A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification
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ClinicalTrials.gov Identifier: NCT01001806 |
Recruitment Status :
Completed
First Posted : October 27, 2009
Results First Posted : August 26, 2011
Last Update Posted : October 3, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cataracts | Drug: Ketorolac Tromethamine 0.45% Drug: bromfenac 0.09% Drug: nepafenac 0.1% | 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 Peak Aqueous Penetration 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: Acuvail
Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery
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Drug: Ketorolac Tromethamine 0.45%
One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery
Other Name: Acuvail |
Active Comparator: Xibrom
Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery
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Drug: bromfenac 0.09%
One day pre operative 1 drop BID then 3 doses pre op day of surgery
Other Name: Xibrom |
Active Comparator: Nevanac
One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery
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Drug: nepafenac 0.1%
One drop BID, 1 day pre operative and then 3 doses the day of surgery
Other Name: Nevanac |
- Peak Aqueous Penetration [ Time Frame: day 4 of treatment ]

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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.
- Subject 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 no previous eye surgery, with the exception of refractive surgery, but not within 6 months.
- No ocular use of prostaglandins within 2 weeks of surgery.
- Use of oral, injectable or topical ophthalmic steroids, nonsteroidal anti-inflammatory (NSAIDS) or immunosuppressants within 14 days prior to surgery.
- Contraindications to 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): NCT01001806
United States, Pennsylvania | |
Bucci Laser Vision Institute | |
Wilkes-Barre, Pennsylvania, United States, 18702 |
Principal Investigator: | Frank A Bucci, Jr.,, MD | Bucci Laser Vision Institute |
Responsible Party: | Frank A. Bucci, Jr., M.D., Medical Director, Bucci Laser Vision Institute |
ClinicalTrials.gov Identifier: | NCT01001806 |
Other Study ID Numbers: |
2009-0199 |
First Posted: | October 27, 2009 Key Record Dates |
Results First Posted: | August 26, 2011 |
Last Update Posted: | October 3, 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 |