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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 0.15cc 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 |
|---|---|---|---|
| Xibrom | Active Comparator | Xibrom to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery |
|
| Nevanac | Active Comparator | Nevanac to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery |
|
| Acuvail | Active Comparator | Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac Tromethamine | Drug | ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aqueous PGE2 Inhibition | A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection. | 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 | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Xibrom | Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery |
| FG001 | Nevanac | Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bromfenac | Drug | Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery |
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| nepafenac | Drug | drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery |
|
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| FG002 | Acuvail | Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Xibrom | Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery |
| BG001 | Nevanac | Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery |
| BG002 | Acuvail | Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Aqueous PGE2 Inhibition | A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection. | Protocol specified 126 subjects to be enrolled and analysis was performed per protocol. | Posted | May 2011 | Mean | Standard Deviation | pg/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 | Xibrom | Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | 0 | 42 | 0 | 42 | ||
| EG001 | Nevanac | Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | 0 | 42 | 0 | 42 | ||
| EG002 | 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 |
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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 |
|---|---|
| D020911 | Ketorolac Tromethamine |
| 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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