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

Effectiveness and safety of 1.5% levofloxacin otic solution (ComplexTM) for treatment of otitis externa without otitis media in a multicenter, open label, non-comparative, phase IV post-marketing study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240177

Enrollment

Registered

2024-06-19

Start date

2024-06-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis externa including myringitis caused by bacteria without otitis media Otitis Externa

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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)

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Efficacy (cure) rate at end of follow-up (EOF)	—

Secondary

Measure	Time frame
(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	—

Contacts

Public ContactYoshinobu Oikawa

Ceolia Pharma, Co., Ltd.

oikawa_yoshinobu@ceolia.co.jp+81-352041911

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026