PMID- 28078599
OWN - NLM
STAT- MEDLINE
DCOM- 20170503
LR  - 20181202
IS  - 1179-6901 (Electronic)
IS  - 1174-5886 (Print)
IS  - 1174-5886 (Linking)
VI  - 17
IP  - 1
DP  - 2017 Mar
TI  - Besifloxacin Ophthalmic Suspension 0.6% Compared with Gatifloxacin Ophthalmic 
      Solution 0.3% for the Treatment of Bacterial Conjunctivitis in Neonates.
PG  - 167-175
LID - 10.1007/s40268-016-0164-6 [doi]
AB  - 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.
FAU - Sanfilippo, Christine M
AU  - Sanfilippo CM
AD  - Bausch & Lomb, 1400 North Goodman Street, Rochester, NY, 14609, USA. 
      Christine.sanfilippo@bausch.com.
FAU - Allaire, Catherine M
AU  - Allaire CM
AD  - , 38, rue de Villiers, 92300 , Levallois Perret, France.
FAU - DeCory, Heleen H
AU  - DeCory HH
AD  - Bausch & Lomb, 1400 North Goodman Street, Rochester, NY, 14609, USA.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - New Zealand
TA  - Drugs R D
JT  - Drugs in R&D
JID - 100883647
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Azepines)
RN  - 0 (Fluoroquinolones)
RN  - 0 (Ophthalmic Solutions)
RN  - BFE2NBZ7NX (besifloxacin)
RN  - L4618BD7KJ (Gatifloxacin)
SB  - IM
MH  - Anti-Bacterial Agents/administration & dosage/pharmacology/*therapeutic use
MH  - Azepines/*administration & dosage/pharmacology/*therapeutic use
MH  - Conjunctivitis, Bacterial/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Fluoroquinolones/*administration & dosage/pharmacology/*therapeutic use
MH  - Gatifloxacin
MH  - Gram-Positive Bacteria/drug effects
MH  - Humans
MH  - Infant, Newborn
MH  - Male
MH  - Microbial Sensitivity Tests
MH  - Ophthalmic Solutions/administration & dosage/pharmacology/*therapeutic use
PMC - PMC5318332
COIS- CONFLICT OF INTEREST: Christine M. Sanfilippo, Catherine M. Allaire, Heleen H. 
      DeCory are employees of Bausch & Lomb, Inc. ETHICAL APPROVAL: All procedures 
      performed in studies involving human participants were in accordance with the 
      ethical standards of the institutional and/or national research committee and 
      with the 1964 Helsinki declaration and its later amendments or comparable ethical 
      standards.
EDAT- 2017/01/13 06:00
MHDA- 2017/05/04 06:00
PMCR- 2017/01/11
CRDT- 2017/01/13 06:00
PHST- 2017/01/13 06:00 [pubmed]
PHST- 2017/05/04 06:00 [medline]
PHST- 2017/01/13 06:00 [entrez]
PHST- 2017/01/11 00:00 [pmc-release]
AID - 10.1007/s40268-016-0164-6 [pii]
AID - 164 [pii]
AID - 10.1007/s40268-016-0164-6 [doi]
PST - ppublish
SO  - Drugs R D. 2017 Mar;17(1):167-175. doi: 10.1007/s40268-016-0164-6.