Clinical Trial: Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1% TID for Treatment of Ocular Inflammation Associated With Cataract Surgery

Brief Summary: This is a single-center, randomized, investigator-masked, parallel group, and active-comparator controlled study investigating the clinical outcomes for visual acuity and macular thickness after treatment with Bromday (bromfenac ophthalmic solution) 0.09% QD or Nevanac (nepafenac ophthalmic suspension) 0.1% TID in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation.

Detailed Summary: Two topical NSAIDs currently approved for postoperative treatment of pain and inflammation in cataract surgery are bromfenac 0.09% and nepafenac 0.1%. Both purport to treat ocular inflammation by acting as a potent inhibitor of COX-1 and COX-2 enzymes. Clinical studies to date lack clarity on which topical NSAID may be the most efficacious.
Sponsor: Discover Vision Centers

Current Primary Outcome:

  • Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities [ Time Frame: Week 6 ]
    ETDRs visual acuities measured at week 6 following uncomplicated phacoemulsification (phaco). ETDRS charts are a standardized eye chart for visual acuity testing accepted by the National Eye Institute and the Food and Drug Administration. The scale is 30-90 letters with higher numbers signifying improved visual acuities.
  • Summed Ocular Inflammation Score (SOIS) [ Time Frame: Week 6 ]
    An assessment of the cells and flare, signs of inflammation in ocular tissue. SOIS (summed ocular inflammation) = cells in the anterior chamber/1mmx1mm high powered field+flare/1mmx1mm high powered field. The score of the number of cells in the anterior chamber per 1mmx1mm high powered field ranges from 0-4: 0=no cells, 1=1-5 cell, 2=6-15 cells, 3=16-30 cells, 4>=30 cells.Flare scores range from 0-3:(0=none, 1=mild, 2=moderate, 3=severe). Cell+flare are added together (cell score + flare score=SOIS score) for a SOIS score (minimum score=0 and maximal score of 7). Higher numbers would indicate more inflammation.The SOIS scale could range from 0-7 with 0 indicating no cells, no flare and 7 reflecting maximal cell 4(>30 cell/high powered field +3 (severe flare).
  • OCT Retinal Thickness [ Time Frame: Week 6 ]
    Stratus OCT scan retinal thickness/volume tabular output report. An experienced ophthalmic technician obtained two scan patterns. The first was the fast macular thickness using 6 radial line scans through a common central axis (fovea) with a retinal thickness/volume tabular output and a retinal-thickness output report. Central retinal thickness was define

    Original Primary Outcome: Optical Coherence Tomography (OCT) measurements of retinal thickness and volume. [ Time Frame: Week 6 ]

    An assessment of retinal thickness and volume


    Current Secondary Outcome:

    Original Secondary Outcome:

    • Summed ocular inflammation score (SOIS) [ Time Frame: Week 6 ]
      An assessment of the cells and flare, signs of inflammation in ocular tissue
    • ETDRS logMAR Visual Acuity [ Time Frame: Week 6 ]
      An assessment of visual acuity


    Information By: Discover Vision Centers

    Dates:
    Date Received: March 1, 2011
    Date Started: November 2010
    Date Completion:
    Last Updated: August 5, 2013
    Last Verified: August 2013