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| Name | Class |
|---|---|
| Tufts University | OTHER |
Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infected Patient treated with Vigamox | Experimental | Conjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days. |
|
| Healthy Subjects | No Intervention | Healthy Subjects receiving no treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIGAMOX | Drug | 1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven J. Lichtenstein, M.D. | Investigator / Contact | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Fort Worth | Texas | 76134 | United States |
No specific pre-assignment activities.
Study recruitment started in June 2006 and ran until January 29 2008. The study sites included three sites (AZ, CA and IL)
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| ID | Title | Description |
|---|---|---|
| FG000 | Infected Patients | Infected Patients |
| FG001 | Healthy Subjects | Healthy Subjects |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infected Patients | Infected Patients |
| BG001 | Healthy Subjects | Healthy Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | Percent of resistant isolates | Day 0 and Day 42 |
|
Day 0 to Day 42
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infected Patients | Infected Patients |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
Limited source documents.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Withdrawal by Subject |
|
| Subsequent infection |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | Posted | Number | Percent of resistant isolates | Day 0, Day 42 |
|
|
|
| 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 | Posted | Number | Percent of resistant isolates | Day 0, Day 42 |
|
|
|
| 0 |
| 105 |
| 6 |
| 105 |
| EG001 | Healthy Subjects | Healthy Subjects | 0 | 57 | 0 | 57 |
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| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |