A Phase 2 interventional study of Ciprodex Otic Suspension and Ciprodexa Otic Foam in Otitis Externa, Otorhinolaryngologic Diseases and Ear Diseases, sponsored by Otic Pharma. Completed at 7 sites in Israel. Open to participants aged 3 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-11-02.
Sponsored by Otic Pharma · Phase 2, Interventional, and Treatment
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).
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 →Otic Pharma is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
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.
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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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ciprodex Sterile Otic Solution (Alcon, Inc.)
Drug: Ciprodex Otic Suspension
Ciprodexa Otic Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone otic foam)
Drug: Ciprodexa Otic Foam
4 gtt b.i.d. for 7 days.
Also known as: Ciprodex, Ciprodex b.i.d.
0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days
Also known as: Ciprofloxacin, Dexamethasone Otic Foam, Ciprodexa foam once-a-day
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]
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Otic Pharma