Otitis ExternaPhase 2NCT02511561
OTO-201 for the Treatment of Otitis Externa
A Phase 2 study testing OTO-201 (ciprofloxacin) in people with Otitis Externa, run by Otonomy, Inc. at 1 site in United States.
Trial summary
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa. Read more about this study
- Who is it for?
- Ages 6 months to 80 years
- Conditions the study is for
- Otitis Externa
- What is being tested?
- OTO-201 (ciprofloxacin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Nov 2015
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is a male or female aged 6 months to 80 years, inclusive
- Subject has a clinical diagnosis of unilateral otitis externa
- Subject or subject's caregiver is willing to comply with the protocol and attend all study visits
Who cannot join
- Subject has tympanic membrane perforation
- Subject has a history of known immunodeficiency disease
- Subject has fungal otitis externa, based on clinical signs
Trial locations and contacts
1 site in 1 country.
United States1 site
Email Otonomy Central Contact for Trial Locations
San Diego, California, 92121
About this study
Official title: A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.
- Conditions
- Otitis Externa
- Being tested
- OTO-201 (ciprofloxacin)
- Keywords
- Otitis externa, Swimmer's ear, Ear infection
- Medical subject headings
- Otitis Externa, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTO-201 (ciprofloxacin)Drug
| Study group | Role | What they receive |
|---|---|---|
| 0.1 mL OTO-201 | Experimental | Ciprofloxacin Receives: Drug: OTO-201 (ciprofloxacin) |
| 0.2 mL OTO-201 | Experimental | Ciprofloxacin Receives: Drug: OTO-201 (ciprofloxacin) |
| 0.4 mL OTO-201 | Experimental | Ciprofloxacin Receives: Drug: OTO-201 (ciprofloxacin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Otoscopic Examination: Tympanic Membrane
Number of subjects with a tympanic membrane that was rated as "Not able to Visualize" or "Abnormal" at Baseline that was rated as "Normal" at Day 29 (final study day)
Measured: Up to 1 month
Otoscopic Examination: Middle Ear
Number of subjects with a middle ear that was rated as "Not Able to Visualize" or "Abnormal" at Baseline that had a middle ear rated as "Normal" at Day 29 (final study visit)
Measured: Up to 1 month
Feasibility of Administration
Ease of administering OTO-201 to the external ear canal. Number of subjects that investigators rated ease of administration as either "easy" or "very easy".
Measured: Day1
Overall Adverse Events
Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing
Measured: up to 1 month
Secondary outcomes (2)
Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:
None = 0 Mild = 1 Moderate = 2 Severe = 3
Measured: Day 15 (two weeks from dosing)
Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:
None = 0 Mild = 1 Moderate = 2 Severe = 3
Measured: Day 15 (2 weeks from dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionNov 2015
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 ExternaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otonomy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl LeBel, PhD, Study chair, Otonomy, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511561
- Sponsor's protocol ID
- 201-201506
- Status last verified
- Sep 2020
- First submitted
- 28 Jul 2015
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa
- ClinicalTrials.gov ID
- NCT02511561
- Acronym / sponsor ID
- 201-201506
- Conditions
- Otitis Externa
- Keywords
- Otitis externa, Swimmer's ear, Ear infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Otonomy, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Posted 22 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.1 mL OTO-201 | Experimental | Drug: OTO-201 (ciprofloxacin)Ciprofloxacin |
| 0.2 mL OTO-201 | Experimental | Drug: OTO-201 (ciprofloxacin)Ciprofloxacin |
| 0.4 mL OTO-201 | Experimental | Drug: OTO-201 (ciprofloxacin)Ciprofloxacin |
Who may qualify
- Ages
- 6 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is a male or female aged 6 months to 80 years, inclusive
- Subject has a clinical diagnosis of unilateral otitis externa
- Subject or subject's caregiver is willing to comply with the protocol and attend all study visits
Key exclusion criteria (3 listed)
- Subject has tympanic membrane perforation
- Subject has a history of known immunodeficiency disease
- Subject has fungal otitis externa, based on clinical signs
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 |
|---|---|---|
| OTO-201 (ciprofloxacin) | Drug | 0.1 mL OTO-201, 0.2 mL OTO-201, 0.4 mL OTO-201 |
Primary outcome
Otoscopic Examination: Tympanic Membrane
Time frame: Up to 1 month
Number of subjects with a tympanic membrane that was rated as "Not able to Visualize" or "Abnormal" at Baseline that was rated as "Normal" at Day 29 (final study day)
Otoscopic Examination: Middle Ear
Time frame: Up to 1 month
Number of subjects with a middle ear that was rated as "Not Able to Visualize" or "Abnormal" at Baseline that had a middle ear rated as "Normal" at Day 29 (final study visit)
Feasibility of Administration
Time frame: Day1
Ease of administering OTO-201 to the external ear canal. Number of subjects that investigators rated ease of administration as either "easy" or "very easy".
Overall Adverse Events
Time frame: up to 1 month
Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing
2 secondary outcomes
Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)
Time frame: Day 15 (two weeks from dosing)
Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)
Time frame: Day 15 (2 weeks from dosing)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- 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.
Carl LeBel, PhD study chair
Otonomy, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OTO-201 (ciprofloxacin) in people with Otitis Externa, run by Otonomy, Inc. at 1 site in United States.
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 3 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 22 Sep 2020). 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?
Otoscopic Examination: Tympanic Membrane (time frame: Up to 1 month). The study lists 4 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 19 Oct 2020.