OTO-201 for the Treatment of Otitis Externa

• Sponsor: Otonomy, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02511561
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Duration (Months): 4
• Patients Per Site Per Month: 18.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Otitis Externa	Drug: OTO-201 (ciprofloxacin)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. Otoscopic Examination: Tympanic Membrane [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)

2. Otoscopic Examination: Middle Ear [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)

3. Feasibility of Administration [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".

4. Overall Adverse Events [up to 1 month]

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

Secondary Outcome Measures

1. Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set) [Day 15 (two weeks from dosing)]

   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

2. Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set) [Day 15 (2 weeks from dosing)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Email Otonomy Central Contact for Trial Locations	San Diego	California	United States	92121

Sponsors and Collaborators

• Otonomy, Inc.

Investigators

• Study Chair: Carl LeBel, PhD, Otonomy, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otonomy, Inc.
• ClinicalTrials.gov Identifier: NCT02511561
• Other Study ID Numbers: 201-201506
• First Posted: Jul 30, 2015
• Last Update Posted: Oct 19, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Otonomy, Inc.: Otitis externa; Swimmer's ear; Ear infection
• Additional relevant MeSH terms: Otitis; Otitis Externa; Ciprofloxacin

Study Results

Participant Flow

Arm/Group Title	6 mg OTO-201	12 mg OTO-201	24 mg OTO-201
Arm/Group Description	6 mg ciprofloxacin: single administration	12 mg ciprofloxacin: single administration	24 mg ciprofloxacin: single administration
Period Title: Overall Study
STARTED	25	25	25
COMPLETED	25	25	25
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	6 mg OTO-201	12 mg OTO-201	24 mg OTO-201	Total
Arm/Group Description	6 mg ciprofloxacin: single administration	12 mg ciprofloxacin: single administration	24 mg ciprofloxacin: single administration	Total of all reporting groups
Overall Participants	25	25	25	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.8 (21.95)	30.0 (20.12)	43.0 (23.74)	37.3 (22.37)
Sex: Female, Male (Count of Participants)
Female	12 48%	11 44%	12 48%	35 46.7%
Male	13 52%	14 56%	13 52%	40 53.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 16%	6 24%	2 8%	12 16%
Not Hispanic or Latino	21 84%	19 76%	23 92%	63 84%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	2 8%	2 2.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	3 12%	3 12%	5 20%	11 14.7%
White	22 88%	21 84%	18 72%	61 81.3%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 4%	0 0%	1 1.3%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	25 100%	75 100%

Outcome Measures

1. Primary Outcome

Title	Otoscopic Examination: Tympanic Membrane
Description	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

Outcome Measure Data

Analysis Population Description

Safety analysis set: All subjects who received study drug.

Arm/Group Title	6 mg OTO-201	12 mg OTO-201	24 mg OTO-201
Arm/Group Description	6 mg ciprofloxacin: single administration	12 mg ciprofloxacin: single administration	24 mg ciprofloxacin: single administration
Measure Participants	25	25	25
Count of Participants [Participants]	6 24%	8 32%	8 32%

2. Primary Outcome

Title	Otoscopic Examination: Middle Ear
Description	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

Outcome Measure Data

Analysis Population Description

Safety analysis set: All subjects that received drug

Arm/Group Title	6 mg OTO-201	12 mg OTO-201	24 mg OTO-201
Arm/Group Description	6 mg ciprofloxacin: single administration	12 mg ciprofloxacin: single administration	24 mg ciprofloxacin: single administration
Measure Participants	25	25	25
Count of Participants [Participants]	8 32%	7 28%	8 32%

3. Primary Outcome

Title	Feasibility of Administration
Description	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

Outcome Measure Data

Analysis Population Description

Safety analysis set: All subjects who receieved study drug

Arm/Group Title	6 mg OTO-201	12 mg OTO-201	24 mg OTO-201
Arm/Group Description	6 mg ciprofloxacin: single administration	12 mg ciprofloxacin: single administration	24 mg ciprofloxacin: single administration
Measure Participants	25	25	25
Count of Participants [Participants]	24 96%	25 100%	25 100%

4. Primary Outcome

Title	Overall Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

Safety analysis set: All subjects that received study drug

Arm/Group Title	6 mg OTO-201	12 mg OTO-201	24 mg OTO-201
Arm/Group Description	6 mg ciprofloxacin: single administration	12 ciprofloxacin: single administration	24 mg ciprofloxacin: single administration
Measure Participants	25	25	25
Number of subjects with at least 1 adverse event	8 32%	9 36%	13 52%
Number of subjects with no adverse events	17 68%	16 64%	12 48%

5. Secondary Outcome

Title	Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)
Description	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)

Outcome Measure Data

Analysis Population Description

Intent-to-treat analysis set: All subjects who were randomized and were used for assessments of clinical activity

Arm/Group Title	6 mg OTO-201	12 mg OTO-201	24 mg OTO-201
Arm/Group Description	6 mg ciprofloxacin: single administration	12 ciprofloxacin: single administration	24 mg ciprofloxacin: single administration
Measure Participants	25	25	25
Count of Participants [Participants]	14 56%	19 76%	16 64%

6. Secondary Outcome

Title	Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)
Description	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)

Outcome Measure Data

Analysis Population Description

Per-protocol Analysis Set defined as all subjects in the ITT analysis set who received study drug, completed Visit 4 (Day 15), and did not have a major protocol deviation.

Arm/Group Title	6 mg OTO-201	12 mg OTO-201	24 mg OTO-201
Arm/Group Description	6 mg ciprofloxacin: single administration	12 mg ciprofloxacin: single administration	24 mg ciprofloxacin: single administration
Measure Participants	24	22	25
Count of Participants [Participants]	13 52%	19 76%	15 60%

Adverse Events

Time Frame	Adverse events were reported during dosing and up to 1 month following dosing.
Arm/Group Title	6 mg OTO-201		12 mg OTO-201		24 mg OTO-201
Arm/Group Description	6 mg ciprofloxacin: single administration		12 mg ciprofloxacin: single administration		24 mg ciprofloxacin: single administration
All Cause Mortality
	6 mg OTO-201		12 mg OTO-201		24 mg OTO-201
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)
Serious Adverse Events
	6 mg OTO-201		12 mg OTO-201		24 mg OTO-201
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	6 mg OTO-201		12 mg OTO-201		24 mg OTO-201
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/25 (8%)		5/25 (20%)		10/25 (40%)
Ear and labyrinth disorders
Ear pain	0/25 (0%)		1/25 (4%)		3/25 (12%)
Hypacusis	0/25 (0%)		1/25 (4%)		3/25 (12%)
Infections and infestations
Otitis externa	2/25 (8%)		3/25 (12%)		4/25 (16%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publication subject to Sponsor consent.