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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00469781
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : September 25, 2008
Sponsor:
Information provided by:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Study Start Date : May 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Cystoid Macular Edema [ Time Frame: 11 months ]

Secondary Outcome Measures :
  1. Retinal Thickening [ Time Frame: 11 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469781


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

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Responsible Party: Carlos Buznego, MD, The Center for Excellence in Eye Care
ClinicalTrials.gov Identifier: NCT00469781    
Other Study ID Numbers: 5306
First Posted: May 7, 2007    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: September 2008
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bromfenac
Prednisolone acetate
Anti-Inflammatory Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents