PMID- 20629472
OWN - NLM
STAT- MEDLINE
DCOM- 20101019
LR  - 20211020
IS  - 1173-2563 (Print)
IS  - 1173-2563 (Linking)
VI  - 30
IP  - 10
DP  - 2010
TI  - Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the 
      treatment of bacterial conjunctivitis: data from six clinical and phase I safety 
      studies.
PG  - 675-85
LID - 10.2165/11536720-000000000-00000 [doi]
AB  - BACKGROUND: Besifloxacin is a novel fluoroquinolone, specifically a 
      chloro-fluoroquinolone, with potent broad-spectrum bactericidal activity for the 
      topical treatment of bacterial conjunctivitis. OBJECTIVE: The objective of this 
      report was to provide a comprehensive assessment of the safety and tolerability 
      of besifloxacin ophthalmic suspension 0.6% across clinical and phase I safety 
      studies. METHODS: Data were drawn from two phase I safety studies in healthy 
      adults, an open-label, phase II pharmacokinetic study of patients with bacterial 
      conjunctivitis and from integrated data from three randomized, double-masked, 
      parallel-group, safety and efficacy studies of patients with bacterial 
      conjunctivitis (two were vehicle controlled and one was active controlled with 
      moxifloxacin ophthalmic solution 0.5%, as base). Safety assessments included 
      changes in visual acuity, ocular assessments with ophthalmoscopy and 
      biomicroscopy, and assessment of adverse events (AEs). RESULTS: Safety data for 
      besifloxacin ophthalmic suspension 0.6% were available for 1350 patients, 
      including 1192 patients (1810 eyes) in the integrated analysis. Systemic exposure 
      following topical administration of besifloxacin ophthalmic suspension 0.6% was 
      negligible. No changes were seen in corneal endothelial cell density. In the 
      integrated safety analysis of the three safety and efficacy studies, the most 
      commonly reported ocular AEs in study eyes receiving besifloxacin ophthalmic 
      suspension 0.6% were blurred vision (2.1%), eye pain (1.8%), eye irritation 
      (1.4%), nonspecific conjunctivitis (1.2%) and eye pruritus (1.1%). Blurred 
      vision, eye irritation and nonspecific conjunctivitis occurred in significantly 
      fewer besifloxacin-treated patients than in vehicle-treated patients (p < or = 
      0.05). Headache (1.8%) was the most frequently reported non-ocular AE. Most AEs 
      were mild in severity and there were no treatment-related serious AEs. 
      Besifloxacin ophthalmic suspension 0.6% did not significantly affect visual 
      acuity, biomicroscopy or ophthalmoscopy compared with vehicle or moxifloxacin. 
      CONCLUSION: The results from this comprehensive data set of 1350 patients 
      demonstrate that besifloxacin ophthalmic suspension 0.6% has a favourable safety 
      profile and is well tolerated.
FAU - Comstock, Timothy L
AU  - Comstock TL
AD  - Medical Affairs, Global Pharmaceutical, Bausch & Lomb, Inc., Rochester, New York 
      14609, USA. tcomstock@bausch.com
FAU - Paterno, Michael R
AU  - Paterno MR
FAU - Decory, Heleen H
AU  - Decory HH
FAU - Usner, Dale W
AU  - Usner DW
LA  - eng
SI  - ClinicalTrials.gov/NCT00347932
SI  - ClinicalTrials.gov/NCT00348348
SI  - ClinicalTrials.gov/NCT00622908
PT  - Journal Article
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 (Ophthalmic Solutions)
RN  - BFE2NBZ7NX (besifloxacin)
SB  - IM
MH  - Administration, Topical
MH  - Adolescent
MH  - Adult
MH  - Anti-Bacterial Agents/*administration & dosage/adverse effects/pharmacokinetics
MH  - Azepines/*administration & dosage/adverse effects/pharmacokinetics
MH  - Child
MH  - Clinical Trials, Phase I as Topic
MH  - Conjunctivitis, Bacterial/*drug therapy/microbiology/physiopathology
MH  - Double-Blind Method
MH  - Evidence-Based Medicine
MH  - Female
MH  - Fluoroquinolones/*administration & dosage/adverse effects/pharmacokinetics
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multicenter Studies as Topic
MH  - Ophthalmic Solutions
MH  - Ophthalmoscopy
MH  - Randomized Controlled Trials as Topic
MH  - Risk Assessment
MH  - Treatment Outcome
MH  - Visual Acuity/drug effects
MH  - Young Adult
EDAT- 2010/07/16 06:00
MHDA- 2010/10/20 06:00
CRDT- 2010/07/16 06:00
PHST- 2010/07/16 06:00 [entrez]
PHST- 2010/07/16 06:00 [pubmed]
PHST- 2010/10/20 06:00 [medline]
AID - 10.2165/11536720-000000000-00000 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000.