Abstract
PURPOSE: The aim of this study was to evaluate the safety and efficacy of topical besifloxacin ophthalmic suspension 0.6% compared with gatifloxacin ophthalmic solution 0.3% in the treatment of bacterial conjunctivitis in neonates. METHODS: This was a multicenter, randomized, double-masked, parallel group study. Subjects ≤31 days of age with severity grade ≥1 (scale 0-3) for both conjunctival discharge and conjunctival hyperemia were randomized to besifloxacin or gatifloxacin instilled three times daily for 7 days, and completed five study visits (three clinic visits and two phone calls). Primary endpoints included clinical resolution (absence of both conjunctival discharge and conjunctival hyperemia) at visit 5 (day 8 or 9) and ocular and non-ocular treatment-emergent adverse events (AEs). Bacterial eradication was a secondary endpoint. RESULTS: Thirty-three subjects were included in the intent-to-treat (ITT) population. All were aged <28 days, with a mean (standard deviation) age of 15.5 days (6.0), and 57.6% were female. Twenty-two subjects had culture-confirmed conjunctivitis in at least one eye (modified ITT [mITT] population), most often with Gram-positive bacteria. Visit 5 clinical resolution and bacterial eradication rates were comparable among besifloxacin- and gatifloxacin-treated study eyes (clinical resolution: 12/16 [75.0%] vs. 12/17 [70.6%] for the ITT population, and 11/13 [84.6%] vs. 7/9 [77.8%] for the mITT population; bacterial eradication: 12/13 [92.3%] vs. 8/9 [88.9%] for the mITT population, respectively). No AEs were reported in the besifloxacin treatment group, and AEs reported in the gatifloxacin group were considered not treatment-related. CONCLUSIONS: In this small study in neonates, both besifloxacin and gatifloxacin appeared effective and safe in the treatment of bacterial conjunctivitis. Larger studies are warranted.