A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Xibrom 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
Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Other Names:
|
Active Comparator: Nevanac 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
drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Other Names:
|
Active Comparator: Acuvail 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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Aqueous PGE2 Inhibition [Day 4 of treatment]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects must be 18 years of age or older
-
Scheduled for cataract surgery by phacoemulsification
-
Subjects must be willing to comply with all study requirements and be willing to give informed consent
Exclusion Criteria:
-
Any subject that has a history of uveitis or active iritis
-
Subject can have o previous eye surgery with the exception of refractive surgery but not within 6 month
-
No ocular use of prostaglandins within 2 weeks of surgery
-
Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery
-
Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
-
Active ocular infection
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Frank A. Bucci, Jr., M.D.
- Allergan
Investigators
- Principal Investigator: Frank A Bucci, Jr., MD, Bucci Laser Vision
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2009 0199
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Xibrom | Nevanac | Acuvail |
---|---|---|---|
Arm/Group Description | Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery. |
Period Title: Overall Study | |||
STARTED | 42 | 42 | 42 |
COMPLETED | 41 | 38 | 42 |
NOT COMPLETED | 1 | 4 | 0 |
Baseline Characteristics
Arm/Group Title | Xibrom | Nevanac | Acuvail | Total |
---|---|---|---|---|
Arm/Group Description | Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery. | Total of all reporting groups |
Overall Participants | 42 | 42 | 42 | 126 |
Age (Count of Participants) | ||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
18
42.9%
|
15
35.7%
|
21
50%
|
54
42.9%
|
>=65 years |
24
57.1%
|
27
64.3%
|
21
50%
|
72
57.1%
|
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
72
(31)
|
74
(29)
|
75
(30)
|
74
(29)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
26
61.9%
|
29
69%
|
26
61.9%
|
81
64.3%
|
Male |
16
38.1%
|
13
31%
|
16
38.1%
|
45
35.7%
|
Region of Enrollment (participants) [Number] | ||||
United States |
42
100%
|
42
100%
|
42
100%
|
126
100%
|
Outcome Measures
Title | Aqueous PGE2 Inhibition |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Protocol specified 126 subjects to be enrolled and analysis was performed per protocol. |
Arm/Group Title | Xibrom | Nevanac | Acuvail |
---|---|---|---|
Arm/Group Description | Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery. |
Measure Participants | 42 | 42 | 42 |
Mean (Standard Deviation) [pg/ml] |
288.7
(226.05)
|
320.4
(205.6)
|
224.8
(164.87)
|
Adverse Events
Time Frame | ||||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Xibrom | Nevanac | Acuvail | |||
Arm/Group Description | Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery | Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery. | |||
All Cause Mortality |
||||||
Xibrom | Nevanac | Acuvail | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
Xibrom | Nevanac | Acuvail | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Xibrom | Nevanac | Acuvail | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Frank A. Bucci, Jr., MD |
---|---|
Organization | Bucci Laser Vision |
Phone | 570-825-5949 |
Buccivision@aol.com |
- 2009 0199