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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 22, 2008
Last Updated Date	March 14, 2012
Start Date ^ICMJE	July 2008
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 24, 2008)	OCT with macular thickening [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00758199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 24, 2008)	Incidence of CME [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
Official Title ^ICMJE	Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Cataracts
Intervention ^ICMJE	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
Study Arm (s)	Active Comparator: 2 Moxifloxacin Intervention: Drug: Moxifloxacin hydrochloride Placebo Comparator: 3 Prednisolone Acetate Intervention: Drug: Prednisolone Acetate Active Comparator: 1 Bromfenac Intervention: Drug: Bromfenac
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	49
Completion Date	January 2010
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00758199
Other Study ID Numbers ^ICMJE	2008-0036
Has Data Monitoring Committee	No
Responsible Party	Bp Consulting, Inc
Study Sponsor ^ICMJE	Bp Consulting, Inc
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bp Consulting, Inc
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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