Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

October 31, 2012 updated by: Alcon Research
Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Multiple locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infected Patient treated with Vigamox
Conjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days.
Drug: VIGAMOX
1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days
No Intervention: Healthy Subjects
Healthy Subjects receiving no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 and Day 42
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
Day 0, Day 42
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
Day 0, Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Collaborators

Tufts University

Investigators

  • Principal Investigator: Steven J. Lichtenstein, M.D., Investigator / Contact

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

April 4, 2006

First Submitted That Met QC Criteria

April 4, 2006

First Posted (Estimate)

April 10, 2006

Study Record Updates

Last Update Posted (Estimate)

November 2, 2012

Last Update Submitted That Met QC Criteria

October 31, 2012

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMS-05-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bacterial Conjunctivitis

Clinical Trials on VIGAMOX

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe