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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

NCT01001806 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2011-10-03

Study results available
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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.

Conditions

  • Cataracts

Interventions

DRUG

Ketorolac Tromethamine 0.45%

One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery

DRUG

bromfenac 0.09%

One day pre operative 1 drop BID then 3 doses pre op day of surgery

DRUG

nepafenac 0.1%

One drop BID, 1 day pre operative and then 3 doses the day of surgery

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Frank A. Bucci, Jr., M.D.

    lead OTHER

Principal Investigators

  • Frank A Bucci, Jr.,, MD · Bucci Laser Vision Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001806 on ClinicalTrials.gov