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

2014-07-23 21:12:18 | BioPortfolio

Summary

Approximately 120 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.

Study Design

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

Conditions

Cataracts

Intervention

Ketorolac Tromethamine 0.45%, bromfenac 0.09%, nepafenac 0.1%

Location

Bucci Laser Vision Institute
Wilkes-Barre
Pennsylvania
United States
18702

Status

Recruiting

Source

Bucci Laser Vision Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:18-0400

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