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

Bp Consulting

Status and phase: Completed; Phase 4

Conditions: Cataracts

Treatments: Drug: Prednisolone Acetate; Drug: Bromfenac; Drug: Moxifloxacin hydrochloride

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00758199

2008-0036

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 3 patient groups, including a placebo group

2

Active Comparator group

Description:

Moxifloxacin

Treatment:

Drug: Moxifloxacin hydrochloride

3

Placebo Comparator group

Description:

Prednisolone Acetate

Treatment:

Drug: Prednisolone Acetate

1

Active Comparator group

Description:

Bromfenac

Treatment:

Drug: Bromfenac