ANTIBIOTICS VERSUS PLACEBO FOR ACUTE BACTERIAL CONJUNCTIVITIS IN CHILDREN

ANTIBIOTICS VERSUS PLACEBO FOR ACUTE BACTERIAL CONJUNCTIVITIS IN CHILDREN: A RANDOMISED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005623-16-FI

Enrollment

240

Registered

2014-02-28

Start date

2014-03-20

Completion date

Unknown

Last updated

2020-05-11

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

Conditions

Acute conjunctivitis MedDRA version: 16.1 Level: LLT Classification code 10000695 Term: Acute conjunctivitis System Organ Class: 100000004853

Interventions

Trade Name: Vigamox Pharmaceutical Form: Eye drops, solution INN or Proposed INN: Moxifloxacin Other descriptive name: MOXIFLOXACIN Concentration unit: mg/ml milligram(s)/millilitre Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The study is conducted on pediatric outpatients from 6 months to 7 years with acute conjunctivitis (the diagnosis of acute conjunctivitis is based on the presence of conjunctival inflammation or discharge) Are the trial subjects under 18? yes Number of subjects for this age range: 240 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: Children with a trauma or a foreign body in the eye and evidence of severe infection are excluded from the study. In addition children who are known to be allergic to fluoroquinolones and have received systemic or topical antibiotics week prior to the diagnosis are not included in this study.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to investigate the benefits of antibiotic therapy (moxifloxacin eye drops) in the management of acute conjunctivitis in children ;Secondary Objective: The aim of the study is to assess the microbiological etiology of acute conjunctivitis in children;Primary end point(s): The primary outcome measure is the length of time from recruitment to clinical cure;Timepoint(s) of evaluation of this end point: 14 days	—

Measure

Time frame

Main Objective: The aim of the study is to investigate the benefits of antibiotic therapy (moxifloxacin eye drops) in the management of acute conjunctivitis in children ;Secondary Objective: The aim of the study is to assess the microbiological etiology of acute conjunctivitis in children;Primary end point(s): The primary outcome measure is the length of time from recruitment to clinical cure;Timepoint(s) of evaluation of this end point: 14 days

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary outcome measure is the length of time from recruitment to release of the symptoms;Timepoint(s) of evaluation of this end point: 14 days	—

Countries

Finland

Contacts

Public ContactMinna Honkila

Minna Honkila

minna.honkila@gmail.com

Outcome results

None listed

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