Efficacy and safety of besifloxacin ophthalmic suspension 0.6 in children and adolescents with bacterial conjunctivitis: A post hoc, subgroup analysis of three randomized, double-masked, parallel-group, multicenter clinical trials

Pediatric Drugs

Volumn 12, Issue 2, 2010, Pages 105-112

  Comstock, Timothy L ^a   Paterno, Michael R ^a   Usner, Dale W ^a   Pichichero, Michael E ^b  

^a BAUSCH AND LOMB   (United States)

^b ROCHESTER GENERAL HOSPITAL   (United States)

Author keywords

Adolescents; Besifloxacin, therapeutic use; Children; Conjunctivitis, treatment; Research and development

Indexed keywords

BESIFLOXACIN; BESIVANCE; MOXIFLOXACIN; QUINOLINE DERIVED ANTIINFECTIVE AGENT; UNCLASSIFIED DRUG;

ADOLESCENT; ARTICLE; BLURRED VISION; CELLULITIS; CHEMOSIS; CHILD; CONJUNCTIVA DISEASE; CONJUNCTIVAL HEMORRHAGE; CONJUNCTIVITIS; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; EYE DISCHARGE; EYE INFLAMMATION; EYE IRRITATION; EYE MOVEMENT DISORDER; EYE PAIN; FEMALE; GROUPS BY AGE; HUMAN; INFANT; MAJOR CLINICAL STUDY; MALE; OCULAR PRURITUS; PERIORBITAL CELLULITIS; PRESCHOOL CHILD; PRIORITY JOURNAL; PUS; SCHOOL CHILD; TREATMENT OUTCOME; VIRAL CONJUNCTIVITIS; VISUAL ACUITY;

ADMINISTRATION, TOPICAL; ADOLESCENT; ANTI-BACTERIAL AGENTS; AZA COMPOUNDS; AZEPINES; CHILD; CHILD, PRESCHOOL; CONJUNCTIVITIS, BACTERIAL; DOUBLE-BLIND METHOD; FEMALE; FLUOROQUINOLONES; HUMANS; INFANT; MALE; OPHTHALMIC SOLUTIONS; QUINOLINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 77949450147     PISSN: 11745878     EISSN: 11792019     Source Type: Journal    
DOI: 10.2165/11534380-000000000-00000     Document Type: Article

References (30)

1. Høvding G. Acute bacterial conjunctivitis. Acta Ophthalmol 2008; 86: 5-17
2. Weiss A, Brisner JH, Nazar-Stewart V. Acute conjunctivitis in childhood. J Pediatr 1993; 122: 10-14
3. Morrow GL, Abbott RL. Conjunctivitis. Am Fam Physician 1998; 57: 735-746
4. Sheikh A, Hurwitz B. Antibiotics versus placebo for acute bacterial conjunctivitis. Cochrane Database Syst Rev 2006; (2): CD001211
5. Rose P. Management strategies for acute infective conjunctivitis in primary care: a systematic review. Expert Opin Pharmacother 2007; 8: 1903-1921
6. Patel PB, Diaz MC, Bennett JE, et al. Clinical features of bacterial conjunctivitis in children. Acad Emerg Med 2007; 14: 1-5
7. Diamant JI, Hwang DG. Therapy for bacterial conjunctivitis. Ophthalmol Clin North Am 1999; 12: 15-20
8. Ohnsman C, Ritterband D, O'Brien T, et al. Comparison of azithromycin and moxifloxacin against bacterial isolates causing conjunctivitis. Curr Med Res Opin 2007; 23: 2241-2249
9. Gross RD, Hoffman RO, Lindsay RN. A comparison of ciprofloxacin and tobramycin in bacterial conjunctivitis in children. Clin Pediatr (Phila) 1997; 36: 435-444
10. Blondeau JM. Fluoroquinolones: mechanism of action, classification, and development of resistance. Surv Ophthalmol 2004; 49 Suppl. 2: S73-8
11. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001; 23: 1296-1310
12. Asbell PA, Colby KA, Deng S, et al. Ocular TRUST: nationwide antimicrobial susceptibility patterns in ocular isolates. Am J Ophthalmol 2008; 145: 951-958
13. Asbell PA, Sahm DF, Shaw M, et al. Increasing prevalence of methicillin resistance in serious ocular infections caused by Staphylococcus aureus in the United States: 2000 to 2005. J Cataract Refract Surg 2008; 34: 814-818
14. Protzko E, Bowman L,Abelson M, et al., for the AzaSite Clinical Study Group. Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Invest Ophthalmol Vis Sci 2007; 48: 3425-3429
15. McDonnell G, Russell AD. Antiseptics and disinfectants: activity, action, and resistance. Clin Microbiol Rev 1999; 12: 147-179
16. Blondeau JM, Borsos S, Hesje CK. Antimicrobial efficacy of gatifloxacin and moxifloxacin with and without benzalkonium chloride compared with ciprofloxacin and levofloxacin against methicillin-resistant Staphylococcus aureus. J Chemother 2007; 19: 146-151
17. Hesje CK, Borsos SD, Blondeau JM. Benzalkonium chloride enhances antibacterial activity of gatifloxacin and reduces its propensity to select for fluoroquinolone-resistant strains. J Ocul Pharmacol Ther 2009; 25: 329-334
18. Cambau E, Matrat S, Pan X-S, et al. Target specificity of the new fluoroquinolone besifloxacin in Streptococcus pneumoniae, Staphylococcus aureus and Escherichia coli. J Antimicrob Chemother 2009; 63: 443-450
19. Morris TW, Hass W, Brunner LS, et al. Clinical efficacy of besifloxacin ophthalmic suspension: integrated microbiological analysis of 3 trials for topical treatment of bacterial conjunctivitis [poster]. Presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology; 2009 May 3-7; Fort Lauderdale (FL)
20. Haas W, Pillar CM, Zurenko GE, et al. Besifloxacin, a novel fluoroquinolone, has broad-spectrum in vitro activity against aerobic and anaerobic bacteria. Antimicrob Agents Chemother 2009; 53: 3552-3560
21. Brunner LS, Walsh PA, Norton SE, et al. Bactericidal activity of SS734, a novel fluoroquinolone, against pathogens associated with bacterial conjunctivitis [abstract]. Clin Microbiol Infect 2007; 13: P1680
22. McDonald MB, Blondeau JM, DeCory HH, et al. Multidrug-resistant strains in clinical trials of besifloxacin in the treatment of bacterial conjunctivitis [poster no. P0070]. Presented at the Annual Meeting of the American Academy of Ophthalmology; 2008 Nov 8-11; Atlanta (GA)
23. Haas W, Zurenko GE, Lee J, et al. Activity of besifloxacin and comparators against ciprofloxacin resistant Staphylococcus aureus and Staphylococcus epidermidis ocular isolates from 2005-2008 [poster]. Presented at the 3rd Congress of the Federation of European Microbiology Society (FEMS); 2009 Jun 28-Jul 22; Gothenberg
24. Ward KH, Lepage J-F, Driot J-Y. Nonclinical pharmacodynamics, pharmacokinetics, and safety of BOL-303224-A, a novel fluoroquinolone antimicrobial agent for topical ophthalmic use. J Ocular Pharmacol Ther 2007; 23: 243-256
25. Haas W, Brunner LS, Pillar C, et al. Bactericidal activity of besifloxacin and other ophthalmic antibacterials against recent ocular isolates. Presented at the Annual Meeting of the Association of Research in Vision and Ophthalmology; 2009 May 3-7; Fort Lauderdale (FL)
26. Karpecki P, DePaolis M, Paterno MR, et al. Evaluation of the clinical and microbial efficacy of besifloxacin compared to vehicle in the treatment of bacterial conjunctivitis. Clin Ther 2009; 31: 514-526
27. Tepedino ME, Heller WH, Usner DW, et al. Phase III efficacy and safety of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Curr Med Res Opin 2009; 25: 1159-1168
28. McDonald MB, Protzko EE, Brunner LS, et al. Efficacy and safety of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5% for treating bacterial conjunctivitis. Ophthalmology 2009; 116: 1615-1621
29. Lichtenstein SJ, Rinehart M. Efficacy and safety of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in pediatric patients. The Levofloxacin Bacterial Conjunctivitis Study Group. J AAPOS 2003; 7: 317-324
30. Liebowitz HM. Antibacterial effectiveness of ciprofloxacin 0.3% ophthalmic solution in the treatment of bacterial conjunctivitis. Am J Ophthalmol 1991; 112 (4 Suppl.): 29-33S