A Phase 4 interventional study of VIGAMOX in Bacterial Conjunctivitis, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 1 Year to 13 Years. Per ClinicalTrials.gov, last updated 2012-11-02.
Sponsored by Alcon Research (part of Alcon) · Phase 4 and Interventional
Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 137 is below the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
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Exclusion Criteria:
Conjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days.
Drug: VIGAMOX
Healthy Subjects receiving no treatment
1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days
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
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
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
Study recruitment started in June 2006 and ran until January 29 2008. The study sites included three sites (AZ, CA and IL)
| Milestone | Infected Patients | Healthy Subjects |
|---|---|---|
| Started | 105 | 57 |
| Completed | 83 | 54 |
| Not completed | 22 | 3 |
| Withdrew: Adverse event | 7 | 2 |
| Withdrew: Lost to follow-up | 9 | 1 |
| Withdrew: Withdrawal by subject | 4 | 0 |
| Withdrew: Subsequent infection | 2 | 0 |
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
| Percent of resistant isolates | Infected Patients | Healthy Subjects |
|---|---|---|
| Day 0 | 0 | 0 |
| Day 42 | 0 | 0 |
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
| Percent of resistant isolates | Infected Patients | Healthy Subjects |
|---|---|---|
| Day 0 | 8.3 | 0 |
| Day 42 | 0 | 0 |
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
| Percent of resistant isolates | Infected Patients | Healthy Subjects |
|---|---|---|
| Day 0 | 0 | 0 |
| Day 42 | 0 | 0 |
Collected over Day 0 to Day 42. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infected Patients | — | 0/105 (0%) | 6/105 (5.7%) |
| Healthy Subjects | — | 0/57 (0%) | 0/57 (0%) |
| Event | Infected Patients | Healthy Subjects |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 6/105 | 0/57 |
| Age, Categorical(Participants) | Infected Patients | Healthy Subjects | Total |
|---|---|---|---|
| <=18 years | 105 | 57 | 162 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Infected Patients | Healthy Subjects | Total |
|---|---|---|---|
| Female | 48 | 28 | 76 |
| Male | 57 | 29 | 86 |
The record gives a start of Jun 2006, a primary completion of Jun 2007 and a completion of Jun 2007. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2010, 2 years 8 months after primary completion.
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This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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