Phase 4
N=126
A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification
Cataracts
Bottom Line
View on ClinicalTrials.gov: NCT01001806 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Peak Aqueous Penetration — 688.87; 67.64; 447.1 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketorolac Tromethamine 0.45% (Drug); bromfenac 0.09% (Drug); nepafenac 0.1% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Frank A. Bucci, Jr., M.D.
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Aqueous Penetration |
688.87; 67.64; 447.1 | — |
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 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01001806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.