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A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification

Information source: Bucci Laser Vision Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataracts

Intervention: Ketorolac Tromethamine 0.45% (Drug); bromfenac 0.09% (Drug); nepafenac 0.1% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Frank A. Bucci, Jr., M.D.

Official(s) and/or principal investigator(s):
Frank A Bucci, Jr.,, MD, Principal Investigator, Affiliation: Bucci Laser Vision Institute

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.

Clinical Details

Official title: A Comparison of Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Patients Undergoing Phacoemulsification

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Peak Aqueous Penetration

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Bucci Laser Vision Institute, Wilkes-Barre, Pennsylvania 18702, United States
Additional Information

Starting date: October 2009
Last updated: August 26, 2011

Page last updated: August 23, 2015

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