Acute otitis media with otorrhea in tympanostomy tubes MedDRA version: 12.1 Level: LLT Classification code 10033079 Term: Otitis media acute
Conditions
Interventions
Product Name: moxifloxacin 0.5% and dexamethasone sodium phosphate 0.1% (Moxidex)
Product Code: AL-15469A
Pharmaceutical Form: Ear drops, solution
INN or Proposed INN: MOXIFLOXACIN HYDROCHLORIDE
CAS N
Sponsors
Alcon Research Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) At least 6 months and no more than 12 years of age at the time of enrollment 2) Presence of otorrhea at Visit 1 of 21 days or less in duration, visible by the parent/guardian in at least 1 ear 3) Presence of patent tympanostomy tube(s). Patients with obstructed tympanostomy tube(s) that cannot be cleared at the time of enrollment MUST NOT be enrolled 4) Will refrain from significant water immersion of the ear(s) without the use of adequate ear protection during swimming, bathing, showering, and other water-related activities 5) Read and signed (by parent or guardian) the informed consent. When required by the Institutional Review Board, the child must agree to sign an approved assent form 6) Patient and parent/guardian mut agree to comply with the requirements of the study. Parent/guardian must agree to administer the study medication as directed, complete the required study visits, accurately complete twice daily phone calls into the IVRS system, and participate in 5 compliance phone contacts Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patients who have NOT been otorrhea-free for at least seven (7) days following tympanostomy tube surgery 2) Tympanostomy tubes containing antimicrobial agents or any tube longer than 2.5 mm that my prohibit verification of tube patency 3) History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum) 4) Current acute otitis externa (AOE), or malignant otitis externa (MOE) or other conditions which could interfere with evaluatio nof the study drug 5) Known or suspected ear infection of fungal or mycobacterial origin 6) History of/or active herpes simplex, vacinna or varicella infections or overt viral infections of the tympanic membrane (eg, myringitis bullosa) or ear canal. Patients with a history of/or active herpetic infections in locations other than the ear may be enrolled 7) Prior otologic surgery, except those confined to the tympanic membrane, within 1 year or study entry 8) Mastoiditis or other suppurative noninfectious disorders in the ear(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of topical Moxidex for the treatment of patients with acute otitis media with tympanostomy tubes (AOMT); To demonstrate the therapeutic superiority of Moxidex relative to Moxifloxacin based on clinical cures at end of treatment (EOT); To demonstrate therapeutic superiority of Moxifloxacin relative to Vehicle based on clinical cures at EOT. ;Secondary Objective: ;Primary end point(s): Clinical cure rate at the Day 8 (EOT) visit. Clinical cure is attained if the clinical response is resolved/cured (ie, absence of otorrhea) as evaluated by the Investigator (ie, Clinical Response) at the EOT visit. | — |
Countries
Belgium, Denmark, Finland, France
Outcome results
None listed