A Multicenter Comparison of the Ocular Efficacy and Safety of Diclofenac 0.1% Solution with that of Ketorolac 0.5% Solution in Patients with Acute Seasonal Allergic Conjunctivitis

Authors:
  • MRMichael B. Raizman
    Michael B. Raizman
  • COCharles S. Ostrov
    Charles S. Ostrov
  • RLRobert A. Laibovitz
    Robert A. Laibovitz
  • MAMark B. Abelson
    Mark B. Abelson
  • JBJ. Gordon Betts
    J. Gordon Betts
  • JKJohn M. Koester
    John M. Koester
  • DGDiane Gill
    Diane Gill
  • LSLynn Schaich
    Lynn Schaich
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Abstract
Only one of several available ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) is currently FDA approved for use in acute seasonal allergic conjunctivitis (SAC). Sixty patients with SAC and moderate itching and bulbar conjunctival injection were enrolled in a multicenter, randomized, double-masked, parallel-group trial comparing diclofenac sodium (DS) with ketorolac tromethamine (KT). Patients instilled 1 drop four times daily while awake for 14 days. Ocular signs and symptoms were evaluated at one and two weeks. The primary efficacy variables were itching and bulbar conjunctival injection. For both treatments, the ocular allergy sign and symptom scores were comparable at baseline. Both treatments evaluated in this study were well tolerated. Significant clinical and statistical reductions from baseline were observed in the primary efficacy variables. Treatment group differences were observed for the pain / soreness score with an advantage observed for the DS group at 30 minutes and at day 7. Our conclusion is that diclofenac sodium and ketorolac tromethamine acted similarly to reduce the ocular signs and symptoms associated with acute seasonal allergic conjunctivitis. There was a statistically significant advantage for the DS group to be free of symptoms at the day 7 visit as compared to the KT group (20.7% vs. 3.2%).

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