Gatifloxacin 0.3% Versus Fortified Tobramycin-Cefazolin in Treating Nonperforated Bacterial Corneal Ulcers: Randomized, Controlled Trial.

PURPOSE: To compare the equivalence of gatifloxacin 0.3% with a combination of fortified cefazolin sodium 5% and tobramycin sulfate 1.3% eye drops in the treatment of nonperforated bacterial corneal ulcers.

METHODS: In randomized, controlled, equivalence clinical trials, microbiologically proven cases of nonperforated bacterial corneal ulcers were enrolled and were allocated randomly to one of the 2 treatment groups. Group A was given combination therapy (fortified cefazolin sodium 5% and tobramycin sulfate 1.3%) and group B was given monotherapy (gatifloxacin 0.3%). The primary outcome measure was the percentage of corneal ulcers that healed at 3 months of follow-up.

RESULTS: Out of 204 patients enrolled, 103 patients were randomized to group A, whereas 101 patients were randomized to group B. The mean ± SD of ulcer size in groups A and B were 4.35 ± 1.36 and 4.18 ± 1.31 mm, respectively (P = 0.376). The most common bacterial isolate was coagulase-negative Staphylococcus (51.5% in group A and 45.5% in group B). Worsening of the ulcer was seen in 27.2% (28/103) of the cases in group A and in 21.8% (22/101) of the cases in group B. The percentage healing difference was calculated to be 5.4% (90% confidence interval, -4.5 to 15.3). No serious events attributable to therapy were reported in any group.

CONCLUSIONS: Using the prespecified definition of equivalence of ±20%, this trial found evidence that gatifloxacin monotherapy was equivalent to combination therapy with cefazolin and tobramycin for the treatment of nonperforated bacterial corneal ulcers.