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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
History of Changes
  Purpose

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
Cataracts
 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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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
Moxifloxacin
 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
Bromfenac
 Drug: Bromfenac
Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks
Other Name: Bromfenac (Xibrom)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758199

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

No publications provided

Responsible Party: Bp Consulting, Inc
ClinicalTrials.gov 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:
Cataract
Lens Diseases
Eye Diseases
Methylprednisolone acetate
Prednisolone acetate
Bromfenac
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal

ClinicalTrials.gov processed this record on May 23, 2013