The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7 days.
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 (otorrhea).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
4 gtt b.i.d. for 7 days.
0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days
Meir Medical Center
Kfar Saba, Israel, Israel
HaEmek Medical Center
Afula, Israel
Soroka Medical Center
Beersheba, Israel
Wolfson Medical Center
Holon, Israel
Clinical cure [lack of need of additional therapy]
Clinical cure \[lack of need of additional therapy\] confirmed by significant reduction or absence of the disease symptoms a) Otalgia/ear pain, b) tenderness with movement of pinna, c) edema/ear canal occlusion and d) ear discharge/otorrhea
Time frame: Between Day 8 and Day 14 [e.g. 7 days after completion of treatment] that lasts 7 days
Otalgia/ear pain
Ear pain as reported by the patient
Time frame: At Visit 1, [Day 1 ,Baseline visit], at Visit 2 [Day 3 - Day 4, during treatment] and at Visit 3 Test-of-cure [Day 8 to Day 14]
Inflammation/ear edema
Time frame: At the test-of-cure visit [Day 8 to Day 14]
Ear discharge/otorrhea
Time frame: At the test-of-cure visit [Day 8 to Day 14]
tenderness with movement of pinna
Time frame: At the test-of-cure visit [Day 8 - Day 14]
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Clalit Health Services - Raziel Clinic
Netanya, Israel
Maccabi Healthcare Services (H.M.O.)
Tel Aviv, Israel
Sourasky Medical Center (Ichilov)
Tel Aviv, Israel