May 2008
Volume 49, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2008
The Incidence of Macular Edema From Two Integrated Phase III Clinical Trials of Bromfenac Ophthalmic Solution Administered Once Daily for Cataract Surgery
Author Affiliations & Notes
  • T. R. Walters
    Keystone Research Ltd, Austin, Texas
  • Y. R. Chu
    Chu Laser Eye Institute, Edina, Minnesota
  • E. R. Craven
    Glaucoma Consultants of Colorado, Littleton, Colorado
  • L. R. DeBarge
    Advanced Eye Care, P.C., Ft. Oglethorpe, Georgia
  • L. Cacioppo
    Hernando Eye Institute, Brooksville, Florida
  • C. K. Song
    ISTA Pharmaceuticals, Inc., Irvine, California
  • R. Bianca
    ISTA Pharmaceuticals, Inc., Irvine, California
  • J. A. Gow
    ISTA Pharmaceuticals, Inc., Irvine, California
  • T. R. McNamara
    ISTA Pharmaceuticals, Inc., Irvine, California
  • Bromfenac Ophthalmic Solution Once Daily Study Group
    Keystone Research Ltd, Austin, Texas
  • Footnotes
    Commercial Relationships  T.R. Walters, Keystone Research Ltd, F; Y.R. Chu, Chu Laser Eye Institute, F; E.R. Craven, Glaucoma Consultants of Colorado, F; L.R. DeBarge, Advanced Eye Care, P.C., F; L. Cacioppo, Hernando Eye Institute, F; C.K. Song, ISTA Pharmaceuticals, Inc., E; R. Bianca, ISTA Pharmaceuticals, Inc., E; J.A. Gow, ISTA Pharmaceuticals, Inc., E; T.R. McNamara, ISTA Pharmaceuticals, Inc., E.
  • Footnotes
    Support  None.
Investigative Ophthalmology & Visual Science May 2008, Vol.49, 2705. doi:https://doi.org/
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      T. R. Walters, Y. R. Chu, E. R. Craven, L. R. DeBarge, L. Cacioppo, C. K. Song, R. Bianca, J. A. Gow, T. R. McNamara, Bromfenac Ophthalmic Solution Once Daily Study Group; The Incidence of Macular Edema From Two Integrated Phase III Clinical Trials of Bromfenac Ophthalmic Solution Administered Once Daily for Cataract Surgery. Invest. Ophthalmol. Vis. Sci. 2008;49(13):2705. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : To evaluate the incidence of macular edema in a clinical study of bromfenac ophthalmic solution administered once daily for the prevention and treatment of anterior chamber inflammation associated with cataract surgery.

Methods: : Subjects were assigned randomly to receive either bromfenac ophthalmic solution QD (n=354) or placebo QD (n=179). Dosing began 1 day before cataract surgery and continued through post-surgery Day 14. The incidence of macular edema was assessed over the duration of the treatment (16 days) and follow-up (6 days) periods.

Results: : In the bromfenac treatment group, no subject (0%, 0/354) experienced an adverse event reported as macular edema. In the placebo treatment group, 4.5% (8/179) experienced the adverse event of macular edema. The severity of macular edema ranged from mild to severe; 5 subjects had macular edema ongoing at study completion, and in the 3 remaining subjects, the macular edema resolved at study termination.

Conclusions: : Bromfenac ophthalmic solution administered once daily may prevent and treat macular edema associated with cataract extraction surgery.

Clinical Trial: : www.clinicaltrials.gov NCT00333918

Keywords: cataract • macula/fovea • edema 
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