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CompletedNCT01157819Once-a-dayUpdated Mar 15, 2011

Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro Compared to Twice-Daily Dosing of Ciloxan Ear Drops in Patients With Acute External Otitis

A Phase 2 interventional study of 0.3% Ciprofloxacin Ear Drops and FoamOtic Cipro in Otitis Externa, Otorhinolaryngologic Diseases and Ear Diseases, sponsored by Otic Pharma. Completed at 2 sites in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-03-15.

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

Phase
Phase 2
Study type
Interventional
Enrollment
70
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 (0.3% Ciprofloxacin Otic Foam), used once-daily for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to commercial ear drops used twice daily for 7 days.

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. 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 70 is below 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 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 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: FoamOtic Cipro

Interventions

  • Drug0.3% Ciprofloxacin Ear Drops

    4 gtt b.i.d. for 7 days.

    Also known as: Ciloxan, Ciprofloxacin, Cipro

  • DrugFoamOtic Cipro

    0.3% Ciprofloxacin Otic Foam, 1 application, q.d. for 7 days

    Also known as: Ciprofloxacin, Cipro

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 that lasts 7 days

07

Study locations

2 sites
  • Wolfson Medical Center
    Holon, 58100, Israel
  • Bet Roter Clinic, Clalit Health Services
    Holon, 58320, Israel
08

Timeline

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

The record gives a start of Jul 2010, a primary completion of Nov 2010 and a completion of Dec 2010. 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
Jul 4, 2010
First posted
Jul 7, 2010
Start
Jul 2010
Primary completionActual
Nov 2010
CompletionActual
Dec 2010
Last update
Mar 15, 2011
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 Mar 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01157819
Lead sponsor
Otic Pharma
First posted
Jul 7, 2010
Start date
Jul 2010
Primary completion
Nov 2010
Completion
Dec 2010
Last update
Mar 15, 2011

Study contacts

Yehudah Roth, MD
principal investigator · Edith Wolfson Medical Center

Oversight

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

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This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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