Bacterial Conjunctivitis Clinical Trial
Official title:
Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora
Verified date | February 2010 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora
Status | Completed |
Enrollment | 137 |
Est. completion date | June 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 13 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind
Country | Name | City | State |
---|---|---|---|
United States | Multiple Locations | Fort Worth | Texas |
Lead Sponsor | Collaborator |
---|---|
Alcon Research | Tufts University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 |
Day 0 and Day 42 | Yes |
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 |
Day 0, Day 42 | Yes |
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 |
Day 0, Day 42 | Yes |
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