic Suspension, 0.3%

EXE844 for 3 Days + Tubes

Experimental group

Description:

EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion

Treatment:

Procedure: Tympanostomy Tube Insertion

Drug: EXE844 Sterile Otic Suspension, 0.3%

Tubes Only

Active Comparator group

Description:

Bilateral myringotomy and tympanostomy tube insertion

Treatment:

Procedure: Tympanostomy Tube Insertion