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Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00312338
Recruitment Status : Completed
First Posted : April 10, 2006
Results First Posted : February 2, 2010
Last Update Posted : November 2, 2012
Sponsor:
Collaborator:
Tufts University
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora

Condition or disease Intervention/treatment Phase
Bacterial Conjunctivitis Drug: VIGAMOX Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora
Study Start Date : June 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pink Eye

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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



Eligibility Criteria
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Ages Eligible for Study:   1 Year to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312338


Locations
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United States, Texas
Multiple Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Tufts University
Investigators
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Principal Investigator: Steven J. Lichtenstein, M.D. Investigator / Contact
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00312338    
Other Study ID Numbers: CMS-05-11
First Posted: April 10, 2006    Key Record Dates
Results First Posted: February 2, 2010
Last Update Posted: November 2, 2012
Last Verified: February 2010
Additional relevant MeSH terms:
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Conjunctivitis, Bacterial
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Eye Infections
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
 Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female