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

Sponsor

Bp Consulting, Inc (Other)

Overall Status

Completed

CT.gov ID

NCT00758199

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Drug: Bromfenac Drug: Moxifloxacin hydrochloride Drug: Prednisolone Acetate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 Moxifloxacin	Drug: Moxifloxacin hydrochloride Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery. Other Names: Moxifloxacin hydrochloride (Vigamox)
Placebo Comparator: 3 Prednisolone Acetate	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). Other Names: Omni-Pred
Active Comparator: 1 Bromfenac	Drug: Bromfenac Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks Other Names: Bromfenac (Xibrom)

Arm

Intervention/Treatment

Active Comparator: 2

Moxifloxacin

Drug: Moxifloxacin hydrochloride

Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.

Other Names:

Moxifloxacin hydrochloride (Vigamox)

Placebo Comparator: 3

Prednisolone Acetate

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).

Other Names:

Omni-Pred

Active Comparator: 1

Bromfenac

Drug: Bromfenac

Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks

Other Names:

Bromfenac (Xibrom)

Outcome Measures

Primary Outcome Measures

OCT with macular thickening [3-6 weeks]

Secondary Outcome Measures

Incidence of CME [3-6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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