Acute Otitis ExternaPhase 3NCT02216071

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

A Phase 3 study testing Ciprodex® and EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension in people with Acute Otitis Externa, run by Exela Pharma Sciences, LLC. at 48 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when administered twice daily for 7 days. Read more about this study

Who is it for?: Ages 6 months and older
Conditions the study is for: Acute Otitis Externa
What is being tested?: Ciprodex® and EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 499 participants
Where: 48 sitesin 2 countries
Study dates: 20 Jul 2014to 11 Aug 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female, 6 months of age and over;
Clinically documented AOE consistent with the diagnostic guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Foundation in 1 or both ears;
Inflammation and/or edema ≥2 on the AOE scale, and otorrhea and/or tenderness present;
AOE of <4 weeks duration;
Intact tympanic membrane(s) in the treated ear(s);
Willingness to refrain from swimming through the TOC/ Visit 5;

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For subjects with AOE associated with hearing aid use, willingness to discontinue the use of hearing aid(s) in the affected ear(s) through the TOC/Visit 5;
Ability to complete the study in compliance with the protocol;
For adult subjects, ability to understand and provide written informed consent; and
For pediatric subjects, a parent or legal guardian has provided written informed consent; and
For children age 6 and above, ability to understand and provide assent according to institutional requirements.

Who cannot join

Acute or chronic suppurative otitis media;
Post-tympanostomy tube acute otorrhea;
Malignant otitis externa;
Suspected or overt fungal or viral ear infection;
Congenital abnormalities or obstructive bony exostoses of the external auditory canal of the treated ear(s);
Seborrheic dermatitis or other dermatologic conditions of the external auditory canal of the treated ear(s) which could confound evaluation;

Show all 25Show fewer

Mastoiditis or other suppurative infectious or non-infectious disorders of the treated ear(s);
Malignant tumors of the external auditory canal of the treated ear(s);
History of otologic surgery of the treated ear(s), with the exception of tympanic membrane surgery >6 months prior to Baseline;
Four or more episodes of otitis externa (OE) in the previous year;
Uncontrolled diabetes mellitus;
Immunosuppressive disorder, including known Human Immunodeficiency Virus infection;
Renal insufficiency;
Hepatitis or hepatic insufficiency;
Receipt of systemic antibiotic concurrently or within 72 hours prior to Baseline;
Receipt of topical otic antibiotic within 24 hours prior to Baseline;
Use of systemic corticosteroid concurrently or within 30 days prior to Baseline;
Use of topical otic corticosteroids concurrently or within 7 days prior to Baseline;
Concurrent use of systemic or topical otic nonsteroidal or other anti-inflammatory drugs;
Use of topical vinegar, alcohol, or other astringent otic preparations concurrently or within 24 hours prior to Baseline;
Pregnancy, planned pregnancy, or lactation;
Known sensitivity or intolerance to quinolone antibacterial agents;
Previous participation in this trial;
Participation in another investigational drug or vaccine trial concurrently or within 30 days; or
Significant acute or chronic medical, neurologic, or psychiatric illness in the subject or parent/guardian that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.

Trial locations and contacts

48 sites in 2 countries.

Country

City, postcode or hospital

48 sites in 2 countries

United States46 sites

Southland Clinical Research Center
Anaheim, California, 92804
Asheboro Research Associates
Asheboro, North Carolina, 27203
Pioneer Clinical Research
Bellevue, Nebraska, 68005
Southland Clinical Reseach Center
Bellflower, California, 90706
Alessi Institute
Beverly Hills, California, 90212
Birmingham Pediatric Associates
Birmingham, Alabama, 35205
American Clinical Trials
Buena Park, California, 90620
Pi-Coor Clinical Research, LLC
Burke, Virginia, 22015
Clinix Health Services of Colorado/Clinical Research Advantage, Inc.
Centennial, Colorado, 80112
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
Sterling Research Group, Ltd
Cincinnati, Ohio, 45246
Ericksen Research & Development
Clinton, Utah, 84015
Colorado ENT & Allergy
Colorado Springs, Colorado, 80909
Colorado Springs Health Partners/Clinical Research Advantage, Inc.
Colorado Springs, Colorado, 80920
Research Across America
Dallas, Texas, 75234
Hometown Urgent Care and Research
Dayton, Ohio, 45424
Horizon Research Group, LLC
Eunice, Louisiana, 70535
Cyn3rgy Research
Gresham, Oregon, 97030
Direct Helpers Medical Center
Hialeah, Florida, 33012
Palm Springs Research Institute
Hialeah, Florida, 33012
Gulf Coast Medical Research
Houston, Texas, 77025
Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, 72401
NEA Baptist Clinic
Jonesboro, Arkansas, 72401
Clinical Research Center for Nevada, LLC
Las Vegas, Nevada, 89104
MCS Clinical Trials
Los Angeles, California, 90017
Pediatrics & Adolescent Medicine, PA
Marietta, Georgia, 30062
Urban Family Practice/Clinical Research Advantage
Marietta, Georgia, 30067
Desert Clinical Research/Clinical Research Advantage, Inc.
Mesa, Arizona, 85213
Abel & Buchheim PR, Inc.
Miami, Florida, 33165
Integrity Clinical Trials, LLC
Miami, Florida, 33165
Heugenot Pediatrics, PC
Midlothian, Virginia, 23113
Gulf Coast Medical Research
Missouri City, Texas, 77459
ProMetrix Clinical Studies
Morganville, New Jersey, 07751
Zain Research, LLC
Richland, Washington, 97030
Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc
Sacramento, California, 95815
Benchmark Research
Sacramento, California, 95822
J. Lewis Research/First Med East
Salt Lake City, Utah, 84121
J. Lewis Research/Foothill Family Clinic South
Salt Lake City, Utah, 84121
Benchmark Research
San Angelo, Texas, 76904
Mercury Clinical Research, Inc
Splendora, Texas, 77372
Chyrsalis Clinical Research
St. George, Utah, 84790
Gulf Coast Medical Research
Sugar Land, Texas, 77478
Whitehouse Station Family Medicine
Whitehouse Station, New Jersey, 08889
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67203
Piedmont Ear, Nose, and Throat Associates
Winston-Salem, North Carolina, 27103
Woburn Pediatric Associates
Woburn, Massachusetts, 01801

Other trials in United States

Puerto Rico2 sites

Advance Medical Concepts, PSC
Cidra, 00739
Clinical Research Puerto Rico
San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study of the Comparative Efficacy and Safety of EXL CDOS in Subjects With Acute Otitis Externa

Read the detailed description

This was a Phase 3, multicenter, randomized, double-blind, active-controlled, parallel-group study in adults and children (age 6 months and older) with a diagnosis of AOE with a 2-day screening period followed by a 2-week participation period. Subjects were administered study drug, EXL CDOS or RLD, 4 drops in the affected ear(s) BID for 7 days. The primary endpoint, the proportion of subjects with a clinical AOE score of 0, was measured at the TOC Visit on Day 15.

Conditions: Acute Otitis Externa
Being tested: Ciprodex®, EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ciprodex®Drug
Treatment of acute otitis externa (AOE) when administered twice daily for 7 days
EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic SuspensionDrug
Also called Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension
Treatment of acute otitis externa (AOE) when administered twice daily for 7 days

Study groups in NCT02216071
Study group	Role	What they receive
Ciprodex®, RLD	Active comparator	Ciprodex®, Otic Suspension, Twice daily for 7 days Receives: Drug: Ciprodex®
EXL CDOS	Experimental	EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days Receives: Drug: EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Clinical Cure of AOE
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).
Measured: 7 days after the completion of therapy; at Day 15 (+/- 1 day)

Secondary outcomes (1)

Number of Participants With Microbiological Cure (MC)
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.
Measured: 7 days after the completion of therapy; at Day 15 (+/- 1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 201411 Aug 2015

First posted13 Aug 2014 (estimated)
Study start20 Jul 2014
Primary completion11 Aug 2015
Study completion11 Aug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Otitis ExternaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 499 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02216071
Sponsor's protocol ID: EXL CDOS-300 AOE
Status last verified: Sep 2020
First submitted: 11 Aug 2014
Last updated: 28 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study of the Comparative Efficacy and Safety of EXL CDOS in Subjects With Acute Otitis Externa
ClinicalTrials.gov ID: NCT02216071
Acronym / sponsor ID: EXL CDOS-300 AOE
Conditions: Acute Otitis Externa
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 499 participants (actual)
Lead sponsor: Exela Pharma Sciences, LLC.Industry (pharma, biotech, devices)
Study start: 20 Jul 2014 (actual)
Primary completion: 11 Aug 2015 (actual)
Study completion: 11 Aug 2015 (actual)
First posted: 13 Aug 2014 (estimated)
Results: Posted 28 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ciprodex®, RLD	Active comparator	Drug: Ciprodex®Ciprodex®, Otic Suspension, Twice daily for 7 days
EXL CDOS	Experimental	Drug: EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic SuspensionEXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Male or female, 6 months of age and over;
Clinically documented AOE consistent with the diagnostic guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Foundation in 1 or both ears;
Inflammation and/or edema ≥2 on the AOE scale, and otorrhea and/or tenderness present;
AOE of <4 weeks duration;
Intact tympanic membrane(s) in the treated ear(s);

Key exclusion criteria (25 listed)

Acute or chronic suppurative otitis media;
Post-tympanostomy tube acute otorrhea;
Malignant otitis externa;
Suspected or overt fungal or viral ear infection;
Congenital abnormalities or obstructive bony exostoses of the external auditory canal of the treated ear(s);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ciprodex®Treatment of acute otitis externa (AOE) when administered twice daily for 7 days	Drug	Ciprodex®, RLD
EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic SuspensionAlso: Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic SuspensionTreatment of acute otitis externa (AOE) when administered twice daily for 7 days	Drug	EXL CDOS

Primary outcome

Number of Participants With Clinical Cure of AOE
Time frame: 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).

1 secondary outcome

Number of Participants With Microbiological Cure (MC)
Time frame: 7 days after the completion of therapy; at Day 15 (+/- 1 day)

Results and safety

Results posted to the registry on 28 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ciprodex®, RLD	254	239
EXL CDOS	245	233

Primary outcome: Number of Participants With Clinical Cure of AOE

Time frame: 7 days after the completion of therapy; at Day 15 (+/- 1 day). Count of participants. Unit: Participants

Measure	Ciprodex®, RLD n = 254	EXL CDOS n = 245
Value	190	191

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ciprodex®, RLD	0 of 247 (0%)	47 of 247 (19%)	Not reported
EXL CDOS	1 of 252 (0.4%)	42 of 252 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael H Silverman, MD study chair

BioStrategics Consulting Ltd

48 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinical Cure of AOE (time frame: 7 days after the completion of therapy; at Day 15 (+/- 1 day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02216071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (11 listed)

Key exclusion criteria (25 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Number of Participants With Clinical Cure of AOE

Adverse events

Research links

Related trials for Acute Otitis Externa

Emerging Indications for Hyperbaric Oxygen Treatment

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Number of Participants With Clinical Cure of AOE

Adverse events