[Comparative research of the efficacy of the gatifloxacin and levofloxacin for bacterial conjunctivitis in human eyes].

Objective: To evaluate the different efficacy and safety to the treatment of bacterial conjunctivitis between the fluoroquinolone antibiotics gatifloxacin and levofloxacin.

Methods: A multi-centre, random, double-blind and control trial was performed in six centers including Eye Ear Nose and Throat Hospital of Fudan University, Henan Eye Institute, Eye Hospital Affiliated to Wenzhou Medical College, the First Affiliated Hospital Of Nanjing Medical University, Xijing Hospital Affiliated to the Fourth Military Medical University, the Second Affiliated Hospital of Xi'an Jiaotong University between August 2006 and October 2007. The levofloxacin was set as the efficient control. Two hundred and thirty-five patients (235 eyes) that diagnosed as bacterial conjunctivitis were randomly divided into two groups by the method of randomized blocks, the test group (gatifloxacin) had 118 eyes and the control (levofloxacin) group had 117 eyes. The drug delivery into conjunctival sac was performed at a 7-day period (two drops per time, eight times per day at the first two days and two drops per time, four times per day at the following 5 days). All participants were given the conjunctival sac germ culture and drug sensitive test before and after the study. The combination score of signs and symptoms and evaluation of safety were conducted at the pre-delivery day, the (4 ± 1) and (7 ± 1) delivery day. The statistic analysis was conducted by CMH χ(2) test, Pearson χ(2) test and Fisher's exact probabilities test.

Results: The efficacy of the two groups was 94.0% (110/117 eyes) in gatifloxacin group and 93.8% (106/113 eyes) in levofloxacin group with no significant difference (χ(2) = 0.052, P = 0.8201). There was also no difference in the bacteria clearance between the two groups [gatifloxacin versus levofloxacin, 94.1% (80/85 eyes) versus 92.5% (74/80 eyes), P = 0.3470]. The decrease of combination score of signs and symptoms at the (4 ± 1) delivery day was 4.436 ± 2.310 in the gatifloxacin group and 3.814 ± 1.962 in the levofloxacin group, the difference of which was significant (F = 7.280, P = 0.0075). This trend was also proved at the (7 ± 1) delivery day (gatifloxacin versus levofloxacin, 7.487 ± 2.821 versus 6.912 ± 2.911, F = 4.060, P = 0.0452). The visual acuity and the tolerance after local application of the eye drops between the two groups had no difference (the visual acuity F = 1.04, P = 0.3080; the tolerance after local admission χ(2) = 0.1372, P = 0.7111). According to the result of the germ culture, the major pathogenic bacteria were Gram-positive bacteria (totally 20 kinds of Gram-positive bacteria and 8 kinds of Gram-negative bacteria). The MIC and drug resistance of gatifloxacin to the Gram-positive bacteria was lower than that of the levofloxacin (Staphylococcus Epidermidis, Staphylococcus Aureus, coagulase negative Staphylococcus, α-hemolytic Streptococcus).

Conclusions: The gatifloxacin eye drop has a good therapeutic effect to the bacterial conjunctivitis. It can effectively clear the pathogen with fast and strong effect. Moreover, it has a low MIC in vitro, advance a prospect in drug resistance, safety and ocular tolerance.