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

Phase 4

Completed

• Conditions: Cataracts
• Interventions: Drug: Moxifloxacin hydrochloride; Drug: Bromfenac; Drug: Prednisolone Acetate

• Registration Number: NCT00758199
• Lead Sponsor: Bp Consulting, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Moxifloxacin hydrochloride	Moxifloxacin
1	Bromfenac	Bromfenac
3	Prednisolone Acetate	Prednisolone Acetate

Primary Outcome Measures

Name	Time	Method
OCT with macular thickening	3-6 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of CME	3-6 weeks

Trial Locations

Locations (1)

Altos Eye Physicians; 🇺🇸 Los Altos, California, United States