메뉴 건너뛰기




Volumn 33, Issue 1, 2011, Pages 13-26

Efficacy and Tolerability of Besifloxacin Ophthalmic Suspension 0.6% Administered Twice Daily for 3 Days in the Treatment of Bacterial Conjunctivitis: A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study in Adults and Children

Author keywords

Bacterial conjunctivitis; Bacterial eradication; Besifloxacin; BID; Clinical resolution; Fluoroquinolone

Indexed keywords

BESIFLOXACIN; DRUG VEHICLE;

EID: 79952531868     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.12.004     Document Type: Article
Times cited : (35)

References (50)
  • 1
    • 39349090858 scopus 로고    scopus 로고
    • Acute bacterial conjunctivitis
    • Høvding G. Acute bacterial conjunctivitis. Acta Ophthalmol 2008, 86:5-17.
    • (2008) Acta Ophthalmol , vol.86 , pp. 5-17
    • Høvding, G.1
  • 2
    • 35348943365 scopus 로고    scopus 로고
    • Do general practitioners adhere to the guideline on infectious conjunctivitis?. Results of the Second Dutch National Survey of General Practice
    • Rietveld R.P., ter Riet G., Bindels P.J., et al. Do general practitioners adhere to the guideline on infectious conjunctivitis?. Results of the Second Dutch National Survey of General Practice. BMC Fam Pract 2007, 8:54.
    • (2007) BMC Fam Pract , vol.8 , pp. 54
    • Rietveld, R.P.1    ter Riet, G.2    Bindels, P.J.3
  • 3
    • 33745029542 scopus 로고    scopus 로고
    • Antibiotics versus placebo for acute bacterial conjunctivitis
    • CD001211
    • Sheikh A., Hurwitz B. Antibiotics versus placebo for acute bacterial conjunctivitis. Cochrane Database Syst Rev 2006, (2). CD001211.
    • (2006) Cochrane Database Syst Rev , Issue.2
    • Sheikh, A.1    Hurwitz, B.2
  • 4
    • 24944432186 scopus 로고    scopus 로고
    • Clinical and bacterial characteristics of acute bacterial conjunctivitis in children in the antibiotic resistance era
    • Buznach N., Dagan R., Greenberg D. Clinical and bacterial characteristics of acute bacterial conjunctivitis in children in the antibiotic resistance era. Pediatr Infect Dis J 2005, 24:823-828.
    • (2005) Pediatr Infect Dis J , vol.24 , pp. 823-828
    • Buznach, N.1    Dagan, R.2    Greenberg, D.3
  • 5
    • 21844437362 scopus 로고    scopus 로고
    • Chloramphenicol treatment for acute infective conjunctivitis in children in primary care: A randomised double-blind placebo-controlled trial
    • Rose P.W., Harnden A., Brueggemann A.B., et al. Chloramphenicol treatment for acute infective conjunctivitis in children in primary care: A randomised double-blind placebo-controlled trial. Lancet 2005, 366:37-43.
    • (2005) Lancet , vol.366 , pp. 37-43
    • Rose, P.W.1    Harnden, A.2    Brueggemann, A.B.3
  • 6
    • 51249092238 scopus 로고    scopus 로고
    • Bacterial conjunctivitis: A review for internists
    • Tarabishy A.B., Jeng B.H. Bacterial conjunctivitis: A review for internists. Cleve Clin J Med 2008, 75:507-512.
    • (2008) Cleve Clin J Med , vol.75 , pp. 507-512
    • Tarabishy, A.B.1    Jeng, B.H.2
  • 11
    • 37249064995 scopus 로고    scopus 로고
    • Clinical development of 1% azithromycin in DuraSite, a topical azalide anti-infective for ocular surface therapy
    • Friedlaender M.H., Protzko E. Clinical development of 1% azithromycin in DuraSite, a topical azalide anti-infective for ocular surface therapy. Clin Ophthalmol 2007, 1:3-10.
    • (2007) Clin Ophthalmol , vol.1 , pp. 3-10
    • Friedlaender, M.H.1    Protzko, E.2
  • 12
    • 67749108274 scopus 로고    scopus 로고
    • Besifloxacin, a novel fluoroquinolone, has broad-spectrum in vitro activity against aerobic and anaerobic bacteria
    • Haas W., Pillar C.M., Zurenko G.E., et al. Besifloxacin, a novel fluoroquinolone, has broad-spectrum in vitro activity against aerobic and anaerobic bacteria. Antimicrob Agents Chemother 2009, 53:3552-3560.
    • (2009) Antimicrob Agents Chemother , vol.53 , pp. 3552-3560
    • Haas, W.1    Pillar, C.M.2    Zurenko, G.E.3
  • 13
    • 34250800221 scopus 로고    scopus 로고
    • Non-clinical pharmacodynamics, pharmacokinetics, and safety of BOL-303224-A, a novel fluoroquinolone antimicrobial agent for topical ophthalmic use
    • Ward K.W., Lepage J.F., Driot J.Y. Non-clinical pharmacodynamics, pharmacokinetics, and safety of BOL-303224-A, a novel fluoroquinolone antimicrobial agent for topical ophthalmic use. J Ocul Pharmacol Ther 2007, 23:243-256.
    • (2007) J Ocul Pharmacol Ther , vol.23 , pp. 243-256
    • Ward, K.W.1    Lepage, J.F.2    Driot, J.Y.3
  • 14
    • 77954188913 scopus 로고    scopus 로고
    • Bactericidal activity of besifloxacin against staphylococci, Streptococcus pneumoniae and Haemophilus influenzae
    • Haas W., Pillar C.M., Hesje C.K., et al. Bactericidal activity of besifloxacin against staphylococci, Streptococcus pneumoniae and Haemophilus influenzae. J Antimicrob Chemother 2010, 65:1441-1447.
    • (2010) J Antimicrob Chemother , vol.65 , pp. 1441-1447
    • Haas, W.1    Pillar, C.M.2    Hesje, C.K.3
  • 15
    • 64849100973 scopus 로고    scopus 로고
    • Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study
    • Karpecki P., Depaolis M., Hunter J.A., et al. Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study. Clin Ther 2009, 31:514-526.
    • (2009) Clin Ther , vol.31 , pp. 514-526
    • Karpecki, P.1    Depaolis, M.2    Hunter, J.A.3
  • 16
    • 67649400450 scopus 로고    scopus 로고
    • Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis
    • Tepedino M.E., Heller W.H., Usner D.W., et al. Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Curr Med Res Opin 2009, 25:1159-1169.
    • (2009) Curr Med Res Opin , vol.25 , pp. 1159-1169
    • Tepedino, M.E.1    Heller, W.H.2    Usner, D.W.3
  • 17
    • 69349091130 scopus 로고    scopus 로고
    • Efficacy and safety of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5% for treating bacterial conjunctivitis
    • McDonald M.B., Protzko E.E., Brunner L.S., et al. Efficacy and safety of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5% for treating bacterial conjunctivitis. Ophthalmology 2009, 116:1615-1623.
    • (2009) Ophthalmology , vol.116 , pp. 1615-1623
    • McDonald, M.B.1    Protzko, E.E.2    Brunner, L.S.3
  • 18
    • 77949450147 scopus 로고    scopus 로고
    • 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
    • Comstock T.L., Paterno M.R., Usner D.W., Pichichero M.E. 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. Paediatr Drugs 2010, 12:105-112.
    • (2010) Paediatr Drugs , vol.12 , pp. 105-112
    • Comstock, T.L.1    Paterno, M.R.2    Usner, D.W.3    Pichichero, M.E.4
  • 19
    • 68549092580 scopus 로고    scopus 로고
    • Ocular pharmacokinetics of besifloxacin following topical administration to rabbits, monkeys, and humans
    • Proksch J.W., Granvil C.P., Siou-Mermet R., et al. Ocular pharmacokinetics of besifloxacin following topical administration to rabbits, monkeys, and humans. J Ocul Pharmacol Ther 2009, 25:335-344.
    • (2009) J Ocul Pharmacol Ther , vol.25 , pp. 335-344
    • Proksch, J.W.1    Granvil, C.P.2    Siou-Mermet, R.3
  • 20
    • 0026052336 scopus 로고
    • Antibacterial effectiveness of ciprofloxacin 0.3% ophthalmic solution in the treatment of bacterial conjunctivitis
    • Leibowitz H.M. Antibacterial effectiveness of ciprofloxacin 0.3% ophthalmic solution in the treatment of bacterial conjunctivitis. Am J Ophthalmol 1991, 112(Suppl):29S-33S.
    • (1991) Am J Ophthalmol , vol.112 , Issue.SUPPL.
    • Leibowitz, H.M.1
  • 23
    • 79952500651 scopus 로고    scopus 로고
    • Eradication of bacteria from infected eyes by a three day BID treatment with moxifloxacin ophthalmic solution, 0.5%
    • E-abstract 2116
    • Schlech B.A., Stroman D.W., Gower L., Cupp G. Eradication of bacteria from infected eyes by a three day BID treatment with moxifloxacin ophthalmic solution, 0.5%. Invest Ophthal Vis Sci 2003, 44. E-abstract 2116.
    • (2003) Invest Ophthal Vis Sci , vol.44
    • Schlech, B.A.1    Stroman, D.W.2    Gower, L.3    Cupp, G.4
  • 24
    • 0041942599 scopus 로고    scopus 로고
    • Early clinical and microbiological responses in the treatment of bacterial conjunctivitis with moxifloxacin ophthalmic solution 0.5% (vigamox) using BID dosing
    • Gross R.D., Lichtenstein S.J., Schlech B.A. Early clinical and microbiological responses in the treatment of bacterial conjunctivitis with moxifloxacin ophthalmic solution 0.5% (vigamox) using BID dosing. Todays Ther Trends 2003, 21:227-237.
    • (2003) Todays Ther Trends , vol.21 , pp. 227-237
    • Gross, R.D.1    Lichtenstein, S.J.2    Schlech, B.A.3
  • 26
    • 0041704997 scopus 로고    scopus 로고
    • A phase III, placebo controlled clinical trial of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis
    • Levofloxacin Bacterial Conjunctivitis Placebo-Controlled Study Group
    • Hwang D.G., Schanzlin D.J., Rotberg M.H., et al. A phase III, placebo controlled clinical trial of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. Br J Ophthalmol 2003, 87:1004-1009. Levofloxacin Bacterial Conjunctivitis Placebo-Controlled Study Group.
    • (2003) Br J Ophthalmol , vol.87 , pp. 1004-1009
    • Hwang, D.G.1    Schanzlin, D.J.2    Rotberg, M.H.3
  • 27
    • 64849110754 scopus 로고    scopus 로고
    • Moxifloxacin ophthalmic solution 0.5% hastens cure and eradicates the causative pathogens of bacterial conjunctivitis in pediatric and adult patients
    • E-abstract 2114
    • Katz H.R., Andrews W., Creager D., et al. Moxifloxacin ophthalmic solution 0.5% hastens cure and eradicates the causative pathogens of bacterial conjunctivitis in pediatric and adult patients. Invest Ophthal Vis Sci 2003, 44. E-abstract 2114.
    • (2003) Invest Ophthal Vis Sci , vol.44
    • Katz, H.R.1    Andrews, W.2    Creager, D.3
  • 28
    • 16844371197 scopus 로고    scopus 로고
    • A randomized, investigator-masked clinical trial comparing the efficacy and safety of gatifloxacin 0.3% administered BID versus QID for the treatment of acute bacterial conjunctivitis
    • Gatifloxacin BID/QID Study Group
    • Yee R.W., Tepedino M., Bernstein P., et al. A randomized, investigator-masked clinical trial comparing the efficacy and safety of gatifloxacin 0.3% administered BID versus QID for the treatment of acute bacterial conjunctivitis. Curr Med Res Opin 2005, 21:425-431. Gatifloxacin BID/QID Study Group.
    • (2005) Curr Med Res Opin , vol.21 , pp. 425-431
    • Yee, R.W.1    Tepedino, M.2    Bernstein, P.3
  • 29
    • 67649358607 scopus 로고    scopus 로고
    • Clinical and microbiological efficacy of levofloxacin administered three times a day for the treatment of bacterial conjunctivitis
    • Levofloxacin Bacterial Conjunctivitis Dosage Study Group
    • Szaflik J., Szaflik J.P., Kaminska A. Clinical and microbiological efficacy of levofloxacin administered three times a day for the treatment of bacterial conjunctivitis. Eur J Ophthalmol 2009, 19:1-9. Levofloxacin Bacterial Conjunctivitis Dosage Study Group.
    • (2009) Eur J Ophthalmol , vol.19 , pp. 1-9
    • Szaflik, J.1    Szaflik, J.P.2    Kaminska, A.3
  • 30
    • 79952504153 scopus 로고    scopus 로고
    • ARMOR, a new prospective, multicenter surveillance study to determine the in vitro activity profile of besifloxacin and comparators against ocular pathogens from the US. Presented at: Annual Meeting of the Association for Research in Vision and Ophthalmology; May ; Fort Lauderdale, Fla.
    • Haas W, Pillar C, Torres M, et al. ARMOR, a new prospective, multicenter surveillance study to determine the in vitro activity profile of besifloxacin and comparators against ocular pathogens from the US. Presented at: Annual Meeting of the Association for Research in Vision and Ophthalmology; May 2-6, 2010; Fort Lauderdale, Fla.
    • (2010) , Issue.2-6
    • Haas, W.1    Pillar, C.2    Torres, M.3
  • 33
    • 79952494246 scopus 로고    scopus 로고
    • In vitro activity of besifloxacin, ciprofloxacin, gatifloxacin, levofloxacin, and moxifloxacin against ciprofloxacin-resistant ocular Staphylococcus aureus and Staphylococcus epidermidis. Presented at: 5th International Conference on Ocular Infections; February Palm Beach, Fla.
    • Gearinger LS, Haas W, Morris TW. In vitro activity of besifloxacin, ciprofloxacin, gatifloxacin, levofloxacin, and moxifloxacin against ciprofloxacin-resistant ocular Staphylococcus aureus and Staphylococcus epidermidis. Presented at: 5th International Conference on Ocular Infections; February 18-21, 2010; Palm Beach, Fla.
    • (2010) , Issue.18-21
    • Gearinger, L.S.1    Haas, W.2    Morris, T.W.3
  • 34
    • 79952503924 scopus 로고    scopus 로고
    • Activity of besifloxacin and competitors against ciprofloxacin resistant Staphylococcus aureus and Staphylococcus epidermidis ocular isolates from 2005-2008. Presented at: 3rd Congress of the Federation of European Microbiologists; June 28-July 2, Göteborg, Sweden.
    • Haas W, Zurenko GE, Lee J, et al. Activity of besifloxacin and competitors against ciprofloxacin resistant Staphylococcus aureus and Staphylococcus epidermidis ocular isolates from 2005-2008. Presented at: 3rd Congress of the Federation of European Microbiologists; June 28-July 2, 2009; Göteborg, Sweden.
    • (2009)
    • Haas, W.1    Zurenko, G.E.2    Lee, J.3
  • 35
    • 77955589135 scopus 로고    scopus 로고
    • Emerging antibiotic resistance in ocular infections and the role of fluoroquinolones
    • McDonald M., Blondeau J. Emerging antibiotic resistance in ocular infections and the role of fluoroquinolones. J Cataract Refract Surg 2010, 36:1588-1598.
    • (2010) J Cataract Refract Surg , vol.36 , pp. 1588-1598
    • McDonald, M.1    Blondeau, J.2
  • 36
    • 43949112605 scopus 로고    scopus 로고
    • Ocular TRUST: Nationwide antimicrobial susceptibility patterns in ocular isolates
    • Asbell P.A., Colby K.A., Deng S., et al. Ocular TRUST: Nationwide antimicrobial susceptibility patterns in ocular isolates. Am J Ophthalmol 2008, 145:951-958.
    • (2008) Am J Ophthalmol , vol.145 , pp. 951-958
    • Asbell, P.A.1    Colby, K.A.2    Deng, S.3
  • 37
    • 42949133281 scopus 로고    scopus 로고
    • Increasing prevalence of methicillin resistance in serious ocular infections caused by Staphylococcus aureus in the United States: 2000 to 2005
    • Asbell P.A., Sahm D.F., 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.
    • (2008) J Cataract Refract Surg , vol.34 , pp. 814-818
    • Asbell, P.A.1    Sahm, D.F.2    Shaw, M.3
  • 38
    • 79952506792 scopus 로고    scopus 로고
    • Shifting trends in in vitro antibiotic susceptibilities for common bacterial isolates in the last decade at the New York Eye and Ear Infirmary [E-pub ahead of print: June 8, Graefes Arch Clin Exp Ophthalmol.
    • Adebayo A, Parikh JG, McCormick SA, et al. Shifting trends in in vitro antibiotic susceptibilities for common bacterial isolates in the last decade at the New York Eye and Ear Infirmary [E-pub ahead of print: June 8, 2010]. Graefes Arch Clin Exp Ophthalmol.
    • (2010)
    • Adebayo, A.1    Parikh, J.G.2    McCormick, S.A.3
  • 39
    • 34447621598 scopus 로고    scopus 로고
    • Spectrum of eye disease caused by methicillin-resistant Staphylococcus aureus
    • Freidlin J., Acharya N., Lietman T.M., et al. Spectrum of eye disease caused by methicillin-resistant Staphylococcus aureus. Am J Ophthalmol 2007, 144:313-315.
    • (2007) Am J Ophthalmol , vol.144 , pp. 313-315
    • Freidlin, J.1    Acharya, N.2    Lietman, T.M.3
  • 40
    • 33947686663 scopus 로고    scopus 로고
    • Methicillin-resistant Staphylococcus aureus infections of the eye and orbit (an American Ophthalmological Society thesis)
    • Blomquist H.P. Methicillin-resistant Staphylococcus aureus infections of the eye and orbit (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc 2008, 104:322-345.
    • (2008) Trans Am Ophthalmol Soc , vol.104 , pp. 322-345
    • Blomquist, H.P.1
  • 41
    • 77955581626 scopus 로고    scopus 로고
    • Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: Data from six clinical and phase I safety studies
    • Comstock T.L., Paterno M.R., Decory H.H., Usner D.W. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: Data from six clinical and phase I safety studies. Clin Drug Investig 2010, 30:675-685.
    • (2010) Clin Drug Investig , vol.30 , pp. 675-685
    • Comstock, T.L.1    Paterno, M.R.2    Decory, H.H.3    Usner, D.W.4
  • 42
    • 33746884732 scopus 로고    scopus 로고
    • Lippincott Williams & Wilkins, Philadelphia, Pa
    • Drug Facts and Comparisons 2008 2007, Lippincott Williams & Wilkins, Philadelphia, Pa.
    • (2007) Drug Facts and Comparisons 2008
  • 43
    • 0034871011 scopus 로고    scopus 로고
    • A systematic review of the associations between dose regimens and medication compliance
    • Claxton A.J., Cramer J., Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001, 23:1296-1310.
    • (2001) Clin Ther , vol.23 , pp. 1296-1310
    • Claxton, A.J.1    Cramer, J.2    Pierce, C.3
  • 44
    • 44449148293 scopus 로고    scopus 로고
    • The impact of medication regimen factors on adherence to chronic treatment: A review of literature
    • Ingersoll K.S., Cohen J. The impact of medication regimen factors on adherence to chronic treatment: A review of literature. J Behav Med 2008, 31:213-224.
    • (2008) J Behav Med , vol.31 , pp. 213-224
    • Ingersoll, K.S.1    Cohen, J.2
  • 45
    • 0041384468 scopus 로고    scopus 로고
    • The impact of reducing dose frequency on health outcomes
    • Richter A., Anton S.E., Koch P., Dennett S.L. The impact of reducing dose frequency on health outcomes. Clin Ther 2003, 25:2307-2335.
    • (2003) Clin Ther , vol.25 , pp. 2307-2335
    • Richter, A.1    Anton, S.E.2    Koch, P.3    Dennett, S.L.4
  • 46
    • 37349094346 scopus 로고    scopus 로고
    • Update on bacterial conjunctivitis in South Florida
    • Cavuoto K., Zutshi D., Karp C.L., et al. Update on bacterial conjunctivitis in South Florida. Ophthalmology 2008, 115:51-56.
    • (2008) Ophthalmology , vol.115 , pp. 51-56
    • Cavuoto, K.1    Zutshi, D.2    Karp, C.L.3
  • 47
    • 19344374675 scopus 로고    scopus 로고
    • Antimicrobial resistance determinants and future control
    • Harbarth S., Samore M.H. Antimicrobial resistance determinants and future control. Emerg Infect Dis 2005, 11:794-801.
    • (2005) Emerg Infect Dis , vol.11 , pp. 794-801
    • Harbarth, S.1    Samore, M.H.2
  • 48
    • 3843150553 scopus 로고    scopus 로고
    • The role of PK/PD parameters to avoid selection and increase of resistance: Mutant prevention concentration
    • Blondeau J.M., Hansen G., Metzler K., Hedlin P. The role of PK/PD parameters to avoid selection and increase of resistance: Mutant prevention concentration. J Chemother 2004, 16(Suppl 3):1-19.
    • (2004) J Chemother , vol.16 , Issue.SUPPL. 3 , pp. 1-19
    • Blondeau, J.M.1    Hansen, G.2    Metzler, K.3    Hedlin, P.4
  • 49
    • 0032926818 scopus 로고    scopus 로고
    • Antiseptics and disinfectants: Activity, action, and resistance [published correction appears in Clin Microbiol Rev. 2001;14:227]
    • McDonnell G., Russell A.D. Antiseptics and disinfectants: Activity, action, and resistance [published correction appears in Clin Microbiol Rev. 2001;14:227]. Clin Microbiol Rev 1999, 12:147-179.
    • (1999) Clin Microbiol Rev , vol.12 , pp. 147-179
    • McDonnell, G.1    Russell, A.D.2
  • 50
    • 34247869622 scopus 로고    scopus 로고
    • Antimicrobial efficacy of gatifloxacin and moxifloxacin with and without benzalkonium chloride compared with ciprofloxacin and levofloxacin against methicillin-resistant Staphylococcus aureus
    • Blondeau J.M., Boros S., Hesje C.K. 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.
    • (2007) J Chemother , vol.19 , pp. 146-151
    • Blondeau, J.M.1    Boros, S.2    Hesje, C.K.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.