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

This study has been completed.
Information provided by:
Center For Excellence In Eye Care Identifier:
First received: May 4, 2007
Last updated: September 23, 2008
Last verified: September 2008
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.

Condition Intervention Phase
Cystoid Macular Edema,
Retinal Thickening
Drug: 2. Xibrom (Bromfenac)
Drug: 1. Pred Forte
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Center For Excellence In Eye Care:

Primary Outcome Measures:
  • Cystoid Macular Edema [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retinal Thickening [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: May 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: 1. Pred Forte

Group 1 Instill one drop in the eye that was operated on four times a day starting on day of surgery and use for four weeks.

Group 2 Instill one drop in the eye that was operated on twice a day starting on day of surgery and use for four weeks.

2 Drug: 2. Xibrom (Bromfenac)
Group 1 and 2: 1 drop(Instill one drop in the eye that was operated on twice daily)3 days prior to surgery and 4 doses during dilation immediately before the procedure. Use for 4 weeks after surgery.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00469781

United States, Florida
The Center for Excellence in Eye Care
Miami, Florida, United States, 33176
Sponsors and Collaborators
Center For Excellence In Eye Care
Principal Investigator: Carlos Buznego, MD The Center for Excellence in Eye Care
  More Information

Responsible Party: Carlos Buznego, MD, The Center for Excellence in Eye Care Identifier: NCT00469781     History of Changes
Other Study ID Numbers: 5306 
Study First Received: May 4, 2007
Last Updated: September 23, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016