Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

Phase 4

Completed

• Conditions: Bacterial Conjunctivitis
• Interventions: Drug: VIGAMOX

• Registration Number: NCT00312338
• Lead Sponsor: Alcon Research

Brief Summary

Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-04
• Study First Submitted QC: 2006-04-04
• Study First Posted: 2006-04-10
• Study Start: 2006-06
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Results First Submitted: 2009-07-15
• Results First Submitted QC: 2010-01-13
• Status Verified: 2010-02
• Results First Posted: 2010-02-02
• Last Update Submitted: 2012-10-31
• Last Update Posted: 2012-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Patients from 1 to 13 years of age that have diagnosis of bacterial conjunctivitis in either or both eyes (for < 3 days duration) based on clinical observation; matched healthy controls

Exclusion Criteria

• Cannot have had bacterial conjunctivitis symptoms as reported by parent for > 2 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infected Patient treated with Vigamox	VIGAMOX	Conjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days.

Primary Outcome Measures

Name	Time	Method
Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation	Day 0 and Day 42	Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).; 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic
Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation	Day 0, Day 42	Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).; 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic
Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation	Day 0, Day 42	Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).; 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic

Trial Locations

Locations (1)

Multiple Locations; 🇺🇸 Fort Worth, Texas, United States