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CompletedNCT00872209Updated Dec 24, 2009

Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa

A Phase 1/2 interventional study of 0.3% Ciprofloxacin Ear Drops and 0.3% Ciprofloxacin Foam Otic Cipro in Otitis Externa, Otorhinolaryngologic Diseases and Ear Diseases, sponsored by Otic Pharma. Completed at 4 sites in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-12-24.

Sponsored by Otic Pharma · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel medication developed to treat Acute Diffuse Otitis Externa of bacterial origin.

The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.

Read the detailed description

Acute otitis externa (AOE) is defined as a diffuse inflammation of the external ear canal, which may also involve the pinna and/or the tympanic membrane. AOE is one of the most common infections encountered by otolaryngologists, pediatricians and family physicians. The reported annual incidence of AOE is between 1:100 and 1:250 in the general population with large seasonal and regional variations. Diagnosis of AOE requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal inflammation which includes: A) otalgia (often severe), itching or fullness, sometimes accompanied by reduced hearing or jaw pain; B) tenderness of the tragus and/or pinna; and C) diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge.

02

Conditions studied

  • Otitis Externa
  • Otorhinolaryngologic Diseases
  • Ear Diseases
  • Otitis

Keywords

  • swimmer's ear
  • ear drops
  • ear foam
  • otic foam
  • ear infection
  • ear pain
  • ear inflammation
03

In context

Otitis Externa

22 studies on the registry are indexed under Otitis Externa; 1 is open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 20 interventional studies indexed under Otitis Externa.

Browse Otitis Externa studies →

Lead sponsor

Otic Pharma is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18 and older eligible to sign by themselves.
  • Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and of presumed bacterial origin.
  • Intact tympanic membrane
  • Unilateral Acute Otitis Externa

Exclusion criteria

Exclusion Criteria:

  • Known allergy or sensitivity to Ciprofloxacin or other quinolones.
  • Clinical Diagnosis of chronic suppurative otitis media (CSOM), acute otitis media (AOM), involvement of middle ear effusion (MEE).
  • Patient has the non intact tympanic membrane.
  • Patient has a serious underlying disease.
  • Patients with known history of immune dysfunction/deficiency and those receiving therapy.
  • Patients with history of Diabetes mellitus.
  • Bilateral Acute Otitis Externa.
  • Patients with more than 80% of the ear canal occluded.
  • Pregnant or lactating patients.
  • Overt fungal Acute Otitis Externa.
  • Local ear canal abnormalities such as abscess, granulation or polyps.
  • Congenital abnormalities of the external auditory canal or obstructive bony exostosis in the treated ear.
  • Mastoid or other suppurative non-infectious ear disorder (e.g. cholesteatoma) in the treated ear.
  • Seborrheic dermatitis or other dermatological conditions of the external auditory canal which would complicate evaluation.
  • Current Infection requiring systemic antimicrobial therapy.
  • Current or previous use of topical or oral antibiotics (within 3 days) or long-acting antibiotics (within 7 days).
  • Current enrollment in an drug or device study or participation in such a study within 30 days of entry into this study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Ciloxan Ear Drops

    Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops

    Drug: 0.3% Ciprofloxacin Ear Drops

  • Experimental
    Foam Otic Cipro

    Patients randomized to this study arm will receive the experimental product

    Drug: 0.3% Ciprofloxacin Foam Otic Cipro

Interventions

06

What researchers measure

Primary outcomes

  1. Clinical cure confirmed by significant reduction or absence of the disease symptoms a) Otalgia, b) tenderness with movement of pinna, and c) edema/ear canal occlusion

    Time frame: within 7 days after completion of treatment (BID, for 7 days)

07

Study locations

4 sites
  • HaEmek Medical Center
    Afula, Israel
  • Wolfson Medical Center
    Holon, 58100, Israel
  • Maccabi Healthcare Services
    Tel Aviv, 68125, Israel
  • Assaf Harofeh Medical Center
    Zerifin, 70300, Israel
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2009, a primary completion of Oct 2009 and a completion of Nov 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2009
First posted
Mar 31, 2009
Start
May 2009
Primary completionActual
Oct 2009
CompletionActual
Nov 2009
Last update
Dec 24, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00872209
Lead sponsor
Otic Pharma
First posted
Mar 31, 2009
Start date
May 2009
Primary completion
Oct 2009
Completion
Nov 2009
Last update
Dec 24, 2009

Study contacts

Yehudah Roth, MD
principal investigator · Edith Wolfson Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ciprofloxacin

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