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

Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758199
• Other study ID #: 2008-0036
• Status: Completed
• Phase: Phase 4
• First received: September 22, 2008
• Last updated: March 14, 2012
• Start date: July 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2012
• Source: Bp Consulting, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female >18 years of age scheduled to undergo bilateral cataract surgery

• Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)

• Expected visual outcome of BCVA > [greater than or equal to] 20/30 postoperatively

• Ability to provide informed consent, take study medications as directed, and likely to complete all study visits

Exclusion Criteria:

• Known contraindication to any study medication or any of their components

• Required use of ocular medications other than the study medications during the study

• Significant AMD, epi-retinal membrane, retinal vein occlusion, diabetic macular edema, or any macular disease predisposing them to cystoid macular edema.

• Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome

• Anticipated need for mechanical iris dilating devices

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Drug:
• Bromfenac
Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks
• Moxifloxacin hydrochloride
Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.
• 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).

Locations

Country	Name	City	State
United States	Altos Eye Physicians	Los Altos	California

Sponsors (1)

Lead Sponsor	Collaborator
Bp Consulting, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCT with macular thickening		3-6 weeks	No
Secondary	Incidence of CME		3-6 weeks	No