PURPOSE: To compare the equivalence of @entity7046 0.3% with a combination of fortified @entity7048 5% and @entity2890 1.3% eye drops in the treatment of nonperforated @entity3283 . METHODS: In randomized, controlled, equivalence clinical trials, microbiologically proven cases of nonperforated @entity3283 were enrolled and were allocated randomly to one of the 2 treatment groups. Group A was given combination therapy (fortified @entity7048 5% and @entity2890 1.3%) and group B was given monotherapy ( @entity7046 0.3%). The primary outcome measure was the percentage of corneal ulcers that healed at 3 months of follow-up. RESULTS: Out of 204 @entity1 enrolled, 103 @entity1 were randomized to group A, whereas 101 @entity1 were randomized to group B. The mean    SD of @entity1066 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 @entity1066 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 @entity7046 monotherapy was equivalent to combination therapy with @entity7048 and @entity2890 for the treatment of nonperforated @entity3283 .

@entity7046 0.3% Versus Fortified @entity2890 - XXXX in Treating Nonperforated @entity3283 .

@entity1 :: ('9606', 'Species') :: ['patients'] @entity7046 :: ('MESH:C078049', 'Chemical') :: ['gatifloxacin'] @entity7048 :: ('MESH:D002437', 'Chemical') :: ['cefazolin sodium', 'cefazolin'] @entity2890 :: ('MESH:D014031', 'Chemical') :: ['tobramycin', 'tobramycin sulfate'] @entity1066 :: ('MESH:D014456', 'Disease') :: ['ulcer'] @entity3283 :: ('MESH:D003320', 'Disease') :: ['bacterial corneal ulcers']
@entity7048 :: (MESH:D002437,Chemical) :: ['Cefazolin']
