Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes

A Randomized, Double-Blind, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspension (Par) Compared to CIPRODEX® (Ciprofloxacin 0.3%/Dexamethasone 0.1%) Sterile Otic Suspension (Alcon) in the Treatment of Acute Bacterial Otitis Media in Children With Patent Tympanostomy Tubes

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01994642

Enrollment

203

Registered

2013-11-26

Start date

2013-11-30

Completion date

2015-03-31

Last updated

2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media in Patients With Tympanostomy Tubes

Brief summary

The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis media in children with patent tympanostomy tubes.

Interventions

DRUGCiprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension

DRUGCIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)

DRUGPlacebo Sterile Otic Suspension

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Months to 12 Years

Healthy volunteers

Inclusion criteria

1. Male or female aged 6 months-12 years of age inclusive. 2. Parent or legal guardian has signed informed consent form, which meets all of the criteria of current FDA regulations. 3. Based on the patient's age, comprehension and communication developmental skills has provided assent to participate in an appropriate format. 4. Confirmed insertion of a patent tympanostomy tube(s) in the infected ear(s). 5. Clinical signs and symptoms consistent with acute bacterial otitis media in at least one ear and a score of at least 2 for otorrhea using the following scale 0=none, 1=mild, 2=moderate, 3=severe, (see Appendix A for rating scale and severity definitions). 6. Otorrhea has been present for 21 days or less. 7. The presence of infection confirmed by a positive bacterial culture for the presence of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis or Pseudomonas aeruginosa. As the results of the bacterial culture will not be immediately known, patients who meet all the other inclusion/

Exclusion criteria

may be enrolled in the study pending the results of the bacterial culture.

Design outcomes

Primary

Measure	Time frame	Description
Clinical Success	Day 14-21	A patient who is considered a clinical success at Visit 4 (Test of Cure/End of Study) will have no signs or symptoms of active AOMT that were present at baseline nor any new signs or symptoms of AOMT have developed

Secondary

Measure	Time frame
Cessation of Otorrhea	Day 14-21

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026