Trial · NCT02350998

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

NCT02350998, Phase 3, Completed, Otonomy, Inc.; results first posted 2020-09-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration. Trials, record NCT02350998. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02350998

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
NCT number: NCT02350998
Status: Completed
Phases: Phase 3
Enrollment: 33 participants, actual
Lead sponsor: Otonomy, Inc.
Conditions: Bilateral Middle Ear Effusion
Interventions: OTO-201
First posted: 2015-01-30
Last updated: 2020-10-19
Results first posted: 2020-09-23

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Otoscopic Examination: Auricle and Meatus	Up to 1 month	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
Primary	Otoscopic Examination: Tympanic Membrane	up to 1 month	Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Primary	Otoscopic Examination: Tube Patency	Up to 1 month	Subjects with at least one ear tube patent (i.e., not blocked) at Day 29
Secondary	Feasibility of Administration	Day 1	Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either "easy" or "very easy"

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Otoscopic Examination: Auricle and Meatus	Up to 1 month	Safety analysis set : consisted of all enrolled and treated subjects	ears	COUNT_OF_UNITS
PRIMARY	Otoscopic Examination: Tympanic Membrane	up to 1 month	Safety analysis set: all enrolled and treated subjects	ears	COUNT_OF_UNITS
PRIMARY	Otoscopic Examination: Tube Patency	Up to 1 month	Safety analysis set: all enrolled and treated subjects	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Feasibility of Administration	Day 1	Safety analysis set consisted of all enrolled and treated subjects	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Otoscopic Examination: Auricle and Meatus	6mg OTO-201	1	ears
Otoscopic Examination: Tympanic Membrane	6 mg OTO-201	2	ears
Otoscopic Examination: Tube Patency	6 mg OTO-201	32	Participants
Feasibility of Administration	6 mg OTO-201	29	Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	6 mg OTO-201	33
Overall Study	COMPLETED	6 mg OTO-201	33
Overall Study	NOT COMPLETED	6 mg OTO-201	0

Source ClinicalTrials.gov

Adverse events5

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	6 mg OTO-201	7	33
other	Upper Respiratory Infection	Infections and infestations	6 mg OTO-201	3	33
other	Ear Pain	Ear and labyrinth disorders	6 mg OTO-201	4	33
other	Pyrexia	General disorders	6 mg OTO-201	4	33
other	Nasal Congestion	Respiratory, thoracic and mediastinal disorders	6 mg OTO-201	2	33

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	6 mg OTO-201	0	33
Total, other adverse events	6 mg OTO-201	20	33
Total, serious adverse events	6 mg OTO-201	0	33

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02350998

GET https://conductscience.org/api/trials/v1/NCT02350998/registered

API reference For AI assistants