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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02350998
Recruitment Status : Completed
First Posted : January 30, 2015
Results First Posted : September 23, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bilateral Middle Ear Effusion
Intervention Drug: OTO-201
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 6 mg OTO-201
Hide Arm/Group Description 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
Period Title: Overall Study
Started 33
Completed 33
Not Completed 0
Arm/Group Title 6 mg OTO-201
Hide Arm/Group Description 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
33
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
2.92  (2.465)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
6 months to 2 years
17
  51.5%
>2 years
16
  48.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
11
  33.3%
Male
22
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Hispanic or Latino
2
   6.1%
Not Hispanic or Latino
31
  93.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   6.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  18.2%
White
23
  69.7%
More than one race
0
   0.0%
Unknown or Not Reported
2
   6.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
1.Primary Outcome
Title Otoscopic Examination: Auricle and Meatus
Hide Description 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
Time Frame Up to 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set : consisted of all enrolled and treated subjects
Arm/Group Title 6mg OTO-201
Hide Arm/Group Description:
6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
Overall Number of Participants Analyzed 33
Overall Number of Units Analyzed
Type of Units Analyzed: Ears
66
Count of Units
Unit of Measure: ears
1
   1.5%
2.Primary Outcome
Title Otoscopic Examination: Tympanic Membrane
Hide Description Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Time Frame up to 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: all enrolled and treated subjects
Arm/Group Title 6 mg OTO-201
Hide Arm/Group Description:
6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
Overall Number of Participants Analyzed 33
Overall Number of Units Analyzed
Type of Units Analyzed: Ears
66
Count of Units
Unit of Measure: ears
2
   3.0%
3.Primary Outcome
Title Otoscopic Examination: Tube Patency
Hide Description Subjects with at least one ear tube patent (i.e., not blocked) at Day 29
Time Frame Up to 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: all enrolled and treated subjects
Arm/Group Title 6 mg OTO-201
Hide Arm/Group Description:
6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
32
  97.0%
4.Secondary Outcome
Title Feasibility of Administration
Hide Description Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either "easy" or "very easy"
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set consisted of all enrolled and treated subjects
Arm/Group Title 6 mg OTO-201
Hide Arm/Group Description:
6 mg ciprofloxacin: single Trans-Tympanic Tube Admin istration
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
29
  87.9%
Time Frame Adverse events were reported during dosing and up to 1 month following dosing.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 6 mg OTO-201
Hide Arm/Group Description 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration
All-Cause Mortality
6 mg OTO-201
Affected / at Risk (%)
Total   0/33 (0.00%) 
Hide Serious Adverse Events
6 mg OTO-201
Affected / at Risk (%)
Total   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
6 mg OTO-201
Affected / at Risk (%)
Total   20/33 (60.61%) 
Ear and labyrinth disorders   
Ear Pain  1  4/33 (12.12%) 
General disorders   
Pyrexia  1  4/33 (12.12%) 
Infections and infestations   
Nasopharyngitis  1  7/33 (21.21%) 
Upper Respiratory Infection  1  3/33 (9.09%) 
Respiratory, thoracic and mediastinal disorders   
Nasal Congestion  1  2/33 (6.06%) 
1
Term from vocabulary, MedDRA (16.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication subject to Sponsor consent.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information Call Center
Organization: Otonomy, Inc.
Phone: 1-800-826-6411
EMail: medinfo@otonomy.com
Layout table for additonal information
Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT02350998    
Other Study ID Numbers: 201-201404
First Submitted: January 21, 2015
First Posted: January 30, 2015
Results First Submitted: September 1, 2020
Results First Posted: September 23, 2020
Last Update Posted: October 19, 2020