Bacterial Conjunctivitis
Conditions
Brief summary
Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora
Interventions
DRUGVIGAMOX
1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days
Sponsors
Tufts University
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
1 Years to 13 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation | 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 |
| Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation | 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 |
| Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation | 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 |
Countries
United States
Participant flow
Recruitment details
Study recruitment started in June 2006 and ran until January 29 2008. The study sites included three sites (AZ, CA and IL)
Pre-assignment details
No specific pre-assignment activities.
Participants by arm
| Arm | Count |
|---|---|
| Infected Patients Infected Patients | 105 |
| Healthy Subjects Healthy Subjects | 57 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 2 |
| Overall Study | Lost to Follow-up | 9 | 1 |
| Overall Study | Subsequent infection | 2 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Infected Patients | Healthy Subjects | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 105 Participants | 57 Participants | 162 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 48 Participants | 28 Participants | 76 Participants |
| Sex: Female, Male Male | 57 Participants | 29 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 105 | 0 / 57 |
| serious Total, serious adverse events | 0 / 105 | 0 / 57 |
Outcome results
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
Time frame: Day 0, Day 42
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infected Patients | Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation | Day 0 | 0 Percent of resistant isolates |
| Infected Patients | Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation | Day 42 | 0 Percent of resistant isolates |
| Healthy Subjects | Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation | Day 0 | 0 Percent of resistant isolates |
| Healthy Subjects | Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation | Day 42 | 0 Percent of resistant isolates |
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
Time frame: Day 0, Day 42
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infected Patients | Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation | Day 0 | 8.3 Percent of resistant isolates |
| Infected Patients | Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation | Day 42 | 0 Percent of resistant isolates |
| Healthy Subjects | Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation | Day 0 | 0 Percent of resistant isolates |
| Healthy Subjects | Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation | Day 42 | 0 Percent of resistant isolates |
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
Time frame: Day 0 and Day 42
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infected Patients | Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation | Day 0 | 0 Percent of resistant isolates |
| Infected Patients | Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation | Day 42 | 0 Percent of resistant isolates |
| Healthy Subjects | Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation | Day 0 | 0 Percent of resistant isolates |
| Healthy Subjects | Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation | Day 42 | 0 Percent of resistant isolates |