Prospective Clinical Evaluation of 1.5% Levofloxacin Ophthalmic Solution in Ophthalmic Perioperative Disinfection

Abstract

Gram-positive cocci and Propionibacterium acnes are widely reported agents of infectious postoperative endophthalmitis. This multicenter study was conducted to evaluate the eradication effectiveness and safety profile of levofloxacin 1.5% ophthalmic solution (LVFX 1.5%) for use in perioperative disinfection. Patients who were scheduled for cataract surgery were enrolled. The perioperative regimen of LVFX 1.5% was administered 3 times daily as follows: preoperative 3 days; the day of surgery (in the morning, 1 h before surgery, and immediately after surgery); and postoperative 2 weeks. Conjunctival sac scrapings were collected 3 times in the observation period; before preoperative administration, before iodine eyewash on the day of surgery, and after completion of postoperative administration. Isolated and identified microbial strains were assessed for antibacterial susceptibility. One hundred patients were enrolled and data obtained from 96 patients (mean age, 72.7 ± 8.9 years). The preoperative eradication rate was 86.7% in total microbes. In the case of gram-positive cocci, the preoperative eradication rate was 100%, even though there were LVFX-registrant methicillin-resistant Staphylococcus aureus and methicillin-resistant coagulase-negative Staphylococcus, which had a high minimum inhibitory concentration against LVFX, such as 32 μg/mL. On the other hand, that of P. acnes was 78.3%. No acquired drug resistance was suspected in all strains. Adverse drug reactions occurred in 4.2% patients, and all were slight. For ophthalmic perioperative disinfection, the LVFX 1.5% ophthalmic solution showed a good safety profile, and critical eradication of gram-positive cocci, including the fluoroquinolone-resistant strains.