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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bp Consulting, Inc
• Treatments: Bromfenac; Fluoroquinolones; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ophthalmic Solutions; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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