NDLI: Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children.

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Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children.

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Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	DeLeon, Jesse Silverstein, Bruce E. Allaire, Catherine Gearinger, Lynne S. Bateman, Kirk M. Morris, Timothy W. Comstock, Timothy L.
Description	Country affiliation: United States Author Affiliation: DeLeon J ( Center for Clinical Trials, LLC, Paramount, CA, USA.)
Abstract	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.
File Format	HTM / HTML
ISSN	11732563
Issue Number	5
Volume Number	32
e-ISSN	11791918
Journal	Clinical Drug Investigation
Language	English
Publisher	Springer
Publisher Date	2012-05-01
Publisher Place	New Zealand (Aotearoa)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Anti-bacterial Agents Administration & Dosage Azepines Conjunctivitis, Bacterial Drug Therapy Fluoroquinolones Administration, Ophthalmic Adolescent Adult Adverse Effects Therapeutic Use Child Child, Preschool Microbiology Double-blind Method Female Follow-up Studies Gram-negative Bacteria Isolation & Purification Gram-positive Bacteria Humans Infant Male Middle Aged Ophthalmoscopy Suspensions Treatment Outcome Young Adult Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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