Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

Bacterial Conjunctivitis Clinical Trial

Official title:

Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312338
• Other study ID #: CMS-05-11
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2006
• Last updated: October 31, 2012
• Start date: June 2006
• Est. completion date: June 2007

Study information

• Verified date: February 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 13 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• VIGAMOX
1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days

Locations

Country	Name	City	State
United States	Multiple Locations	Fort Worth	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Alcon Research	Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation	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	Day 0 and Day 42	Yes
Primary	Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation	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	Day 0, Day 42	Yes
Primary	Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation	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	Day 0, Day 42	Yes