A 1.5% levofloxacin otic solution (ComplexTM) post-marketing study in patients with otitis externa

JRCT ID: jRCT2031240177

Registered date:19/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Otitis externa including myringitis caused by bacteria without otitis media
• Date of first enrollment: 19/06/2024
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Instill 6 to 10 drops of Comlex ottic solution 1.5% into the affected ear twice a day. After applying the ear drops, keep ear(s) tilted for about 10 minutes. The administration period is 7 to 14 days.

Outcome(s)

• Primary Outcome: Efficacy (cure) rate at end of follow-up (EOF)

Secondary Outcome

(1) Effective (cure) rate at end of treatment (EOT)
(2) Improvement rate in external auditory canal symptoms and findings at EOT and EOF
(3) Period until ear canal secretion stops
(4) Period until the auditory symptoms disappear
(5) Bacteriological effect

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients diagnosed with otitis externa or myringitis caused by bacteria who meet the following criteria. The affected ear(s) are acceptable for one or binaural.
- Patients with either swelling or redness of the external auditory canal (including the tympanic membrane)
- Patients with the external auditory canal secretion (otorrhea)
- Patients with subjective ear symptoms (otalgia or ear fullness)

Exclude criteria

- Patients with otitis media
- Patients with tympanic membrane perforation or transtympanic ventilation tube placement
- Patients with malignant otitis externa or cholesteatoma of the external auditory canal, or patients with a history of radiation therapy that includes the irradiated area of the external auditory canal, which has a risk of malignant otitis externa.
- Patients with signs of fungal, tuberculosis, or viral infection in the ear canal or tympanic membrane
- Patients with otitis interna
- Patients implanted otology-related medical devices such as cochlear implants
- Patients with comorbidities such as serious respiratory diseases, liver disorders, kidney disorders, cardiovascular disorders, blood disorders, endocrine disorders, etc. that may interfere with treatment compliance.
- Patients with a history of allergy to levofloxacin hydrate or quinolone antibacterial agents

Related Information

• Primary Sponsor: Tomohiro Haga
• Secondary Sponsor: Haga Tomohiro,NANO MRNA Co., Ltd.