Back to resultsDetermination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
Primary Purpose
Cataracts
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bromfenac
Moxifloxacin hydrochloride
Prednisolone Acetate
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts
Eligibility Criteria
Inclusion Criteria:
- Male or female >18 years of age scheduled to undergo bilateral cataract surgery
- Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
- Expected visual outcome of BCVA > [greater than or equal to] 20/30 postoperatively
- Ability to provide informed consent, take study medications as directed, and likely to complete all study visits
Exclusion Criteria:
- Known contraindication to any study medication or any of their components
- Required use of ocular medications other than the study medications during the study
- Significant AMD, epi-retinal membrane, retinal vein occlusion, diabetic macular edema, or any macular disease predisposing them to cystoid macular edema.
- Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
- Anticipated need for mechanical iris dilating devices
Sites / Locations
- Altos Eye Physicians
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
2
3
1
Arm Description
Moxifloxacin
Prednisolone Acetate
Bromfenac
Outcomes
Primary Outcome Measures
OCT with macular thickening
Secondary Outcome Measures
Incidence of CME
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00758199
Brief Title
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
Official Title
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bp Consulting, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
Moxifloxacin
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Prednisolone Acetate
Arm Title
1
Arm Type
Active Comparator
Arm Description
Bromfenac
Intervention Type
Drug
Intervention Name(s)
Bromfenac
Other Intervention Name(s)
Bromfenac (Xibrom)
Intervention Description
Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin hydrochloride
Other Intervention Name(s)
Moxifloxacin hydrochloride (Vigamox)
Intervention Description
Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate
Other Intervention Name(s)
Omni-Pred
Intervention Description
Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD).
Primary Outcome Measure Information:
Title
OCT with macular thickening
Time Frame
3-6 weeks
Secondary Outcome Measure Information:
Title
Incidence of CME
Time Frame
3-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female >18 years of age scheduled to undergo bilateral cataract surgery
Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
Expected visual outcome of BCVA > [greater than or equal to] 20/30 postoperatively
Ability to provide informed consent, take study medications as directed, and likely to complete all study visits
Exclusion Criteria:
Known contraindication to any study medication or any of their components
Required use of ocular medications other than the study medications during the study
Significant AMD, epi-retinal membrane, retinal vein occlusion, diabetic macular edema, or any macular disease predisposing them to cystoid macular edema.
Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
Anticipated need for mechanical iris dilating devices
Facility Information:
Facility Name
Altos Eye Physicians
City
Los Altos
State/Province
California
ZIP/Postal Code
94024
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
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