A Phase 4 interventional study of Ketorolac Tromethamine and Bromfenac in Cataracts, sponsored by Frank A. Bucci, Jr., M.D.. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-31.
Sponsored by Frank A. Bucci, Jr., M.D. · Phase 4, Interventional, and Treatment
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 126 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Frank A. Bucci, Jr., M.D. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Bromfenac
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
Drug: nepafenac
Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery.
Drug: Ketorolac Tromethamine
ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Also known as: Acuvail
Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Also known as: Xibrom
drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Also known as: Nevanac
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.
Time frame: Day 4 of treatment
| Milestone | Xibrom | Nevanac | Acuvail |
|---|---|---|---|
| Started | 42 | 42 | 42 |
| Completed | 41 | 38 | 42 |
| Not completed | 1 | 4 | 0 |
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.
| pg/ml | Xibrom | Nevanac | Acuvail |
|---|---|---|---|
| Aqueous PGE2 Inhibition | 288.7 ± 226.05 | 320.4 ± 205.6 | 224.8 ± 164.87 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Xibrom | — | 0/42 (0%) | 0/42 (0%) |
| Nevanac | — | 0/42 (0%) | 0/42 (0%) |
| Acuvail | — | 0/42 (0%) | 0/42 (0%) |
| Age, Categorical(Participants) | Xibrom | Nevanac | Acuvail | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 15 | 21 | 54 |
| >=65 years | 24 | 27 | 21 | 72 |
| Age Continuous(years) | Xibrom | Nevanac | Acuvail | Total |
|---|---|---|---|---|
| Mean | 72 ± 31 | 74 ± 29 | 75 ± 30 | 74 ± 29 |
| Sex: Female, Male(Participants) | Xibrom | Nevanac | Acuvail | Total |
|---|---|---|---|---|
| Female | 26 | 29 | 26 | 81 |
| Male | 16 | 13 | 16 | 45 |
| Region of Enrollment(participants) | Xibrom | Nevanac | Acuvail | Total |
|---|---|---|---|---|
| United States | 42 | 42 | 42 | 126 |
No study locations are listed for this record.
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Frank A. Bucci, Jr., M.D.