Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02216071
Recruitment Status : Completed
First Posted : August 13, 2014
Results First Posted : May 28, 2021
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Exela Pharma Sciences, LLC.

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Otitis Externa Drug: Ciprodex® Drug: EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 499 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 20, 2014
Actual Primary Completion Date : August 11, 2015
Actual Study Completion Date : August 11, 2015


Arm Intervention/treatment
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 Name: Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Number of Participants With Adverse Events [ Time Frame: Each monitoring visit through 15 +/- 1 days ]

    Safety outcomes evaluated

    • AEs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216071


Locations
Show Show 48 study locations
Sponsors and Collaborators
Exela Pharma Sciences, LLC.
Investigators
Layout table for investigator information
Study Chair: Michael H Silverman, MD BioStrategics Consulting Ltd
Layout table for additonal information
Responsible Party: Exela Pharma Sciences, LLC.
ClinicalTrials.gov Identifier: NCT02216071    
Other Study ID Numbers: EXL CDOS-300 AOE
First Posted: August 13, 2014    Key Record Dates
Results First Posted: May 28, 2021
Last Update Posted: May 28, 2021
Last Verified: September 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Otitis
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
Ciprofloxacin
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors