PMID- 22420526
OWN - NLM
STAT- MEDLINE
DCOM- 20120810
LR  - 20211021
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 32
IP  - 5
DP  - 2012 May 1
TI  - Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in 
      the treatment of bacterial conjunctivitis in adults and children.
PG  - 303-17
LID - 10.2165/11632470-000000000-00000 [doi]
AB  - BACKGROUND AND OBJECTIVE: Besifloxacin ophthalmic suspension 0.6% given thrice 
      daily for 5 days is safe and effective in the treatment of patients with 
      bacterial conjunctivitis. This study evaluated the safety and efficacy of 
      besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days 
      compared with vehicle in the treatment of bacterial conjunctivitis. STUDY DESIGN: 
      This was a multicenter, double-masked, randomized, vehicle-controlled, 
      parallel-group study. METHODS: A total of 474 patients aged >/=1 year with 
      bacterial conjunctivitis were randomized in a 1 : 1 ratio to receive either 
      besifloxacin ophthalmic suspension 0.6% or vehicle administered twice daily for 3 
      days. There were three study visits: day 1 (the baseline visit), day 4/5 (visit 
      2), and day 7 +/- 1 (visit 3). The co-primary efficacy endpoints were bacterial 
      eradication and clinical resolution at day 4/5 in designated study eyes of 
      patients with culture-confirmed bacterial conjunctivitis. Secondary efficacy 
      endpoints were bacterial eradication and clinical resolution at day 7 +/- 1, 
      individual clinical outcomes of ocular discharge and bulbar conjunctival 
      injection at all visits; and microbial and clinical outcomes for overall 
      bacterial species and individual Gram-positive and Gram-negative bacterial 
      species at each follow-up visit. Safety endpoints included adverse events (AEs), 
      changes in visual acuity and biomicroscopy findings at each visit, and changes in 
      ophthalmoscopy findings at day 7 +/- 1. RESULTS: Bacterial eradication and clinical 
      resolution rates were significantly higher in the besifloxacin group than in the 
      vehicle group (115/135 [85.2%] vs 77/141 [54.6%], p < 0.001, and 89/135 [65.9%] 
      vs 62/141 [44.0%], p < 0.001, respectively) at day 4/5. Rates of bacterial 
      eradication continued to be significantly greater in the besifloxacin group 
      (115/135 [85.2%] vs 91/141 [64.5%], respectively; p < 0.001) at day 7 +/- 1; 
      however, the rates of clinical resolution did not differ significantly between 
      the groups (103/135 [76.3%] and 94/141 [66.7%], p = 0.209) at this visit. Ocular 
      discharge and bulbar conjunctival injection at each visit were consistent with 
      the primary outcomes. Clinical resolution and bacterial eradication with 
      Gram-positive or Gram-negative organisms were consistent with the overall 
      findings. All AEs in both groups were of mild or moderate severity and were 
      considered unrelated to the treatment. CONCLUSION: Treatment with besifloxacin 
      ophthalmic suspension 0.6% administered twice daily for 3 days was effective and 
      safe in adults and children with bacterial conjunctivitis. CLINICAL TRIAL 
      REGISTRATION: Registered at ClinicalTrials.gov as NCT00972777.
FAU - DeLeon, Jesse
AU  - DeLeon J
AD  - Center for Clinical Trials, LLC, Paramount, CA, USA.
FAU - Silverstein, Bruce E
AU  - Silverstein BE
FAU - Allaire, Catherine
AU  - Allaire C
FAU - Gearinger, Lynne S
AU  - Gearinger LS
FAU - Bateman, Kirk M
AU  - Bateman KM
FAU - Morris, Timothy W
AU  - Morris TW
FAU - Comstock, Timothy L
AU  - Comstock TL
LA  - eng
SI  - ClinicalTrials.gov/NCT00972777
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Azepines)
RN  - 0 (Fluoroquinolones)
RN  - 0 (Suspensions)
RN  - BFE2NBZ7NX (besifloxacin)
SB  - IM
MH  - Administration, Ophthalmic
MH  - Adolescent
MH  - Adult
MH  - Anti-Bacterial Agents/*administration & dosage/adverse effects/therapeutic use
MH  - Azepines/*administration & dosage/adverse effects/therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Conjunctivitis, Bacterial/*drug therapy/microbiology
MH  - Double-Blind Method
MH  - Female
MH  - Fluoroquinolones/*administration & dosage/adverse effects/therapeutic use
MH  - Follow-Up Studies
MH  - Gram-Negative Bacteria/isolation & purification
MH  - Gram-Positive Bacteria/isolation & purification
MH  - Humans
MH  - Infant
MH  - Male
MH  - Middle Aged
MH  - Ophthalmoscopy
MH  - Suspensions
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2012/03/17 06:00
MHDA- 2012/08/11 06:00
CRDT- 2012/03/17 06:00
PHST- 2012/03/17 06:00 [entrez]
PHST- 2012/03/17 06:00 [pubmed]
PHST- 2012/08/11 06:00 [medline]
AID - 10.2165/11632470-000000000-00000 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2012 May 1;32(5):303-17. doi: 
      10.2165/11632470-000000000-00000.