ANTIBIOTICS VERSUS PLACEBO FOR ACUTE BACTERIAL CONJUNCTIVITIS IN CHILDRE

Phase 1

• Conditions: Acute conjunctivitis; MedDRA version: 16.1Level: LLTClassification code 10000695Term: Acute conjunctivitisSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2013-005623-16-FI
• Lead Sponsor: Minna Honkila

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-28
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified