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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acuvail | Active Comparator | Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery |
|
| Xibrom | Active Comparator | Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery |
|
| Nevanac | Active Comparator | One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac Tromethamine 0.45% | Drug | One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Aqueous Penetration | day 4 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 | Acuvail | Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery |
| FG001 | Xibrom | Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| bromfenac 0.09% | Drug | One day pre operative 1 drop BID then 3 doses pre op day of surgery |
|
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| nepafenac 0.1% | Drug | One drop BID, 1 day pre operative and then 3 doses the day of surgery |
|
|
| FG002 | Nevanac | One day before surgery 1 drop BID, then 3 doses pre op day of surgery |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Acuvail | Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery |
| BG001 | Xibrom | Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery |
| BG002 | Nevanac | One day before surgery 1 drop BID, then 3 doses pre op day of surgery |
| BG003 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Peak Aqueous Penetration | Protocol specified enrollment of 126 subjects and analysis was performed per protocol. | Posted | May 2011 | Mean | Standard Deviation | ng/ml | day 4 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 | Acuvail | Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery | 0 | 42 | 0 | 42 | ||
| EG001 | Xibrom | Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery | 0 | 42 | 0 | 42 | ||
| EG002 | Nevanac | One day before surgery 1 drop BID, then 3 doses pre op day of surgery | 0 | 42 | 0 | 42 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank A. Bucci, Jr., MD | Bucci Laser Vision | 570-825-5949 | Buccivision@aol.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| C053083 | bromfenac |
| C414203 | nepafenac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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