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To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIGAMOX | Active Comparator | Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection |
|
| Besivance | Active Comparator | Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin Ophthalmic | Drug |
| ||
| Besifloxacin Ophthalmic |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days | Lid and Conjunctival cultures will be taken to measure bacterial colonization. | Following 3 days of antibiotic drops topically instilled |
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Inclusion Criteria:
Exclusion Criteria:
Known allergy or contraindication to the test article(s) or their components.
Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
Use of disallowed therapies (systemic or topical):
Use of contact lenses for one week prior to the study and for the duration of the study.
Received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Frank A. Bucci, Jr., MD | Bucci Laser Vision Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucci Laser Vision Institute | Wilkes-Barre | Pennsylvania | 18702 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | VIGAMOX | Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection |
| FG001 | Besivance | Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VIGAMOX | Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection |
| BG001 | Besivance | Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection |
| 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 | Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days | Lid and Conjunctival cultures will be taken to measure bacterial colonization. | Posted | Count of Participants | Participants | Following 3 days of antibiotic drops topically instilled |
|
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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 | VIGAMOX | Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank A. Bucci Jr., MD | Bucci Laser Vision | 570-825-5949 | buccivision@aol.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Besivance | Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection | 0 | 28 | 0 | 28 |
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