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

NCT02432105 | Completed Phase 3 Results

• 1 other identifier: EXE844b-C001
• Study Type: interventional
• Target: 470
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Otitis Media With Effusion in Children; Otitis Media Recurrent

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Sustained Clinical Cure at Day 8

  A sustained clinical cure was attained if otorrhea was absent in the study ear at Day 8 (EOT) per the Investigator assessment and continued to be absent through the end of the study. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).

  Day 8

Secondary Outcomes (2)

• Percentage of Subjects With Microbiological Success at Day 14

  Day 14

• Time to Cessation of Otorrhea

  Up to Day 14

Study Arms (3)

EXE844 for 7 Days + Tubes

EXPERIMENTAL

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

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

EXE844 for 3 Days + Tubes

EXPERIMENTAL

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

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

Tubes Only

ACTIVE COMPARATOR

Bilateral myringotomy and tympanostomy tube insertion

Procedure: Tympanostomy Tube Insertion

Interventions

EXE844 Sterile Otic Suspension, 0.3% DRUG

EXE844 for 3 Days + Tubes; EXE844 for 7 Days + Tubes

Tympanostomy Tube Insertion PROCEDURE

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

EXE844 for 3 Days + Tubes; EXE844 for 7 Days + Tubes; Tubes Only

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Interventions

Middle Ear Ventilation

Intervention Hierarchy (Ancestors)

Ostomy; Surgical Procedures, Operative; Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures

Results Point of Contact

• Title: Clinical Scientific Director, GCRA - Global Clinical Development
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, Ophtha, GCRA

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 1, 2015
• Study Start: June 25, 2015
• Primary Completion: June 15, 2016
• Study Completion: June 15, 2016
• Last Updated: July 2, 2018
• Results First Posted: July 12, 2017

Record last verified: 2017-06