A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
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ClinicalTrials.gov Identifier: NCT01021761 |
Recruitment Status :
Completed
First Posted : November 30, 2009
Results First Posted : August 26, 2011
Last Update Posted : August 31, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cataracts | Drug: Ketorolac Tromethamine Drug: Bromfenac Drug: nepafenac | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 126 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | January 2010 |

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
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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 Name: Xibrom |
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
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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 Name: Nevanac |
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.
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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 Name: Acuvail |
- Aqueous PGE2 Inhibition [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021761
Principal Investigator: | Frank A Bucci, Jr., MD | Bucci Laser Vision |
Responsible Party: | Frank A. Bucci, Jr., M.D., Medical Director, Bucci Laser Vision Institute |
ClinicalTrials.gov Identifier: | NCT01021761 |
Other Study ID Numbers: |
2009 0199 |
First Posted: | November 30, 2009 Key Record Dates |
Results First Posted: | August 26, 2011 |
Last Update Posted: | August 31, 2011 |
Last Verified: | August 2011 |
Cataract Lens Diseases Eye Diseases Ketorolac Ketorolac Tromethamine Nepafenac Bromfenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |