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

Phase 4

Completed

• Conditions: Cystoid Macular Edema,; Retinal Thickening
• Interventions: Drug: 1. Pred Forte; Drug: 2. Xibrom (Bromfenac)

• Registration Number: NCT00469781
• Lead Sponsor: Center For Excellence In Eye Care

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-04
• Study First Submitted QC: 2007-05-04
• Study First Posted: 2007-05-07
• Status Verified: 2008-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2008-09-23
• Last Update Posted: 2008-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• · 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

Exclusion Criteria

• · 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	1. Pred Forte	-
2	2. Xibrom (Bromfenac)	-

Primary Outcome Measures

Name	Time	Method
Cystoid Macular Edema	11 months

Secondary Outcome Measures

Name	Time	Method
Retinal Thickening	11 months

Trial Locations

Locations (1)

The Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States