A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification

Cataracts Clinical Trial

Official title:

A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021761
• Other study ID #: 2009 0199
• Status: Completed
• Phase: Phase 4
• First received: November 25, 2009
• Last updated: August 26, 2011
• Start date: October 2009
• Est. completion date: January 2010

Study information

• Verified date: August 2011
• Source: Bucci Laser Vision Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 0.15cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must be 18 years of age or older

• Scheduled for cataract surgery by phacoemulsification

• Subjects 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 o previous eye surgery with the exception of refractive surgery but not within 6 month

• No ocular use of prostaglandins within 2 weeks of surgery

• Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery

• Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)

• Active ocular infection

Study Design

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

Related Conditions & MeSH terms

• Cataracts

Intervention

Drug:
• Ketorolac Tromethamine
ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
• Bromfenac
Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
• nepafenac
drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Frank A. Bucci, Jr., M.D.	Allergan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aqueous PGE2 Inhibition	A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.	Day 4 of treatment	No