Aim: A multicentre, randomized, placebo-controlled double-masked study was conducted to assess the efficacy and safety of Rimexolone 1% eye drops in reducing inflammation after cataract surgery and intra-ocular lens implantation.
Methods: Rimexolone 1% (124 patients) or placebo (58 patients) was given, four times a day for 14 days starting 22-34 hours after surgery. All patients also received tobramycin 0.3% four times a day for 7 days. The clinical signs of ocular inflammation were recorded on days 1, 3, 8, 15 and 17 or 18.
Results: Rimexolone 1% markedly decreased the mean inflammation severity scores, and the sum of clinical assessments of cells and flare in the anterior chamber compared with placebo at each assessment. In addition, the percentage of patients with no anterior chamber inflammation was significantly higher with Rimexolone 1% than with the placebo at each assessment. All these results were statistically significant. Intra-ocular pressure did not rise after treatment with Rimexolone 1%.
Conclusions: The results suggest that Rimexolone 1% ophthalmic solution is an effective and safe steroidal anti-inflammatory agent for topical use following cataract surgery and intra-ocular lens implantation.