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| Name | Class |
|---|---|
| Ophthalmology Associates, St Louis | OTHER |
| Bausch & Lomb Incorporated | INDUSTRY |
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The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and tolerance when used prophylactically in subjects undergoing routine cataract surgery.
Subjects will be assigned to receive either Besivance or Vigamox (1:1) to be administered as 1 drop in the study eye 4 times daily starting 3 days prior to cataract surgery and continuing for 7 days post-operatively.
Sixty subjects (30 from Ophthalmology Consultants and 30 from Ophthalmology Associates) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| besivance | Active Comparator | ocular antibiotic |
|
| vigamox | Active Comparator | ocular antibiotic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| besivance | Drug | topical ocular antibiotic, 1 drop in study eye QID starting 3 days prior and for 7 days following cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| corneal health | Endothelial Cell Count (day 7, day 28) Pachymetry (day 7, day 28) Corneal Fluorescein Staining (day 7, day 28) Biomicroscopy (day 1, day 7, day 28) | through day 28 post op |
| Measure | Description | Time Frame |
|---|---|---|
| subject tolerance | reported adverse events | day - 3 through day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ranjan Maholtra, MD | Ophthalmology Associates | Principal Investigator |
| Joseph Gira, MD | Ophthalmology Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States | ||
| Ophthalmology Consultants, Ltd |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 28, 2012 | |
| Reset | Aug 6, 2012 | |
| Release | Aug 6, 2012 | |
| Reset | Sep 5, 2012 | |
| Release | Sep 22, 2017 | |
| Reset | Sep 22, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 28, 2012 | Aug 6, 2012 | |||
| Aug 6, 2012 |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C522124 | besifloxacin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| vigamox | Drug | topical ocular antibiotic, 1 drop in study eye QID for 3 days prior and for 7 days following cataract surgery |
|
|
| St Louis |
| Missouri |
| 63131 |
| United States |
| Sep 5, 2012 |
| Sep 22, 2017 | Sep 22, 2017 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |