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

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

Condition Intervention Phase
Drug: Bromfenac
Drug: Moxifloxacin hydrochloride
Drug: Prednisolone Acetate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery

Resource links provided by NLM:

Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:
  • OCT with macular thickening [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of CME [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: July 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
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)
Placebo Comparator: 3
Prednisolone Acetate
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: 1
Drug: Bromfenac
Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks
Other Name: Bromfenac (Xibrom)


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00758199

United States, California
Altos Eye Physicians
Los Altos, California, United States, 94024
Sponsors and Collaborators
Bp Consulting, Inc
  More Information

Responsible Party: Bp Consulting, Inc Identifier: NCT00758199     History of Changes
Other Study ID Numbers: 2008-0036 
Study First Received: September 22, 2008
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eye Diseases
Lens Diseases
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Norgestimate, ethinyl estradiol drug combination
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Analgesics, Non-Narcotic
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors processed this record on May 26, 2016