Acute Otitis ExternaPhase 3NCT00750633
A Phase III Study of an Otic Formulation in Acute Otitis Externa
A Phase 3 study testing Moxidex otic solution, Moxifloxacin otic solution and Dexamethasone phosphate otic solution in people with Acute Otitis Externa, run by Alcon Research.
Trial summary
The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE). Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Acute Otitis Externa
- What is being tested?
- Moxidex otic solution, Moxifloxacin otic solution and Dexamethasone phosphate otic solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Jan 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin
- A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Duration of pretherapy signs or symptoms of AOE greater than four (4) weeks
- Presence of a tympanostomy tube or perforated tympanic membrane in the treated ear(s). Patients with a history of tympanic membrane perforation should not be enrolled unless the absence of a current perforation can be confirmed at Visit 1 prior to enrollment
- Clinically diagnosed chronic suppurative otitis media, acute otitis media, acute otorrhea in patients with tympanostomy tubes, or malignant otitis externa
- Known or suspected ear infection of fungal or mycobacterial origin
- Prior otologic surgery within 6 months of study entry
- Seborrheic dermatitis or other skin conditions of the external auditory canal
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- Current or prior history of an immunosuppressive disorder (e.g., HIV positive) or current immunosuppressive therapy (e.g., cancer chemotherapy) or known acute or chronic renal disorders or active hepatitis
- Diabetic patients (controlled or uncontrolled) based upon assessment by Investigator
- Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study [e.g., cleft palate (including repairs), Downs Syndrome, and cranial facial reconstruction]
- Any current known or suspected infection (other than AOE) requiring systemic antimicrobial therapy
- Use of prohibited medications or inadequate washout of any medication listed in protocol
- Concomitant use of topical or oral analgesics (i.e., NSAIDs and aspirin products) which may have anti inflammatory effects. Patients on low dose aspirin therapy (81 mg per day) at the time of enrollment may be enrolled and continue the low dose aspirin during the study. Use of acetaminophen ("Tylenol") is permitted during the trial
- Other protocol-defined exclusion criteria may apply
About this study
The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).
- Conditions
- Acute Otitis Externa
- Being tested
- Moxidex otic solution, Moxifloxacin otic solution, Dexamethasone phosphate otic solution, Tympanostomy tubes
- Keywords
- swimmer's ear, ear drops, ear infection, ear pain, ear inflammation
- Medical subject headings
- Otitis Externa, Otitis, Earache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxidex otic solutionDrug
4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
Moxifloxacin otic solutionDrug
4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
Dexamethasone phosphate otic solutionDrug
4 drops in the infected ear(s) twice daily (morning and evening) for 7 days
Tympanostomy tubesDevice
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media with effusion in children
| Study group | Role | What they receive |
|---|---|---|
| Moxidex | Experimental | Moxidex otic solution Receives: Drug: Moxidex otic solution; Device: Tympanostomy tubes |
| Moxifloxacin | Active comparator | Moxifloxacin otic solution Receives: Drug: Moxifloxacin otic solution; Device: Tympanostomy tubes |
| Dexamethasone | Active comparator | Dexamethasone phosphate otic solution Receives: Drug: Dexamethasone phosphate otic solution; Device: Tympanostomy tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure
Measured: Day 3
Clinical Cure
Measured: Day 12
Secondary outcomes (1)
Microbiological Success
Measured: Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis ExternaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 990 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Contact Alcon Call Center, Study director, 1-888-451-3937
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750633
- Sponsor's protocol ID
- C-07-13
- Status last verified
- Nov 2012
- First submitted
- 8 Sep 2008
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of an Otic Formulation in Acute Otitis Externa
- ClinicalTrials.gov ID
- NCT00750633
- Acronym / sponsor ID
- C-07-13
- Conditions
- Acute Otitis Externa
- Keywords
- swimmer's ear, ear drops, ear infection, ear pain, ear inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 990 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Not posted in the source record
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 determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moxidex | Experimental | Drug: Moxidex otic solution, Device: Tympanostomy tubesMoxidex otic solution |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin otic solution, Device: Tympanostomy tubesMoxifloxacin otic solution |
| Dexamethasone | Active comparator | Drug: Dexamethasone phosphate otic solution, Device: Tympanostomy tubesDexamethasone phosphate otic solution |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin
- A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema
- Other protocol-defined inclusion criteria may apply
Key exclusion criteria (13 listed)
- Duration of pretherapy signs or symptoms of AOE greater than four (4) weeks
- Presence of a tympanostomy tube or perforated tympanic membrane in the treated ear(s). Patients with a history of tympanic membrane perforation should not be enrolled unless the absence of a current perforation can be confirmed at Visit 1 prior to enrollment
- Clinically diagnosed chronic suppurative otitis media, acute otitis media, acute otorrhea in patients with tympanostomy tubes, or malignant otitis externa
- Known or suspected ear infection of fungal or mycobacterial origin
- Prior otologic surgery within 6 months of study entry
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 |
|---|---|---|
| Moxidex otic solution4 drops in the infected ear(s) twice daily (morning and evening) for 7 days | Drug | Moxidex |
| Moxifloxacin otic solution4 drops in the infected ear(s) twice daily (morning and evening) for 7 days | Drug | Moxifloxacin |
| Dexamethasone phosphate otic solution4 drops in the infected ear(s) twice daily (morning and evening) for 7 days | Drug | Dexamethasone |
| Tympanostomy tubesTubes surgically inserted through the ear drum for the treatment of recurrent otitis media with effusion in children | Device | Dexamethasone, Moxidex, Moxifloxacin |
Primary outcome
Clinical Cure
Time frame: Day 3
Clinical Cure
Time frame: Day 12
1 secondary outcome
Microbiological Success
Time frame: Day 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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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.
Contact Alcon Call Center study director
1-888-451-3937
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxidex otic solution, Moxifloxacin otic solution and Dexamethasone phosphate otic solution in people with Acute Otitis Externa, 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 3 inclusion and 13 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 3 Dec 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Cure (time frame: Day 3). The study lists 2 primary outcomes in all. 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 3 Dec 2012.