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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cataracts

Intervention / Treatment
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* Drug: Bromfenac
* Drug: Moxifloxacin hydrochloride
* Drug: Prednisolone Acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Moxifloxacin | Drug: Moxifloxacin hydrochloride<br>* Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.<br>* Other names: Moxifloxacin hydrochloride (Vigamox);|
| Placebo Comparator: 3<br>Prednisolone Acetate | Drug: Prednisolone Acetate<br>* Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD).<br>* Other names: Omni-Pred;|
| Active Comparator: 1<br>Bromfenac | Drug: Bromfenac<br>* Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks<br>* Other names: Bromfenac (Xibrom);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT with macular thickening |  | 3-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CME |  | 3-6 weeks |