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Completed

NCT Number: NCT01001806

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

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.

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketorolac Tromethamine 0.45%

Drug

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

Other names: Acuvail

bromfenac 0.09%

Drug

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

Other names: Xibrom

Nepafenac 0.1%

Drug

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

Other names: Nevanac

Primary outcomes

  1. Peak Aqueous Penetration

    Time frame: day 4 of treatment

Sponsors and collaborators

Lead sponsor

Frank A. Bucci, Jr., M.D.

Other

Collaborators

  • Allergan

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Oct 27, 2009
Registry last updated
Oct 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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