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Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bp Consulting, Inc
ClinicalTrials.gov Identifier:
NCT00758199
First received: September 22, 2008
Last updated: March 14, 2012
Last verified: March 2012

September 22, 2008
March 14, 2012
July 2008
January 2010   (final data collection date for primary outcome measure)
OCT with macular thickening [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00758199 on ClinicalTrials.gov Archive Site
Incidence of CME [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Cataracts
  • Drug: Bromfenac
    Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks
    Other Name: Bromfenac (Xibrom)
  • Drug: Moxifloxacin hydrochloride
    Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.
    Other Name: Moxifloxacin hydrochloride (Vigamox)
  • Drug: Prednisolone Acetate
    Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD).
    Other Name: Omni-Pred
  • Active Comparator: 2
    Moxifloxacin
    Intervention: Drug: Moxifloxacin hydrochloride
  • Placebo Comparator: 3
    Prednisolone Acetate
    Intervention: Drug: Prednisolone Acetate
  • Active Comparator: 1
    Bromfenac
    Intervention: Drug: Bromfenac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00758199
2008-0036
No
Bp Consulting, Inc
Bp Consulting, Inc
Not Provided
Not Provided
Bp Consulting, Inc
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP