Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening

Completed · Phase 4

Conditions studied: Cystoid Macular Edema,, Retinal Thickening

In brief

The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.

Key facts

Study ID

NCT00469781

Run by

Center For Excellence In Eye Care

People needed

95

Starts

2007-05-01

Expected to finish

2008-09-01

Last updated by the study team

2008-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• · Male or female > 18 years of age scheduled to undergo cataract surgery
• Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
• Expected visual outcome of 20/25 or better.
• Ability to provide informed consent and likely to complete all study visits

You may not qualify if…

• · Known contraindication to any study medication or any of their components
• Uncontrolled systemic disease
• Required use of ocular medications other than the study medications during the study
• Abnormal pre-operative OCTs
• Diabetic patients with a history of macular edema or diabetic retinopathy
• AMD, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease
• Only one eye of each patient can be enrolled

Where it is running

• The Center for Excellence in Eye Care — Miami, Florida, United States

Full record on ClinicalTrials.gov

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