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Yufei Tu, Boschert Boschert, Joseph Schwab, Rudolph Wagner, Patrick DeRespinis, suqin guo; Management of Congenital Nasolacrimal Duct Obstruction with Infection in Infants using Besifloxacin-A Prospective Study . Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4870.
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There is no standard of choice of antibiotics for the treatment of congenital nasolacrimal duct obstruction (NLDO) with infection among children under-1-year. This study analyzes the efficacy and safety of a fourth-generation fluoroquinolone, Besifloxacin (Besivance) and compares Besivance with Trimethoprim/ /polymyxin (Polytrim) in the treatment of NLDO with infection.
Twenty-four children under 1-year old with a diagnosis of congenital NLDO with infection were randomized to receive either Besivance or Polytrim (3 times a day for 10 days). A NLDO severity scale based on a standard set of photos, with grades ranging from 0 (no infection) to +4 (severe infection) was developed prior to subject enrollment. NLDO severity scores were evaluated for each subject by treating physician at baseline, 2-, 8- and 16-week visits. The primary outcome measure was a change in NLDO grading score from baseline to 8-week visit. Treatment success was defined as a score of zero after baseline visit or score improvement of 2 or more from the prior visit.
The average age at baseline was 4.5 months. Four subjects were excluded from data analysis (three were lost to follow-up and one was withdrawn by PI). At baseline, the mean NLDO score of Polytrim group (3.0, SD=0.89) was higher than Besivance group (2.44, SD=0.88), indicating worse NLDO in Polytrim group. To adjust for this, the weighted mean change in NLDO scores from baseline to 8-week visit was compared. There was no statistically significant difference in the mean weighted NLDO score (P=0.27) by group (Besivance weighted mean=0.81 (SD=0.39) vs. Polytrim weighted mean= 0.95 (SD=0.12)). Eight (8/9, 88%) Besivance subjects, and ten (10/11, 91%) Polytrim subjects were treated successfully. One (1/9, 11%) Besivance subject, and one (1/11, 9%) Polytrim subject suffered recurrence. No serious adverse events were reported in either group.
Compared to Polytrim, Besivance is as effective and safe in treating NLDO with infection in children less than 1 year of age. Because Besivance is formulated in the DuraSite vehicle allowing higher concentration and prolonged contact time on the eye, less frequent dosing is needed hence better compliance in this young patient population.
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