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CompletedNCT02511561Updated Oct 19, 2020Results posted

OTO-201 for the Treatment of Otitis Externa

A Phase 2 interventional study of OTO-201 (ciprofloxacin) in Otitis Externa, sponsored by Otonomy, Inc.. Completed at 1 site in United States. Open to participants aged 6 Months to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Otonomy, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
6 Months to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Otitis Externa

Keywords

  • Otitis externa
  • Swimmer's ear
  • Ear infection
03

In context

Otitis Externa

22 studies on the registry are indexed under Otitis Externa; 1 is open to participants now.

This study's enrollment of 75 is below the median of 100 across 20 interventional studies indexed under Otitis Externa.

Browse Otitis Externa studies →

Lead sponsor

Otonomy, Inc. is the lead sponsor of 22 studies on the registry; none are open to participants now.

Browse Otonomy, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria includes, but is not limited to:

  • 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

Exclusion Criteria includes, but is not limited to:

  • Subject has tympanic membrane perforation
  • Subject has a history of known immunodeficiency disease
  • Subject has fungal otitis externa, based on clinical signs
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    0.1 mL OTO-201

    Ciprofloxacin

    Drug: OTO-201 (ciprofloxacin)

  • Experimental
    0.2 mL OTO-201

    Ciprofloxacin

    Drug: OTO-201 (ciprofloxacin)

  • Experimental
    0.4 mL OTO-201

    Ciprofloxacin

    Drug: OTO-201 (ciprofloxacin)

Interventions

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Up to 1 month

  2. 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)

    Time frame: Up to 1 month

  3. 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".

    Time frame: Day1

  4. Overall Adverse Events

    Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing

    Time frame: up to 1 month

Secondary outcomes

  1. 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

    Time frame: Day 15 (two weeks from dosing)

  2. 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

    Time frame: Day 15 (2 weeks from dosing)

07

Results

Posted Sep 22, 2020

Participant flow

Participant flow — Overall Study
Milestone6 mg OTO-20112 mg OTO-20124 mg OTO-201
Started252525
Completed252525
Not completed000

Outcome measures

PrimaryOtoscopic 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)

Time frame:
Up to 1 month
Reported as:
Count of participants · Participants
Otoscopic Examination: Tympanic Membrane
Participants6 mg OTO-20112 mg OTO-20124 mg OTO-201
Otoscopic Examination: Tympanic Membrane688
PrimaryOtoscopic 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)

Time frame:
Up to 1 month
Reported as:
Count of participants · Participants
Otoscopic Examination: Middle Ear
Participants6 mg OTO-20112 mg OTO-20124 mg OTO-201
Otoscopic Examination: Middle Ear878
PrimaryFeasibility 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".

Time frame:
Day1
Reported as:
Count of participants · Participants
Feasibility of Administration
Participants6 mg OTO-20112 mg OTO-20124 mg OTO-201
Feasibility of Administration242525
PrimaryOverall Adverse Events

Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing

Time frame:
up to 1 month
Reported as:
Count of participants · Participants
Overall Adverse Events
Participants6 mg OTO-20112 mg OTO-20124 mg OTO-201
Number of subjects with at least 1 adverse event8913
Number of subjects with no adverse events171612
SecondaryNumber 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

Time frame:
Day 15 (two weeks from dosing)
Reported as:
Count of participants · Participants
Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)
Participants6 mg OTO-20112 mg OTO-20124 mg OTO-201
Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)141916
SecondaryNumber 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

Time frame:
Day 15 (2 weeks from dosing)
Reported as:
Count of participants · Participants
Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)
Participants6 mg OTO-20112 mg OTO-20124 mg OTO-201
Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)131915

Adverse events

Collected over Adverse events were reported during dosing and up to 1 month following dosing.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
6 mg OTO-2010/25 (0%)0/25 (0%)2/25 (8%)
12 mg OTO-2010/25 (0%)0/25 (0%)5/25 (20%)
24 mg OTO-2010/25 (0%)0/25 (0%)10/25 (40%)
Most frequent other events
Most frequent other events
Event6 mg OTO-20112 mg OTO-20124 mg OTO-201
Otitis externaInfections and infestations2/253/254/25
Ear painEar and labyrinth disorders0/251/253/25
HypacusisEar and labyrinth disorders0/251/253/25

Baseline characteristics

Age, Continuous
Age, Continuous(years)6 mg OTO-20112 mg OTO-20124 mg OTO-201Total
Mean38.8 ± 21.9530.0 ± 20.1243.0 ± 23.7437.3 ± 22.37
Sex: Female, Male
Sex: Female, Male(Participants)6 mg OTO-20112 mg OTO-20124 mg OTO-201Total
Female12111235
Male13141340
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)6 mg OTO-20112 mg OTO-20124 mg OTO-201Total
Hispanic or Latino46212
Not Hispanic or Latino21192363
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)6 mg OTO-20112 mg OTO-20124 mg OTO-201Total
American Indian or Alaska Native0000
Asian0022
Native Hawaiian or Other Pacific Islander0000
Black or African American33511
White22211861
More than one race0000
Unknown or Not Reported0101
Region of Enrollment
Region of Enrollment(participants)6 mg OTO-20112 mg OTO-20124 mg OTO-201Total
United States25252575
08

Study locations

1 site
  • Email Otonomy Central Contact for Trial Locations
    San Diego, California 92121, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02511561
Lead sponsor
Otonomy, Inc.
Responsible party
Sponsor
First posted
Jul 30, 2015
Start date
Jul 2015
Primary completion
Nov 2015
Completion
Nov 2015
Results posted
Sep 22, 2020
Last update
Oct 19, 2020

Study contacts

Carl LeBel, PhD
study chair · Otonomy, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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