A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa

A Randomized, Double-Blind, Placebo-Controlled, 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 Adults With Acute Bacterial Otitis Externa

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01910155

Enrollment

455

Registered

2013-07-29

Start date

2013-07-31

Completion date

2015-03-31

Last updated

2016-10-18

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

Conditions

Otitis Externa

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 Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis externa.

Interventions

DRUGCiprofloxacin/Dexamethasone

DRUGCiprodex (R)

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Male or non-pregnant, non lactating females 18-65 years of age inclusive. 2. Signed informed consent form, which meets all of the criteria of current FDA regulations. 3. If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, injected, transdermal or implanted hormonal contraceptives). Patients on hormonal contraceptives must have been on the same method/type for at least 28 days prior to the start of the study and remain on the same throughout the study. 4. The presence of infection confirmed by a positive bacterial culture for the presence of Pseudomonas aeruginosa or Staphylococcus aureus. 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. 5. Clinical signs and symptoms consistent with bacterial otitis externa as defined by a combined Total Symptom Score (TSS) of at least 6 with a score of least 2 for otalgia using the following scale 0=none, 1=mild, 2=moderate, 3=severe.

Design outcomes

Primary

Measure	Time frame	Description
Clinical Success	Day 14-21	Evaluation of the difference between the proportions of patients considered a clinical success at the End of Study visit

Secondary

Measure	Time frame	Description
Resolution of Symptoms	Day 14-21	The time to complete resolution of disease specific clinically meaningful signs and symptoms at enrollment and the absence of new symptoms

Countries

Puerto Rico, United States

Outcome results

None listed

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