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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-25

Study Completion Date

2016-06-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Otitis Media With Effusion in Children Otitis Media Recurrent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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EXE844 for 7 Days + Tubes

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

Group Type EXPERIMENTAL

EXE844 Sterile Otic Suspension, 0.3%

Intervention Type DRUG

Tympanostomy Tube Insertion

Intervention Type PROCEDURE

Surgical procedure for treating pediatric cases of recurrent or chronic otitis media

EXE844 for 3 Days + Tubes

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

Group Type EXPERIMENTAL

EXE844 Sterile Otic Suspension, 0.3%

Intervention Type DRUG

Tympanostomy Tube Insertion

Intervention Type PROCEDURE

Surgical procedure for treating pediatric cases of recurrent or chronic otitis media

Tubes Only

Bilateral myringotomy and tympanostomy tube insertion

Group Type ACTIVE_COMPARATOR

Tympanostomy Tube Insertion

Intervention Type PROCEDURE

Surgical procedure for treating pediatric cases of recurrent or chronic otitis media

Interventions

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EXE844 Sterile Otic Suspension, 0.3%

Intervention Type DRUG

Tympanostomy Tube Insertion

Surgical procedure for treating pediatric cases of recurrent or chronic otitis media

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No