Efficacy and safety of pazufloxacin mesylate eye drops for bacterial conjunctivitis: a multicenter randomized, double-masked, parallel controlled clinical trial

Abstract

Objective To compare the clinical efficacy and safety following the topical application of pazufloxacin mesylate eye drops with levofloxacin eye drops (LOFX) for bacterial conjunctivitis. Methods A multicenter, randomized, investigator-masked, parallel-controlled clinical trial was performed.Five hundred and twenty eyes of 520 patients with bacterial conjunctivitis were enrolled from March to October 2008 in seven ophthalmic centers in China.The patients were randomized into trial group and control group in 3∶1 ratio with the 390 eyes in the trial group and 130 eyes in the control group.Pazufloxacin mesylate eye drops was topically used 4 times per day for consecutively 7-14 days in the trial group, and levofloxacin eye drops was used in the same way in the control group.Microbiological cultures for conjunctiva sac secretions and drug sensitive test were carried out before and at the end of the administration of eye drops.The signs and symptoms were observed and scored before treatment and 0, 3, 7 and 14 days after treatment.The adverse events following the administration of the eye drops were evaluated and compared. Results The intention to treat analysis (ITT) showed that the cure rate was 59.38% in the trial group and 60.47% in the control group, with the effective rate 88.80% and 86.05%, respectively, with an insignificant difference between the two groups (χ2=0.12, P=0.72). The clinically evaluable analysis (CE) exhibited that the cure rates were 63.48% in the trial group and 63.87% in the control group, with the effective rate 92.46% and 88.24%, which was not significantly different between them (χ2=0.54, P=0.46). The modified-ITT analysis (mITT) showed that the cure rates were 60.57% in the trial group and 62.07% in the control group, with the effective rate 90.32% and 88.51%, without significant difference between the two groups (P>0.05). Based on microbiologically evaluable analysis (ME), the clinical cure rates were 63.71% and 63.41% in the trial group and control group, and the effective rates were 93.44% and 90.24%, respectively.There was no significantly difference between the both groups (P>0.05). In the trial group and control group, the bacterial eradication rate was 89.42% and 90.80% based on ITT, 90.11% and 92.77% based on CE, respectively.There was no significant difference in incidences of adverse events following the administration of the drug between the trial group and control group, including ocular tolerance, burning sensation, pricking and itching (P=0.34). Conclusions The effectiveness and adverse response were resemble between Pazufloxacin mesylate eye drops and LOFV following the topical application for bacterial conjunctivitis, which indicate that Pazufloxacin mesylate eye drops is effective and safe. Key words: Pazufloxacin mesylate eye drops; Conjunctivitis, bacterial; Multicenter randomized double-blind controlled clinical trial; Treatment outcome; Safety