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Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00698724
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : June 10, 2009
Sponsor:
Information provided by:
Bp Consulting, Inc

Tracking Information
First Submitted Date  ICMJE June 13, 2008
First Posted Date  ICMJE June 17, 2008
Last Update Posted Date June 10, 2009
Study Start Date  ICMJE June 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
OCT [ Time Frame: 2-4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
Visual Acuity [ Time Frame: 2-4 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care
Official Title  ICMJE A Prospective, Randomized Single-Masked Clinical Trial Comparing OCT and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care
Brief Summary To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cataracts
Intervention  ICMJE
  • Drug: Xibrom, and Optive
    Xibrom: two drops a day, three days before surgery and 21 days after surgery. Optive: three times a day for 21 days after surgery.
  • Drug: Xibrom and Pred Forte
    Xibrom: two drops a day, three days before surgery and 21 days after surgery. Pred Forte: three times a day for 21 days after surgery.
Study Arms  ICMJE
  • Active Comparator: 1
    Group 1: Xibrom, Optive
    Intervention: Drug: Xibrom, and Optive
  • Active Comparator: 2
    Group 2: Xibrom, Pred Forte
    Intervention: Drug: Xibrom and Pred Forte
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
Estimated Enrollment  ICMJE
 (submitted: June 16, 2008)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female at least 18 years of age.

    • Expectation of 20/25 best corrected visual acuity (BCVA) post-operatively.
    • Patients should be in good general health and devoid of recognized risk factors for CME.
    • Patients with systemic diseases are eligible only if there were no ocular manifestations of the disease (specifically diabetics without retinopathy)
    • Patients must be likely to provide informed consent, take study medications as directed, and complete all study visits
    • Only one eye of each treated patient may be included in the study

Exclusion Criteria:

  • Any known contraindications to any study medication or their component
  • Presence of uncontrolled systemic disease
  • Required use of other ocular medications during the study

    o Artificial tears may be used

  • Diabetics with any clinically evident or history of retinopathy
  • Individuals with age-related macular changes, epi-retinal membranes, other retino-vascular diseases and/or other macular disorders thought to have a less than 20/25 surgical outcome expectation
  • Abnormal pre-operative OCT (if obtainable)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00698724
Other Study ID Numbers  ICMJE 5359
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Gills, St. Luke's Cataract and Laser Institute
Study Sponsor  ICMJE Bp Consulting, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Gills, MD St. Luke's Cataract and Laser Institute
PRS Account Bp Consulting, Inc
Verification Date June 2009

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