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

Acute Otitis Externa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216071
• Other study ID #: EXL CDOS-300 AOE
• Status: Completed
• Phase: Phase 3
• Start date: July 20, 2014
• Est. completion date: August 11, 2015

Study information

• Verified date: September 2020
• Source: Exela Pharma Sciences, LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: August 11, 2015
• Est. primary completion date: August 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Otitis Externa
• Otitis
• Otitis Externa

Intervention

Drug:
• Ciprodex®
Treatment of acute otitis externa (AOE) when administered twice daily for 7 days
• 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

Locations

Country	Name	City	State
Puerto Rico	Advance Medical Concepts, PSC	Cidra
Puerto Rico	Clinical Research Puerto Rico	San Juan
United States	Southland Clinical Research Center	Anaheim	California
United States	Asheboro Research Associates	Asheboro	North Carolina
United States	Pioneer Clinical Research	Bellevue	Nebraska
United States	Southland Clinical Reseach Center	Bellflower	California
United States	Alessi Institute	Beverly Hills	California
United States	Birmingham Pediatric Associates	Birmingham	Alabama
United States	American Clinical Trials	Buena Park	California
United States	Pi-Coor Clinical Research, LLC	Burke	Virginia
United States	Clinix Health Services of Colorado/Clinical Research Advantage, Inc.	Centennial	Colorado
United States	Pediatric Research of Charlottesville, LLC	Charlottesville	Virginia
United States	Sterling Research Group, Ltd	Cincinnati	Ohio
United States	Ericksen Research & Development	Clinton	Utah
United States	Colorado ENT & Allergy	Colorado Springs	Colorado
United States	Colorado Springs Health Partners/Clinical Research Advantage, Inc.	Colorado Springs	Colorado
United States	Research Across America	Dallas	Texas
United States	Hometown Urgent Care and Research	Dayton	Ohio
United States	Horizon Research Group, LLC	Eunice	Louisiana
United States	Cyn3rgy Research	Gresham	Oregon
United States	Direct Helpers Medical Center	Hialeah	Florida
United States	Palm Springs Research Institute	Hialeah	Florida
United States	Gulf Coast Medical Research	Houston	Texas
United States	Children's Clinic of Jonesboro, PA	Jonesboro	Arkansas
United States	NEA Baptist Clinic	Jonesboro	Arkansas
United States	Clinical Research Center for Nevada, LLC	Las Vegas	Nevada
United States	MCS Clinical Trials	Los Angeles	California
United States	Pediatrics & Adolescent Medicine, PA	Marietta	Georgia
United States	Urban Family Practice/Clinical Research Advantage	Marietta	Georgia
United States	Desert Clinical Research/Clinical Research Advantage, Inc.	Mesa	Arizona
United States	Abel & Buchheim PR, Inc.	Miami	Florida
United States	Integrity Clinical Trials, LLC	Miami	Florida
United States	Heugenot Pediatrics, PC	Midlothian	Virginia
United States	Gulf Coast Medical Research	Missouri City	Texas
United States	ProMetrix Clinical Studies	Morganville	New Jersey
United States	Zain Research, LLC	Richland	Washington
United States	Benchmark Research	Sacramento	California
United States	Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc	Sacramento	California
United States	Chyrsalis Clinical Research	Saint George	Utah
United States	J. Lewis Research/First Med East	Salt Lake City	Utah
United States	J. Lewis Research/Foothill Family Clinic South	Salt Lake City	Utah
United States	Benchmark Research	San Angelo	Texas
United States	Mercury Clinical Research, Inc	Splendora	Texas
United States	Gulf Coast Medical Research	Sugar Land	Texas
United States	Whitehouse Station Family Medicine	Whitehouse Station	New Jersey
United States	Professional Research Network of Kansas, LLC	Wichita	Kansas
United States	Piedmont Ear, Nose, and Throat Associates	Winston-Salem	North Carolina
United States	Woburn Pediatric Associates	Woburn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Exela Pharma Sciences, LLC.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Adverse Events	Safety outcomes evaluated; AEs	Each monitoring visit through 15 +/- 1 days
Primary	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).	7 days after the completion of therapy; at Day 15 (+/- 1 day)
Secondary	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.	7 days after the completion of therapy; at Day 15 (+/- 1 day)