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This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Besifloxacin | Experimental | Besifloxacin ophthalmic suspension |
|
| Moxifloxacin | Active Comparator | Vigamox (moxifloxacin ophthalmic solution, 0.5%) |
|
| Gatifloxacin | Active Comparator | Zymar (gatifloxacin ophthalmic solution, 0.3%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Besifloxacin hydrochloride | Drug | Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Aqueous Humor Drug Concentration. | An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation. | Visit 2, 1-14 days following screening visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Donnefeld | Ophthalmic Consultants of Long Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Consultants of Long Island | Rockville Centre | New York | 11570 | United States |
105 subjects were screened at Visit 1 and qualified subjects returned on the day of surgery (Visit 2).
This study was conducted a 6 sites in the US. This was a single dose study with first patient enrollment on 2/2/2009 and last patient visit was 7/9/2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Besifloxacin | Besifloxacin ophthalmic suspension |
| FG001 | Moxifloxacin | Vigamox (moxifloxacin ophthalmic solution, 0.5%) |
| FG002 | Gatifloxacin | Zymar (gatifloxacin ophthalmic solution, 0.3%) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Besifloxacin | Besifloxacin ophthalmic suspension |
| BG001 | Moxifloxacin | Vigamox (moxifloxacin ophthalmic solution, 0.5%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | The Aqueous Humor Drug Concentration. | An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation. | Statistical Analysis of AH Drug Concentration. Modified intent to treat population (mITT). Subjects with non-missing data. | Posted | Mean | Standard Deviation | µg/mL | Visit 2, 1-14 days following screening visit | eyes | Participants |
|
Single ocular administration
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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 | Besifloxacin | Besifloxacin ophthalmic suspension |
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All drug concentrations were significantly below MIC90 values for relevant staphylococcal species.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tuyen Ong, MD | Bausch & Lomb Inc | (973) 360-6389 | tuyen.ong@bausch.com |
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| ID | Term |
|---|---|
| C522124 | besifloxacin |
| D000077266 | Moxifloxacin |
| D000077734 | Gatifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| moxifloxacin hydrochloride | Drug | Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. |
|
|
| gatifloxacin | Drug | Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. |
|
|
| BG002 | Gatifloxacin | Zymar (gatifloxacin ophthalmic solution, 0.3%) |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG002 |
| Gatifloxacin |
Zymar (gatifloxacin ophthalmic solution, 0.3%) |
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Moxifloxacin | Vigamox (moxifloxacin ophthalmic solution, 0.5%) | 0 | 35 | 0 | 35 |
| EG002 | Gatifloxacin | Zymar (gatifloxacin ophthalmic solution, 0.3%) | 0 | 36 | 0 | 36 |
All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |