Evaluation of moxifloxacin 0.5% in treatment of nonperforated bacterial corneal ulcers: a randomized controlled trial.

PURPOSE: To compare the equivalence of moxifloxacin 0.5% with a combination of fortified cefazolin sodium 5% and tobramycin sulfate 1.3% eye drops in the treatment of moderate bacterial corneal ulcers. DESIGN: Randomized, controlled, equivalence clinical trial. PARTICIPANTS AND CONTROLS: Microbiologically proven cases of bacterial corneal ulcers were enrolled in the study and were allocated randomly to 1 of the 2 treatment groups. INTERVENTION: Group A was given combination therapy (fortified cefazolin sodium 5% and tobramycin sulfate) and group B was given monotherapy (moxifloxacin 0.5%). MAIN OUTCOME MEASURES: The primary outcome variable for the study was percentage of the ulcers healed at 3 months. The secondary outcome variables were best-corrected visual acuity and resolution of infiltrates. RESULTS: Of a total of 224 patients with bacterial keratitis, 114 patients were randomized to group A, whereas 110 patients were randomized to group B. The mean ± standard deviation ulcer size in groups A and B were 4.2 ± 2 and 4.41 ± 1.5 mm, respectively. The prevalence of coagulase-negative Staphylococcus (40.9% in group A and 48.2% in group B) was similar in both the study groups. A complete resolution of keratitis and healing of ulcers occurred in 90 patients (81.8%) in group A and 88 patients (81.4%) in group B at 3 months. The observed percentage of healing at 3 months was less than the equivalence margin of 20%. Worsening of ulcer was seen in 18.2% cases in group A and in 18.5% cases in group B. Mean time to epithelialization was similar, and there was no significant difference in the 2 groups (P = 0.065). No serious events attributable to therapy were reported. CONCLUSIONS: Corneal healing using 0.5% moxifloxacin monotherapy is equivalent to that of combination therapy using fortified cefazolin and tobramycin in the treatment of moderate bacterial corneal ulcers. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

In vitro susceptibility of bacterial keratitis isolates to fourth-generation fluoroquinolones.

PURPOSE: To study the microbiological profile of bacterial keratitis in Northern India and to determine the antibiotic sensitivity pattern of bacterial keratitis isolates to fourth-generation fluoroquinolones. METHODS: Laboratory records of all consecutive cases of clinically suspected bacterial corneal ulcers were retrospectively reviewed. Data noted included microorganism isolated and antibiotic culture sensitivity to cefazolin, tobramycin, gatifloxacin, and moxifloxacin. In vitro susceptibility toward individual antibiotics was determined and compared with the potential in vitro susceptibilities to cefazolin-tobramycin, cefazolin-gatifloxacin, and cefazolin-moxifloxacin combinations. RESULTS: A total of 292 bacterial isolates were identified. Of these, 255 (87.3%) were Gram-positive and 37 (12.7%) were Gram-negative. Staphylococcus epidermidis (n=227, 77.7%) was the most common organism. Overall susceptibility of isolates was 95.52% to gatifloxacin, 92.83% to moxifloxacin, 90.07% to tobramycin, and 83.56% to cefazolin (p<0.000). Organisms which showed resistance to fourth-generation fluoroquinolones included Staphylococcus epidermidis, Pseudomonas aeruginosa, viridans streptococci, Streptococcus pneumoniae, Staphylococcus aureus, and Escherichia coli. Susceptibilities to gatifloxacin and moxifloxacin were comparable with each other (p=0.312) and with potential susceptibilities to cefazolin-tobramycin (p=0.479), gatifloxacin-cefazolin (p=0.134), and moxifloxacin-cefazolin (p=0.412) combinations. CONCLUSIONS: Monotherapy with moxifloxacin or gatifloxacin can be an effective alternative to cefazolin-tobramycin combination as a first-line empirical therapy for bacterial keratitis. The addition of cefazolin to a fourth-generation fluoroquinolone is of limited value.