PMID- 26065499
OWN - NLM
STAT- MEDLINE
DCOM- 20160315
LR  - 20240124
IS  - 2162-0989 (Electronic)
IS  - 2162-0989 (Linking)
VI  - 4
IP  - 3
DP  - 2015 May-Jun
TI  - Clinical and Antibacterial Efficacy and Safety of Besifloxacin Ophthalmic 
      Suspension Compared With Moxifloxacin Ophthalmic Solution.
PG  - 140-5
LID - 10.1097/APO.0000000000000055 [doi]
AB  - PURPOSE: To evaluate the efficacy of besifloxacin ophthalmic suspension 0.6% 
      compared with moxifloxacin ophthalmic solution 0.5% in the treatment of bacterial 
      conjunctivitis in an Indian population. DESIGN: Multicenter, randomized, 
      double-masked, active-controlled, parallel-group, clinical trial, including 6 
      clinical sites in India. METHODS: Patients were randomized to receive 1 drop of 
      besifloxacin or moxifloxacin in the infected eye(s), 3 times daily, for 5 days. 
      Primary efficacy end points included clinical resolution and bacterial 
      eradication at day 5. Secondary efficacy end points included clinical resolution 
      and bacterial eradication at day 8, ocular discharge, bulbar conjunctival 
      injection, investigator's global assessment, and bacterial eradication by 
      species. Efficacy was analyzed using the Cochran-Mantel-Haenszel and Pearson chi2 
      tests. Safety was assessed by the incidence of ocular and nonocular 
      treatment-emergent adverse events (AEs), changes in visual acuity, and 
      biomicroscopy and ophthalmoscopy findings. Data presented are that for the subset 
      of patients from India. RESULTS: Of the 123 patients randomized at clinical sites 
      in India, 96.7% completed the study. Day 5 differences in microbial eradication 
      (100% besifloxacin vs 96.3% moxifloxacin) and in clinical resolution (78.9% 
      besifloxacin vs 71.4% moxifloxacin) were not statistically significant. No 
      statistically significant between-group differences were observed for secondary 
      end points. All ocular AEs in both groups were mild or moderate in severity. 
      There were no drug-related ocular AEs with besifloxacin. CONCLUSIONS: Treatment 
      of bacterial conjunctivitis with besifloxacin 0.6% produces similar antibacterial 
      and clinical efficacy as that with moxifloxacin 0.5% in an Indian population, 
      with no clinically meaningful safety concerns.
FAU - Garg, Prashant
AU  - Garg P
AD  - From the *L. V. Prasad Eye Institute, Hyderabad; daggerDr Shroff's Charity Eye Centre, 
      Delhi; double daggerShroff Eye Centre, Gurgaon, Haryana; and  section signDr R. P. Centre for Ophthalmic 
      Sciences, AIIMS, New Delhi, India; and  paragraph signMedical Affairs, Bausch + Lomb, 
      Rochester, NY and  parallelR&D Microbiology and Sterilization Sciences.
FAU - Mathur, Umang
AU  - Mathur U
FAU - Sony, Parul
AU  - Sony P
FAU - Tandon, Radhika
AU  - Tandon R
FAU - Morris, Timothy W
AU  - Morris TW
FAU - Comstock, Timothy L
AU  - Comstock TL
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Asia Pac J Ophthalmol (Phila)
JT  - Asia-Pacific journal of ophthalmology (Philadelphia, Pa.)
JID - 101583622
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Azepines)
RN  - 0 (Fluoroquinolones)
RN  - 0 (Ophthalmic Solutions)
RN  - 0 (Suspensions)
RN  - 0 (Topoisomerase II Inhibitors)
RN  - BFE2NBZ7NX (besifloxacin)
RN  - U188XYD42P (Moxifloxacin)
SB  - IM
MH  - Anti-Bacterial Agents/administration & dosage
MH  - Azepines/*administration & dosage
MH  - Conjunctivitis, Bacterial/*drug therapy
MH  - Double-Blind Method
MH  - Fluoroquinolones/*administration & dosage
MH  - Follow-Up Studies
MH  - Humans
MH  - Moxifloxacin
MH  - Ophthalmic Solutions/administration & dosage
MH  - Suspensions/administration & dosage
MH  - Topoisomerase II Inhibitors/administration & dosage
MH  - Treatment Outcome
EDAT- 2015/06/13 06:00
MHDA- 2016/03/16 06:00
CRDT- 2015/06/13 06:00
PHST- 2015/06/13 06:00 [entrez]
PHST- 2015/06/13 06:00 [pubmed]
PHST- 2016/03/16 06:00 [medline]
AID - S2162-0989(23)00573-X [pii]
AID - 10.1097/APO.0000000000000055 [doi]
PST - ppublish
SO  - Asia Pac J Ophthalmol (Phila). 2015 May-Jun;4(3):140-5. doi: 
      10.1097/APO.0000000000000055.