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Clinical Drug Investigation

, Volume 32, Issue 5, pp 303–317 | Cite as

Besifloxacin Ophthalmic Suspension 0.6% Administered Twice Daily for 3 Days in the Treatment of Bacterial Conjunctivitis in Adults and Children

  • Jesse DeLeon
  • Bruce E. Silverstein
  • Catherine Allaire
  • Lynne S. Gearinger
  • Kirk M. Bateman
  • Timothy W. Morris
  • Timothy L. ComstockEmail author
Original Research Article

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.

Keywords

Clinical Resolution Bacterial Eradication Bacterial Conjunctivitis Besifloxacin Ocular Discharge 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

This study was sponsored by Bausch & Lomb, Inc., who designed and managed the study. All authors had full access to the study data. Dr Allaire, Mr Bateman, Ms Gearinger, Dr Morris and Dr Comstock are employees of Bausch & Lomb. The authors thank Raman Bedi, MD, for the critical review of the manuscript and IrisARC-Analytics, Research & Consulting (Chandigarh, India) for writing and editing assistance. Statistical analysis was conducted by Howard Proskin & Associates (Rochester, NY, USA).

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Copyright information

© Adis Data Information BV 2012

Authors and Affiliations

  • Jesse DeLeon
    • 1
  • Bruce E. Silverstein
    • 2
  • Catherine Allaire
    • 3
  • Lynne S. Gearinger
    • 3
  • Kirk M. Bateman
    • 3
  • Timothy W. Morris
    • 3
  • Timothy L. Comstock
    • 3
    Email author
  1. 1.Center for Clinical TrialsLLCParamountUSA
  2. 2.Shasta Eye Medical Group, Inc.ReddingUSA
  3. 3.Global PharmaceuticalBausch & Lomb, Inc.RochesterUSA

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