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.
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.
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.
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.