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

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

Status and phase: Completed; Phase 4

Conditions: Cataracts

Treatments: Drug: nepafenac 0.1%; Drug: Ketorolac Tromethamine 0.45%; Drug: bromfenac 0.09%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01001806

2009-0199

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 3 patient groups

Acuvail

Active Comparator group

Description:

Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery

Treatment:

Drug: Ketorolac Tromethamine 0.45%

Xibrom

Active Comparator group

Description:

Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery

Treatment:

Drug: bromfenac 0.09%

Nevanac

Active Comparator group

Description:

One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery

Treatment:

Drug: nepafenac 0.1%