Otitis Media With Effusion in ChildrenPhase 3NCT02432105
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)
A Phase 3 study testing EXE844 Sterile Otic Suspension, 0.3% and Tympanostomy Tube Insertion in people with Otitis Media With Effusion in Children and Otitis Media Recurrent, run by Alcon Research.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Otitis Media With Effusion in Children, Otitis Media Recurrent
- What is being tested?
- EXE844 Sterile Otic Suspension, 0.3% and Tympanostomy Tube Insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2015to 15 Jun 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of Tympanostomy Tube Insertion
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).
- Being tested
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXE844 Sterile Otic Suspension, 0.3%Drug
Tympanostomy Tube InsertionProcedure or surgery
Surgical procedure for treating pediatric cases of recurrent or chronic otitis media
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: EXE844 Sterile Otic Suspension, 0.3%; Procedure: Tympanostomy Tube Insertion |
| Tubes Only | Active comparator | Bilateral myringotomy and tympanostomy tube insertion Receives: Procedure: Tympanostomy Tube Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 8
Secondary outcomes (2)
Percentage of Subjects With Microbiological Success at Day 14
Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the Test-of-Cure (TOC) (Day 14) specimen. 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).
Measured: Day 14
Time to Cessation of Otorrhea
Time (in days) to the cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver via the BID diary. Participants were considered a treatment failure if, at any time during the course of 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).
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study start25 Jun 2015
- Primary completion15 Jun 2016
- Study completion15 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Otitis Media With Effusion in ChildrenStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Manager, Ophtha, GCRA, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432105
- Sponsor's protocol ID
- EXE844b-C001
- Status last verified
- Jun 2017
- First submitted
- 28 Apr 2015
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of Tympanostomy Tube Insertion
- ClinicalTrials.gov ID
- NCT02432105
- Acronym / sponsor ID
- EXE844b-C001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2015 (actual)
- Primary completion
- 15 Jun 2016 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Posted 12 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EXE844 for 7 Days + Tubes | Experimental | Drug: EXE844 Sterile Otic Suspension, 0.3%, Procedure: Tympanostomy Tube InsertionEXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion |
| EXE844 for 3 Days + Tubes | Experimental | Drug: EXE844 Sterile Otic Suspension, 0.3%, Procedure: Tympanostomy Tube InsertionEXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion |
| Tubes Only | Active comparator | Procedure: Tympanostomy Tube InsertionBilateral myringotomy and tympanostomy tube insertion |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXE844 Sterile Otic Suspension, 0.3% | Drug | EXE844 for 3 Days + Tubes, EXE844 for 7 Days + Tubes |
| Tympanostomy Tube InsertionSurgical procedure for treating pediatric cases of recurrent or chronic otitis media | Procedure or surgery | EXE844 for 3 Days + Tubes, EXE844 for 7 Days + Tubes, Tubes Only |
Primary outcome
Percentage of Subjects With Sustained Clinical Cure at Day 8
Time frame: 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).
2 secondary outcomes
Percentage of Subjects With Microbiological Success at Day 14
Time frame: Day 14
Time to Cessation of Otorrhea
Time frame: Up to Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Manager, Ophtha, GCRA study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EXE844 Sterile Otic Suspension, 0.3% and Tympanostomy Tube Insertion in people with Otitis Media With Effusion in Children and Otitis Media Recurrent, run by Alcon Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Sustained Clinical Cure at Day 8 (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.