Trial · NCT02216071

Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa

NCT02216071, Phase 3, Completed, Exela Pharma Sciences, LLC.; results first posted 2021-05-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa. Trials, record NCT02216071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02216071

On this page

Trial

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

Title: Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
NCT number: NCT02216071
Status: Completed
Phases: Phase 3
Enrollment: 499 participants, actual
Lead sponsor: Exela Pharma Sciences, LLC.
Conditions: Acute Otitis Externa
Interventions: Ciprodex®, EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension
First posted: 2014-08-13
Last updated: 2021-05-28
Results first posted: 2021-05-28

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Clinical Cure of AOE	7 days after the completion of therapy; at Day 15 (+/- 1 day)	The primary efficacy endpoint was the clinical cure of AOE, defined as the proportion of subjects with a clinical AOE score of 0 at the TOC Visit. Subjects with AOE in both ears were considered to have achieved clinical cure of AOE if the clinical AOE score was 0 for both ears. The clinical AOE score was defined as the sum of scores for inflammation and edema (0=absent, 1=mild, 2=moderate, 3=severe) and tenderness and otorrhea (0=absent, 1=present).
Secondary	Number of Participants With Microbiological Cure (MC)	7 days after the completion of therapy; at Day 15 (+/- 1 day)	The secondary efficacy endpoint was the microbiological cure of AOE, defined as the proportion of subjects with microbiological cure at the TOC Visit. Subjects with AOE in both ears were considered to have achieved microbiological cure if microbiological cure was achieved in both ears.
Other	Number of Participants With Adverse Events	Each monitoring visit through 15 +/- 1 days	Safety outcomes evaluated * AEs

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Clinical Cure of AOE	7 days after the completion of therapy; at Day 15 (+/- 1 day)		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Microbiological Cure (MC)	7 days after the completion of therapy; at Day 15 (+/- 1 day)	The number of participants analyzed represents Bacteria-Positive cohort of subjects	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With Adverse Events	Each monitoring visit through 15 +/- 1 days	499 subjects were randomized as the ITT population, 245 in the EXL CDOS arm \& 254 in the RLD arm. All were included in the safety population, but randomization was modified for 36 subjects in the EXL CDOS arm and 43 subjects in the RLD arm to account for available supply of study drug, making 252 subjects in the EXL CDOS arm \& 247 in the RLD arm.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Units
Number of Participants With Clinical Cure of AOE	Ciprodex®, RLD	190	Participants
Number of Participants With Clinical Cure of AOE	EXL CDOS	191	Participants
Number of Participants With Microbiological Cure (MC)	Ciprodex®, RLD	115	Participants
Number of Participants With Microbiological Cure (MC)	EXL CDOS	117	Participants
Number of Participants With Adverse Events	Ciprodex®, RLD	60	Participants
Number of Participants With Adverse Events	EXL CDOS	67	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ciprodex®, RLD	254
Overall Study	STARTED	EXL CDOS	245
Overall Study	COMPLETED	Ciprodex®, RLD	239
Overall Study	COMPLETED	EXL CDOS	233
Overall Study	NOT COMPLETED	Ciprodex®, RLD	15
Overall Study	NOT COMPLETED	EXL CDOS	12

Source ClinicalTrials.gov

Adverse events28

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	Ear and labyrinth disorder	Ear and labyrinth disorders	Ciprodex®, RLD	18	247
other	Ear and labyrinth disorder	Ear and labyrinth disorders	EXL CDOS	15	252
other	Photophobia	Eye disorders	Ciprodex®, RLD	0	247
other	Photophobia	Eye disorders	EXL CDOS	1	252
other	Gastrointestinal	Gastrointestinal disorders	Ciprodex®, RLD	1	247
other	Gastrointestinal	Gastrointestinal disorders	EXL CDOS	2	252
other	General disorder and administration site conditions	General disorders	Ciprodex®, RLD	3	247
other	General disorder and administration site conditions	General disorders	EXL CDOS	1	252
other	Infections and Infestations	Infections and infestations	Ciprodex®, RLD	13	247
other	Infections and Infestations	Infections and infestations	EXL CDOS	18	252

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ciprodex®, RLD
Total, all-cause mortality	EXL CDOS
Total, other adverse events	Ciprodex®, RLD	47	247
Total, other adverse events	EXL CDOS	42	252
Total, serious adverse events	Ciprodex®, RLD	0	247
Total, serious adverse events	EXL CDOS	1	252

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 comparisons4

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

Comparison	Source
Ciprodex®, RLD vs EXL CDOS: Number of Participants With Adverse Events	Trial comparisons
Ciprodex®, RLD vs EXL CDOS: Number of Participants With Clinical Cure of AOE	Trial comparisons
Ciprodex®, RLD vs EXL CDOS: Number of Participants With Microbiological Cure (MC)	Trial comparisons
Ciprodex®, RLD vs EXL CDOS: serious adverse events	Trial comparisons

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/NCT02216071

GET https://conductscience.org/api/trials/v1/NCT02216071/events?page=2

API reference For AI assistants