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Efficacy and safety of Polyspectran® drops, preserved with benzalkonium chloride vs. glycerol ear drops in patients with acute bacterial otitis externa – A double-blind, multicenter, prospective, randomized, and controlled clinical phase III study.

Efficacy and safety of Polyspectran® drops, preserved with benzalkonium chloride vs. glycerol ear drops in patients with acute bacterial otitis externa – A double-blind, multicenter, prospective, randomized, and controlled clinical phase III study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001180-65-DE
Enrollment
Unknown
Registered
2005-09-16
Start date
2005-08-22
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

acute bacterial otitis externa

Interventions

Product Name: Polyspectran drops, preserved with benzalkonium chloride Pharmaceutical Form: Ear drops, solution INN or Proposed INN: Polymyxin B-sulphate Concentration unit: IU/ml international unit(s

Sponsors

Alcon Pharma GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026