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

• Status: Completed
• Trial end date: 2015-08-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Exela Pharma Sciences, LLC.
• Treatments: BB 1101; Ciprofloxacin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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.