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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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Approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09% BID. Patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. KOWA flare measurements will be performed at postoperative day one and postoperative day 14. The amount of anterior chamber inflammation (flare) will be objectively measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bromfenac 0.09% | Active Comparator | bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days. |
|
| Acuvail | Active Comparator | Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac Tromethamine 0.45% | Drug | Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Inflammation (Flare) | Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber. | Day 14 of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Xibrom | Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days. |
| FG001 | Acuvail | Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bromfenac 0.09% | Drug | Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Xibrom | Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days. |
| BG001 | Acuvail | Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Anterior Chamber Inflammation (Flare) | Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber. | Posted | May 2011 | Mean | Standard Deviation | photon count per msec (pc/ms) | Day 14 of treatment |
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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 | Xibrom | Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days. | 0 | 25 | 0 | 25 | ||
| EG001 | Acuvail | Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days. | 0 | 25 | 0 | 25 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank A. Bucci, Jr., MD | Bucci Laser Visiosn | 570-825-5949 | Buccivision@aol.com |
| >=65 years |
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| Male |
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