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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

2014-08-27 03:12:24 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Otitis Externa

Intervention

0.3% Ciprofloxacin Ear Drops, FoamOtic Cipro

Location

Wolfson Medical Center
Holon
Israel
58100

Status

Recruiting

Source

Otic Pharma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:24-0400

Clinical Trials [408 Associated Clinical Trials listed on BioPortfolio]

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

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 hypo...

OTO-201 for the Treatment of Otitis Externa

This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is...

FST-201 In The Treatment of Acute Otitis Externa

The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug App...

Phase 3 Study of OTO-201 in Acute Otitis Externa

This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a sing...

Topical Voltaren in Otitis Externa

Voltaren being a Non-steroidal anti-inflammatory drug (NSAID) drug may be used as a single drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption of ...

PubMed Articles [426 Associated PubMed Articles listed on BioPortfolio]

Comparison of two ear cytological collection techniques in dogs with otitis externa.

Canine otitis externa is a common disease. Cytological evaluation of otic exudate is a useful diagnostic test to direct and monitor treatment for otitis externa. One method of collecting ear cytologic...

Ciprofloxacin vs. temperature: Antibiotic toxicity in the free-floating liverwort Ricciocarpus natans from a climate change perspective.

The physiological responses of the aquatic liverwort Ricciocarpus natans to ciprofloxacin (Cipro) exposure under different growth temperatures were investigated. Cipro appears to act as an inhibitor o...

Analysis of the otic mycobiota in dogs with otitis externa compared to healthy individuals.

Otitis externa is a common multifactorial disease with a prevalence in dogs as high as 10-20%. In humans, the diversity of the cutaneous mycobiota appears to increase in diseased states, whereas one c...

Imaging in the Diagnosis and Management of Necrotizing Otitis Externa: A Survey of Practice Patterns.

To survey neurotologists and head and neck radiologists regarding use of imaging in the diagnosis and management of necrotizing otitis externa (NOE).

Genetic relationships and population structure of Malassezia pachydermatis strains isolated from dogs with otitis externa and healthy dogs.

Malassezia pachydermatis causes infections of the skin and mucous membranes, especially in animals. It is commonly accepted that symptom manifestation depends on the physiological status of the host (...

Medical and Biotech [MESH] Definitions

Inflammation of the ear, which may be marked by pain (EARACHE), fever, HEARING DISORDERS, and VERTIGO. Inflammation of the external ear is OTITIS EXTERNA; of the middle ear, OTITIS MEDIA; of the inner ear, LABYRINTHITIS.

Inflammation of the OUTER EAR including the external EAR CANAL, cartilages of the auricle (EAR CARTILAGE), and the TYMPANIC MEMBRANE.

The administration of therapeutic agents drop by drop, as eye drops, ear drops, or nose drops. It is also administered into a body space or cavity through a catheter. It differs from irrigation in that the irrigate is removed within minutes, but the instillate is left in place.

A broad-spectrum antimicrobial carboxyfluoroquinoline.

Inflammation of the middle ear with purulent discharge.

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