May 2008
Volume 49, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2008
Efficacy of Bromfenac Ophthalmic Solution Administered Once Daily for Ocular Inflammation and Pain Associated With Cataract Surgery
Author Affiliations & Notes
  • S. M. Silverstein
    Silverstein Eye Centers, Kansas City, Missouri
  • H. Reiser
    Eye Care Specialist, Kingston, Pennsylvania
  • R. P. Lehmann
    Lehmann Eye Center, Nacogdoches, Texas
  • M. S. Dirks
    Black Hills Eye Institute, Rapid City, South Dakota
  • G. Foster
    Eye Center of Northern Colorado, Ft. Collins, Colorado
  • P. A. Rapoza
    Ophthalmic Consultants of Boston, Boston, Massachusetts
  • R. Bianca
    ISTA Pharmaceuticals, Inc., Irvine, California
  • J. A. Gow
    ISTA Pharmaceuticals, Inc., Irvine, California
  • T. R. McNamara
    ISTA Pharmaceuticals, Inc., Irvine, California
  • for the Bromfenac Ophthalmic Solution Once Daily Study Group
    Silverstein Eye Centers, Kansas City, Missouri
  • Footnotes
    Commercial Relationships  S.M. Silverstein, Silverstein Eye Center, F; H. Reiser, Eye Care Specialist, F; R.P. Lehmann, Lehmann Eye Center, F; M.S. Dirks, Black Hills Eye Institute, F; G. Foster, Eye Center of Northern Colorado, F; P.A. Rapoza, Ophthalmic Consultants of Boston, F; 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, 5678. doi:
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      S. M. Silverstein, H. Reiser, R. P. Lehmann, M. S. Dirks, G. Foster, P. A. Rapoza, R. Bianca, J. A. Gow, T. R. McNamara, for the Bromfenac Ophthalmic Solution Once Daily Study Group; Efficacy of Bromfenac Ophthalmic Solution Administered Once Daily for Ocular Inflammation and Pain Associated With Cataract Surgery. Invest. Ophthalmol. Vis. Sci. 2008;49(13):5678.

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Abstract

Purpose: : To evaluate the efficacy of bromfenac ophthalmic solution administered once daily for treatment of ocular inflammation and pain associated with cataract surgery.

Methods: : Subjects were assigned randomly to receive either bromfenac ophthalmic solution QD (n=360) or placebo QD (n=182). Dosing began 1 day before cataract surgery and continued through post-surgery day 14. Efficacy was assessed by Summed Ocular Inflammation Score (SOIS, sum of anterior chamber cells and flare grading, 11 point scale), anterior chamber cells grading (6 point scale), anterior chamber flare grading (5 point scale), and subjective report of ocular pain (4 point scale).

Results: : The mean SOIS was significantly less in the bromfenac treatment group than in the placebo treatment group at days 1, 3, 8, 15, and 22; the difference was statistically significant and ≥1 unit at days 3, 8, 15, and 22. The mean anterior chamber cells grade was significantly less in the bromfenac treatment group than in the placebo treatment group at days 1, 3, 8, 15, and 22; the difference was statistically significant and >1 unit at days 8, 15, and 22. The mean anterior chamber flare grade was significantly less in the bromfenac treatment group than in the placebo treatment group at days 1, 3, 8, 15, and 22. The mean grade for ocular pain was significantly less in the bromfenac treatment group than in the placebo treatment group; the difference was ≥55% at days 1, 3, 8, and 15.

Conclusions: : Bromfenac ophthalmic solution administered once daily was effective for the treatment of ocular inflammation and pain associated with cataract surgery.

Clinical Trial: : www.clinicaltrials.gov NCT00333918

Keywords: anterior chamber • cataract • inflammation 
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