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 | Completed Phase 4 Results

• 1 other identifier: 2009-0199
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Peak Aqueous Penetration

  day 4 of treatment

Study Arms (3)

Acuvail

ACTIVE COMPARATOR

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

Drug: Ketorolac Tromethamine 0.45%

Xibrom

ACTIVE COMPARATOR

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

Drug: bromfenac 0.09%

Nevanac

ACTIVE COMPARATOR

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

Drug: nepafenac 0.1%

Interventions

Ketorolac Tromethamine 0.45% DRUG

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

Also known as: Acuvail

Acuvail

bromfenac 0.09% DRUG

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

Also known as: Xibrom

Xibrom

nepafenac 0.1% DRUG

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

Also known as: Nevanac

Nevanac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Frank A. Bucci, Jr., M.D.: lead
• Allergan: collaborator

Study Sites (1)

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Ketorolac; bromfenac; nepafenac

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Frank A. Bucci, Jr., MD
• Organization: Bucci Laser Vision

Buccivision@aol.com

570-825-5949

Study Officials

• Frank A Bucci, Jr.,, MD

  Bucci Laser Vision Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 27, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: October 3, 2011
• Results First Posted: August 26, 2011

Record last verified: 2011-08

Locations

US (1)