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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.

AbstractBACKGROUND 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.
AuthorsJesse DeLeon, Bruce E Silverstein, Catherine Allaire, Lynne S Gearinger, Kirk M Bateman, Timothy W Morris, Timothy L Comstock
JournalClinical drug investigation (Clin Drug Investig) Vol. 32 Issue 5 Pg. 303-17 (May 01 2012) ISSN: 1179-1918 [Electronic] New Zealand
PMID22420526 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Bacterial Agents
  • Azepines
  • Fluoroquinolones
  • Suspensions
  • besifloxacin
Topics
  • Administration, Ophthalmic
  • Adolescent
  • Adult
  • Anti-Bacterial Agents (administration & dosage, adverse effects, therapeutic use)
  • Azepines (administration & dosage, adverse effects, therapeutic use)
  • Child
  • Child, Preschool
  • Conjunctivitis, Bacterial (drug therapy, microbiology)
  • Double-Blind Method
  • Female
  • Fluoroquinolones (administration & dosage, adverse effects, therapeutic use)
  • Follow-Up Studies
  • Gram-Negative Bacteria (isolation & purification)
  • Gram-Positive Bacteria (isolation & purification)
  • Humans
  • Infant
  • Male
  • Middle Aged
  • Ophthalmoscopy
  • Suspensions
  • Treatment Outcome
  • Young Adult

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