A MULTICENTER COMPARISON OF THE OCULAR EFFICACY AND SAFETY OF DICLOFENAC 0.1-PERCENT SOLUTION WITH THAT OF KETOROLAC 0.5-PERCENT SOLUTION IN PATIENTS WITH ACUTE SEASONAL ALLERGIC CONJUNCTIVITIS

Only one of several available ophthalmic nonsteroidal anti-inflammator y drugs (NSAIDs) is currently FDA approved for use in acute seasonal a llergic conjunctivitis (SAC). Sixty patients with SAC and moderate itc hing 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 dro p four times daily while awake for 14 days. Ocular signs and symptoms were evaluated at one and two weeks. The primary efficacy variables we re itching and bulbar conjunctival injection. For both treatments, the ocular allergy sign and symptom scores were comparable at baseline. B oth treatments evaluated in this study were well tolerated. Significan t clinical and statistical reductions from baseline were observed in t he primary efficacy variables. Treatment group differences were observ ed for the pain/soreness score with an advantage observed for the DS g roup at 30 minutes and at day 7. Our conclusion is that diclofenac sod ium and ketorolac tromethamine acted similarly to reduce the ocular si gns and symptoms associated with acute seasonal allergic conjunctiviti s. 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 (2 0.7% vs. 3.2%).