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M Santocono, S Russo, P Russo, A Di Bella, V Papa, G Milazzo; Efficacy and Safety of 0.2% Naproxen Ophthalmic Solution in Reducing Postoperative Inflammation After Cataract Surgery . Invest. Ophthalmol. Vis. Sci. 2002;43(13):378.
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Purpose:To compare the efficacy and safety of 0.2% naproxen with that of 0.1% diclofenac ophthalmic solutions in the control and treatment of anterior chamber cells and flare reaction in patients having cataract surgery with intraocular lens implantation. Methods: Randomized, double-masked, active-controlled, parallel-group, multicenter study. After informed consent, 222 patients undergoing phacoemulsification and fulfilling the criteria for study entry were randomly treated with either 0.2% naproxen or 0.1% diclofenac 3 times daily for 30 days starting the day before surgery. Post-surgical ocular inflammation was measured after 1, 10 and 30 days by using slit-lamp biomicroscope and assigning a score according to a validate categorical scale. Safety parameters were also evaluated at the same time. Results: At the primary endpoint (Day 10), the percentage change from Baseline at Day 1 of the anterior chamber inflammation – i.e. sum of anterior chamber cells and flare - (primary efficacy parameter) resulted equivalent between the two groups of treatment with a value of 33.45% in the naproxen group and of 33.82% in the diclofenac group (p=0.8119). For all secondary efficacy parameters, there were no statistically significant treatment differences at Day 1, Day 10 and Day 30. Moreover, both treatments were shown to be safe and well tolerated. Conclusion: The overall results show that 0.2% naproxen ophthalmic solution was as therapeutically effective and safe as diclofenac in the control and treatment of post-surgical ocular inflammation.
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