Trial Outcomes & Findings for Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration (NCT NCT02350998)

NCT ID: NCT02350998

Last Updated: 2020-10-19

Results Overview

Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 33 participants
• Primary outcome timeframe: Up to 1 month
• Results posted on: 2020-10-19

Participant Flow

Participant milestones

Measure	6 mg OTO-201 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
Overall Study STARTED	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration

Baseline characteristics by cohort

Measure	6 mg OTO-201 n=33 Participants 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
Age, Categorical <=18 years	33 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	2.92 years STANDARD_DEVIATION 2.465 • n=5 Participants
Age, Customized 6 months to 2 years	17 Participants n=5 Participants
Age, Customized >2 years	16 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 month

Population: Safety analysis set : consisted of all enrolled and treated subjects

Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29

Outcome measures

Measure	6mg OTO-201 n=66 ears 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
Otoscopic Examination: Auricle and Meatus	1 ears

PRIMARY outcome

Timeframe: up to 1 month

Population: Safety analysis set: all enrolled and treated subjects

Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29

Outcome measures

Measure	6mg OTO-201 n=66 ears 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
Otoscopic Examination: Tympanic Membrane	2 ears

PRIMARY outcome

Timeframe: Up to 1 month

Population: Safety analysis set: all enrolled and treated subjects

Subjects with at least one ear tube patent (i.e., not blocked) at Day 29

Outcome measures

Measure	6mg OTO-201 n=33 Participants 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
Otoscopic Examination: Tube Patency	32 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Safety analysis set consisted of all enrolled and treated subjects

Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either "easy" or "very easy"

Outcome measures

Measure	6mg OTO-201 n=33 Participants 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
Feasibility of Administration	29 Participants

Adverse Events

6 mg OTO-201

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	6 mg OTO-201 n=33 participants at risk 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
Infections and infestations Nasopharyngitis	21.2% 7/33 • Adverse events were reported during dosing and up to 1 month following dosing.
Infections and infestations Upper Respiratory Infection	9.1% 3/33 • Adverse events were reported during dosing and up to 1 month following dosing.
Ear and labyrinth disorders Ear Pain	12.1% 4/33 • Adverse events were reported during dosing and up to 1 month following dosing.
General disorders Pyrexia	12.1% 4/33 • Adverse events were reported during dosing and up to 1 month following dosing.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	6.1% 2/33 • Adverse events were reported during dosing and up to 1 month following dosing.

Additional Information

Medical Information Call Center

Otonomy, Inc.

Phone: 1-800-826-6411

Email: medinfo@otonomy.com

Results disclosure agreements

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

Restriction type: OTHER