NCT00758199

Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Bp Consulting, Inc · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.

Conditions

• Cataracts

Interventions

Type	Name	Description
DRUG	Bromfenac	Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks
DRUG	Moxifloxacin hydrochloride	Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.
DRUG	Prednisolone Acetate	Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD).

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-09-25
• Last updated: 2012-03-15

Locations

1 site across 1 country: United States