Comparison of Besifloxacin and Polymyxin–Trimethoprim in Treating Congenital Nasolacrimal Duct Obstruction With Infection in Children
Purpose
To compare the efficacy and safety of Besifloxacin (Besivance), a newer quinolone, with Trimethoprim/polymyxin (Polytrim) in treating congenital nasolacrimal duct obstruction (NLDO) with infection in children less than 1 year old.
Methods
This is a prospective, double-masked, parallel-group, randomized study. Twenty-four subjects who were diagnosed with congenital NLDO with infection at age of 1 to 12 months were randomized (1:1 ratio) to receive either Besivance, or Polytrim. The physician-rated score of NLDO, based on preset standard photographs, with a range of 0 (no infection) to +4 (severe infection), was recorded at baseline, 2-, 8- and 16 -week visits. The primary outcome measure is the change from baseline on the physician-rated scale of NLDO with infection to 8-week visit or at the time of treatment failure, if earlier.
Results
Treatment was successful, defined as a grade of 0 or grading scale improves of 2 or more since the prior visit, in 88% Besivance subjects (8/9), and 91% of Polytrim subjects (10/11). Recurrence occurred in one Besivance subject (11%), and one Polytrim subject (9%). The weighted mean change in physician-rated grading scale from baseline to 8-week visit was compared which in Besivance group was 0.81 (SD=0.39) compared to 0.95 (SD=0.12) in Polytrim group (P=0.27, no statistically significance). No adverse event occurred in either group.
Conclusion
Besivance is as effective and safe as Polytrim in treating NLDO with infection in children less than one year old. Besivance has the advantages of being more effective against community-acquired MRSA and requires less frequent dosing with better patient compliance.