Skip to content

The effectiveness of Neomycin sulphate, Polymyxin B sulphate, Gramicidin combined drug compared with Ofloxacin for treatment of uncomplicated acute otitis externa

Neomycin sulphate, Polymyxin B sulfate, Gramicidin (Poly-oph) versus 0.3% Ofloxacin(Floxy) for treatment of uncomplicated acute otitis externa

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241117006
Enrollment
118
Registered
2024-11-17
Start date
2024-10-19
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

patients aged 18 to 65 years were diagnosed with acute otitis externa by an otorhinolaryngologist within 3 weeks acute otitis externa, Neomycin sulphate, Polymyxin B sulphate, Gramicidin, Ofloxacin

Interventions

combined ototopical drug (polymyxin B 5,000 iu, neomycin 2 mg and gramicidin 0.025 mg) 1. lying down and the ear positioned upward 2. two drops can then be placed along the side of the ear canal 3. l
Active Comparator Drug,Active Comparator Drug
Neomycin sulphate, Polymyxin B sulphate, Gramicidin combined ear drop ,Ofloxacin ear drop

Sponsors

KHON KAEN UNIVERSITY
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. patients aged 18 to 65 years 2. diagnosed with acute otitis externa by an otorhinolaryngologist within 3 weeks

Exclusion criteria

Exclusion criteria: 1. contraindications for use of Neomycin sulphate, Polymyxin B sulphate, Gramicidin, Ofloxacin 2. patients who have taken ototopical ear drop in the last 3 weeks 3. patients who have other ears' problem e.g. tympanic membrane perforation, infection 4. during treat otitis externa with other medications 5. patients who can not communicate e.g. multiple handicaps 6. patients who can not come to follow-up 7. severe ear canal swelling, can not evaluate ear drum

Design outcomes

Primary

MeasureTime frame
improvement of acute otitis externa at 1 and 2 weeks after treated with ear drops clinical symptoms score

Secondary

MeasureTime frame
Pathogen of otitis externa 1 and 2 weeks after start ototopical drug Ear tissue culture

Countries

Thailand

Contacts

Public ContactPaunchanit Warathisapong

Khonkaen university

Paunwa@kku.ac.th66935581116

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026