Trial Outcomes & Findings for OTO-201 for the Treatment of Otitis Externa (NCT NCT02511561)

Last Updated: 2020-10-19

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

Up to 1 month

Results posted on

2020-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	6 mg OTO-201 6 mg ciprofloxacin: single administration	12 mg OTO-201 12 mg ciprofloxacin: single administration	24 mg OTO-201 24 mg ciprofloxacin: single administration
Overall Study STARTED	25	25	25
Overall Study COMPLETED	25	25	25
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OTO-201 for the Treatment of Otitis Externa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	6 mg OTO-201 n=25 Participants 6 mg ciprofloxacin: single administration	12 mg OTO-201 n=25 Participants 12 mg ciprofloxacin: single administration	24 mg OTO-201 n=25 Participants 24 mg ciprofloxacin: single administration	Total n=75 Participants Total of all reporting groups
Age, Continuous	38.8 years STANDARD_DEVIATION 21.95 • n=5 Participants	30.0 years STANDARD_DEVIATION 20.12 • n=7 Participants	43.0 years STANDARD_DEVIATION 23.74 • n=5 Participants	37.3 years STANDARD_DEVIATION 22.37 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	35 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	40 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	19 Participants n=7 Participants	23 Participants n=5 Participants	63 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	21 Participants n=7 Participants	18 Participants n=5 Participants	61 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	25 participants n=5 Participants	75 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 1 month

Population: Safety analysis set: All subjects who received study drug.

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)

Outcome measures

Outcome measures
Measure	6 mg OTO-201 n=25 Participants 6 mg ciprofloxacin: single administration	12 mg OTO-201 n=25 Participants 12 mg ciprofloxacin: single administration	24 mg OTO-201 n=25 Participants 24 mg ciprofloxacin: single administration
Otoscopic Examination: Tympanic Membrane	6 Participants	8 Participants	8 Participants

PRIMARY outcome

Timeframe: Up to 1 month

Population: Safety analysis set: All subjects that received drug

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)

Outcome measures

Outcome measures
Measure	6 mg OTO-201 n=25 Participants 6 mg ciprofloxacin: single administration	12 mg OTO-201 n=25 Participants 12 mg ciprofloxacin: single administration	24 mg OTO-201 n=25 Participants 24 mg ciprofloxacin: single administration
Otoscopic Examination: Middle Ear	8 Participants	7 Participants	8 Participants

PRIMARY outcome

Timeframe: Day1

Population: Safety analysis set: All subjects who receieved study drug

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".

Outcome measures

Outcome measures
Measure	6 mg OTO-201 n=25 Participants 6 mg ciprofloxacin: single administration	12 mg OTO-201 n=25 Participants 12 mg ciprofloxacin: single administration	24 mg OTO-201 n=25 Participants 24 mg ciprofloxacin: single administration
Feasibility of Administration	24 Participants	25 Participants	25 Participants

PRIMARY outcome

Timeframe: up to 1 month

Population: Safety analysis set: All subjects that received study drug

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

Outcome measures

Outcome measures
Measure	6 mg OTO-201 n=25 Participants 6 mg ciprofloxacin: single administration	12 mg OTO-201 n=25 Participants 12 mg ciprofloxacin: single administration	24 mg OTO-201 n=25 Participants 24 mg ciprofloxacin: single administration
Overall Adverse Events Number of subjects with at least 1 adverse event	8 Participants	9 Participants	13 Participants
Overall Adverse Events Number of subjects with no adverse events	17 Participants	16 Participants	12 Participants

SECONDARY outcome

Timeframe: Day 15 (two weeks from dosing)

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

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

Outcome measures

Outcome measures
Measure	6 mg OTO-201 n=25 Participants 6 mg ciprofloxacin: single administration	12 mg OTO-201 n=25 Participants 12 mg ciprofloxacin: single administration	24 mg OTO-201 n=25 Participants 24 mg ciprofloxacin: single administration
Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)	14 Participants	19 Participants	16 Participants

SECONDARY outcome

Timeframe: Day 15 (2 weeks from dosing)

Population: 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.

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

Outcome measures

Outcome measures
Measure	6 mg OTO-201 n=24 Participants 6 mg ciprofloxacin: single administration	12 mg OTO-201 n=22 Participants 12 mg ciprofloxacin: single administration	24 mg OTO-201 n=25 Participants 24 mg ciprofloxacin: single administration
Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)	13 Participants	19 Participants	15 Participants

Adverse Events

6 mg OTO-201

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

12 mg OTO-201

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

24 mg OTO-201

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	6 mg OTO-201 n=25 participants at risk 6 mg ciprofloxacin: single administration	12 mg OTO-201 n=25 participants at risk 12 mg ciprofloxacin: single administration	24 mg OTO-201 n=25 participants at risk 24 mg ciprofloxacin: single administration
Infections and infestations Otitis externa	8.0% 2/25 • Adverse events were reported during dosing and up to 1 month following dosing.	12.0% 3/25 • Adverse events were reported during dosing and up to 1 month following dosing.	16.0% 4/25 • Adverse events were reported during dosing and up to 1 month following dosing.
Ear and labyrinth disorders Ear pain	0.00% 0/25 • Adverse events were reported during dosing and up to 1 month following dosing.	4.0% 1/25 • Adverse events were reported during dosing and up to 1 month following dosing.	12.0% 3/25 • Adverse events were reported during dosing and up to 1 month following dosing.
Ear and labyrinth disorders Hypacusis	0.00% 0/25 • Adverse events were reported during dosing and up to 1 month following dosing.	4.0% 1/25 • Adverse events were reported during dosing and up to 1 month following dosing.	12.0% 3/25 • Adverse events were reported during dosing and up to 1 month following dosing.

Additional Information

Medical Information Call Center

Otonomy

Phone: 1-800-826-6411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication subject to Sponsor consent.
Publication restrictions are in place

Restriction type: OTHER