NCT00312338

Brief Summary

Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

February 2, 2010

Completed
Last Updated

November 2, 2012

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

April 4, 2006

Results QC Date

July 15, 2009

Last Update Submit

October 31, 2012

Conditions

Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Infected Patient treated with Vigamox

EXPERIMENTAL

Conjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days.

Drug: VIGAMOX

Healthy Subjects

NO INTERVENTION

Healthy Subjects receiving no treatment

Interventions

VIGAMOXDRUG

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

Infected Patient treated with Vigamox

Eligibility Criteria

Age1 Year - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Eye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

Limited source documents.

Results Point of Contact

Title
Alcon Clinical
Organization
Alcon Research, Ltd.
medinfo@alconlabs.com
888.451.3937; 817.568.6725

Study Officials

  • Steven J. Lichtenstein, M.D.

    Investigator / Contact

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 10, 2006

Study Start

June 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

November 2, 2012

Results First Posted

February 2, 2010

Record last verified: 2010-02

Locations

US(1)