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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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