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Completed

NCT Number: NCT00312338

Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora

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Key information

Conditions

Bacterial Conjunctivitis Bacterial Infections Bacterial Infections and Mycoses Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Eye Diseases Eye Infections Eye Infections, Bacterial Infections

Age range

1 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Multiple Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vigamox

Drug

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

Primary outcomes

  1. Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation

    Time frame: 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

  2. Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation

    Time frame: 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

  3. Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Collaborators

  • Tufts University

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 10, 2006
Registry last updated
Nov 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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