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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

Primary Purpose

Cystoid Macular Edema,, Retinal Thickening

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
2. Xibrom (Bromfenac)
1. Pred Forte
Sponsored by
Center For Excellence In Eye Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cystoid Macular Edema,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Center for Excellence in Eye Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Cystoid Macular Edema

Secondary Outcome Measures

Retinal Thickening

Full Information

First Posted
May 4, 2007
Last Updated
September 23, 2008
Sponsor
Center For Excellence In Eye Care
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1. Study Identification

Unique Protocol Identification Number
NCT00469781
Brief Title
Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Center For Excellence In Eye Care

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystoid Macular Edema,, Retinal Thickening

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
2. Xibrom (Bromfenac)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
1. Pred Forte
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cystoid Macular Edema
Time Frame
11 months
Secondary Outcome Measure Information:
Title
Retinal Thickening
Time Frame
11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Buznego, MD
Organizational Affiliation
The Center for Excellence in Eye Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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