Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa
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ClinicalTrials.gov Identifier: NCT00872209 |
Recruitment Status :
Completed
First Posted : March 31, 2009
Last Update Posted : December 24, 2009
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Otitis Externa Otorhinolaryngologic Diseases Ear Diseases Otitis | Drug: 0.3% Ciprofloxacin Ear Drops Drug: 0.3% Ciprofloxacin Foam Otic Cipro | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Bioequivalence of Ciprofloxacin 0.3%: a Randomized, Multicenter, Parallel, Comparative Study on the Safety and Efficacy of Ciprofloxacin 0.3% in a Standard Solution or Foam Solution, in Patients With Acute External Otitis. |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | November 2009 |

Arm | Intervention/treatment |
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Active Comparator: Ciloxan Ear Drops
Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops
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Drug: 0.3% Ciprofloxacin Ear Drops
4 gtt BID for 7 days.
Other Names:
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Experimental: Foam Otic Cipro
Patients randomized to this study arm will receive the experimental product
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Drug: 0.3% Ciprofloxacin Foam Otic Cipro
1 application, BID for 7 days
Other Names:
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- 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) ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- 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 immunosuppressive 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 investigational drug or device study or participation in such a study within 30 days of entry into this study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872209
Israel | |
HaEmek Medical Center | |
Afula, Israel | |
Wolfson Medical Center | |
Holon, Israel, 58100 | |
Maccabi Healthcare Services | |
Tel Aviv, Israel, 68125 | |
Assaf Harofeh Medical Center | |
Zerifin, Israel, 70300 |
Principal Investigator: | Yehudah Roth, MD | Edith Wolfson Medical Center |
Responsible Party: | Dr. Rodrigo Yelin (Study Director), Otic Pharma LTD |
ClinicalTrials.gov Identifier: | NCT00872209 |
Other Study ID Numbers: |
OP-001-00 |
First Posted: | March 31, 2009 Key Record Dates |
Last Update Posted: | December 24, 2009 |
Last Verified: | December 2009 |
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Otitis Ear Diseases Otitis Externa Otorhinolaryngologic Diseases Ciprofloxacin Anti-Bacterial Agents Anti-Infective Agents |
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