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

May 27, 2021 updated by: Exela Pharma Sciences, LLC.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
499

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Cidra, Puerto Rico, 00739
        • Advance Medical Concepts, PSC
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Birmingham Pediatric Associates
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Desert Clinical Research/Clinical Research Advantage, Inc.
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Children's Clinic of Jonesboro, PA
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Clinic
    • California
      • Anaheim, California, United States, 92804
        • Southland Clinical Research Center
      • Bellflower, California, United States, 90706
        • Southland Clinical Reseach Center
      • Beverly Hills, California, United States, 90212
        • Alessi Institute
      • Buena Park, California, United States, 90620
        • American Clinical Trials
      • Los Angeles, California, United States, 90017
        • Mcs Clinical Trials
      • Sacramento, California, United States, 95815
        • Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc
      • Sacramento, California, United States, 95822
        • Benchmark Research
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Clinix Health Services of Colorado/Clinical Research Advantage, Inc.
      • Colorado Springs, Colorado, United States, 80909
        • Colorado ENT & Allergy
      • Colorado Springs, Colorado, United States, 80920
        • Colorado Springs Health Partners/Clinical Research Advantage, Inc.
    • Florida
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Medical Center
      • Hialeah, Florida, United States, 33012
        • Palm Springs Research Institute
      • Miami, Florida, United States, 33165
        • Abel & Buchheim PR, Inc.
      • Miami, Florida, United States, 33165
        • Integrity Clinical Trials, LLC
    • Georgia
      • Marietta, Georgia, United States, 30062
        • Pediatrics & Adolescent Medicine, PA
      • Marietta, Georgia, United States, 30067
        • Urban Family Practice/Clinical Research Advantage
    • Kansas
      • Wichita, Kansas, United States, 67203
        • Professional Research Network of Kansas, LLC
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Horizon Research Group, LLC
    • Massachusetts
      • Woburn, Massachusetts, United States, 01801
        • Woburn Pediatric Associates
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
        • Pioneer Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Clinical Research Center for Nevada, LLC
    • New Jersey
      • Morganville, New Jersey, United States, 07751
        • ProMetrix Clinical Studies
      • Whitehouse Station, New Jersey, United States, 08889
        • Whitehouse Station Family Medicine
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Asheboro Research Associates
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Ear, Nose, and Throat Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Sterling Research Group, Ltd
      • Dayton, Ohio, United States, 45424
        • Hometown Urgent Care and Research
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Cyn3rgy Research
    • Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Houston, Texas, United States, 77025
        • Gulf Coast Medical Research
      • Missouri City, Texas, United States, 77459
        • Gulf Coast Medical Research
      • San Angelo, Texas, United States, 76904
        • Benchmark Research
      • Splendora, Texas, United States, 77372
        • Mercury Clinical Research, Inc
      • Sugar Land, Texas, United States, 77478
        • Gulf Coast Medical Research
    • Utah
      • Clinton, Utah, United States, 84015
        • Ericksen Research & Development
      • Saint George, Utah, United States, 84790
        • Chyrsalis Clinical Research
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research/First Med East
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research/Foothill Family Clinic South
    • Virginia
      • Burke, Virginia, United States, 22015
        • PI-Coor Clinical Research, LLC
      • Charlottesville, Virginia, United States, 22902
        • Pediatric Research of Charlottesville, LLC
      • Midlothian, Virginia, United States, 23113
        • Heugenot Pediatrics, PC
    • Washington
      • Richland, Washington, United States, 97030
        • Zain Research, Llc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female, 6 months of age and over;
  2. Clinically documented AOE consistent with the diagnostic guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Foundation in 1 or both ears;
  3. Inflammation and/or edema ≥2 on the AOE scale, and otorrhea and/or tenderness present;
  4. AOE of <4 weeks duration;
  5. Intact tympanic membrane(s) in the treated ear(s);
  6. Willingness to refrain from swimming through the TOC/ Visit 5;
  7. 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;
  8. Ability to complete the study in compliance with the protocol;
  9. For adult subjects, ability to understand and provide written informed consent; and
  10. For pediatric subjects, a parent or legal guardian has provided written informed consent; and
  11. For children age 6 and above, ability to understand and provide assent according to institutional requirements.

Exclusion Criteria:

  1. Acute or chronic suppurative otitis media;
  2. Post-tympanostomy tube acute otorrhea;
  3. Malignant otitis externa;
  4. Suspected or overt fungal or viral ear infection;
  5. Congenital abnormalities or obstructive bony exostoses of the external auditory canal of the treated ear(s);
  6. Seborrheic dermatitis or other dermatologic conditions of the external auditory canal of the treated ear(s) which could confound evaluation;
  7. Mastoiditis or other suppurative infectious or non-infectious disorders of the treated ear(s);
  8. Malignant tumors of the external auditory canal of the treated ear(s);
  9. History of otologic surgery of the treated ear(s), with the exception of tympanic membrane surgery >6 months prior to Baseline;
  10. Four or more episodes of otitis externa (OE) in the previous year;
  11. Uncontrolled diabetes mellitus;
  12. Immunosuppressive disorder, including known Human Immunodeficiency Virus infection;
  13. Renal insufficiency;
  14. Hepatitis or hepatic insufficiency;
  15. Receipt of systemic antibiotic concurrently or within 72 hours prior to Baseline;
  16. Receipt of topical otic antibiotic within 24 hours prior to Baseline;
  17. Use of systemic corticosteroid concurrently or within 30 days prior to Baseline;
  18. Use of topical otic corticosteroids concurrently or within 7 days prior to Baseline;
  19. Concurrent use of systemic or topical otic nonsteroidal or other anti-inflammatory drugs;
  20. Use of topical vinegar, alcohol, or other astringent otic preparations concurrently or within 24 hours prior to Baseline;
  21. Pregnancy, planned pregnancy, or lactation;
  22. Known sensitivity or intolerance to quinolone antibacterial agents;
  23. Previous participation in this trial;
  24. Participation in another investigational drug or vaccine trial concurrently or within 30 days; or
  25. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ciprodex®, RLD
Ciprodex®, Otic Suspension, Twice daily for 7 days
Drug: Ciprodex®
Treatment of acute otitis externa (AOE) when administered twice daily for 7 days
Experimental: EXL CDOS
EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days
Drug: EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension
Treatment of acute otitis externa (AOE) when administered twice daily for 7 days
Other Names:
  • Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
7 days after the completion of therapy; at Day 15 (+/- 1 day)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Microbiological Cure (MC)
Time Frame: 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.
7 days after the completion of therapy; at Day 15 (+/- 1 day)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: Each monitoring visit through 15 +/- 1 days

Safety outcomes evaluated

  • AEs
Each monitoring visit through 15 +/- 1 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Exela Pharma Sciences, LLC.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Michael H Silverman, MD, BioStrategics Consulting Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EXL CDOS-300 AOE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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