Opthalmic Antibiotic‐Steroid Combination Agents
Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-945-5220 | Fax 503-947-1119
OpthalmicAntibiotic-SteroidCombinationAgents
Month/YearofReview:November2012
DateofLastReview:March2010
PDLClass:OpthalmicAntibiotics-steroidscombination
SourceDocument:ProviderSynergies(PS)
CurrentPreferredAgents
CurrentNon-PreferredAgents
Neo/polymyxBsulf/dexamethasonedrops
Fluometholone/sulfacetamide(FML-SLiquifilm?)drops
Neomysulf/bacitrac/poly/HCointment
Gentamicin/prednisolone(Pred-G?)0.3%/1%dropsand0.3%/0.6%ointment
SulfacetmNA/prednisolAC(BelphamideS.O.P?)ointment
Loprednol/tobromycin(Zylert?)drops
SulfacetmNA/prednisolAC(Blephamide?)drops
Tobramycinsulf/dexamethasonedrops
Tobramycinsulf/dexamethasone(Tobradex?)Ointment
PreviousRecommendations:
1. Thereisnodifferenceinefficacy/effectivenessorinsafetybetweenagents.(Strengthofrecommendation:C)
2. Thereisinsufficientevidencetomakeaspecificrecommendation.
PACriteria/QL:None
Recommendations: Nofurtherresearchorreviewneededatthistime. Background: Theuseofacombinationdrugwithanti-infectivecomponentisindicatedwheretheriskofsuperficialocularinfectionishighorwherethereisanexpectation thatpotentiallydangerousnumbersofbacteriawillpresentintheeye.
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Methods:
AMEDLINEOVIDsearchwasconductedusingallophthalmicantibiotics-steroidcombinationagentslimitedtorandomizedcontrolledtrialsandmeta-analysis,
Englishlanguage,andconductedinhumanssincetheliteraturesearchconductedforthepreviousPSreview.TheAgencyforHealthcareResearchandQuality
(AHRQ),CochraneCollection,andtheCanadianAgencyforDrugsandTechnologiesinHealth(CADTH)resourcesweresearchedforhighqualitysystematic
reviews.TheFDAwebsitewassearchedfornewdrugs,indications,andsafetyalerts,andtheAHRQNationalGuidelineClearinghouse(NGC)wassearchedfor
updatedandrecentevidence-basedguidelines.
NewTrials:
Atotalof36citationsresultedandafterreviewforinclusions,twopotentiallyrelevantclinicaltrialswereidentified(Appendix1).Thesetrialsarebriefly
describedinTable1.
Table1:PotentialRelevantNewTrials
Study BlairJ1,2011
Comparison Dexamethasone+
Population Overtheageof12years
PrimaryOutcome
Results
Residualulcersizeat10weeks Allsubjects(n=30)demonstrateda
RCT
gatifloxacincomparedwith withbacterialcornealulcer basedondigitalphotographs. reductioninulcersizeoverthestudy
gatifloxacin+Placebo
confirmedbyculture.
period.Therewasnosignificantdifference
betweenthe2groupsintermsofthe
TorkildsenGL2,
Tobramycin/dexamethasone Patientswithmoderateto Seven-itemglobalscore
primaryoutcome. Astatisticallysignificantlowermeanglobal
2011 RCT,MC, investigator-
(ST)comparedto azithromycin
severeblepharitis/ blepharoconjunctivitis.
definedasthetotalscoreoflid score(p=0.0002)wasobservedin
marginredness,bulbar
subjectstreatedwithSTcomparedto
conjunctivalredness,palpebral subjectstreatedwithazithromycinatDay
masked
conjunctivalredness,ocular discharge(0-3scale),andlid swelling,itchyeyelids,and grittyeyes(0-4scale).
8.Noseriousadverseeventswere reportedduringthecourseofthestudyin eithergroup.
RCT=Randomizedcontroltrial;MC=multi-center
Newdrugs:
Noneidentified.
NewFDAIndications:
Noneidentified.
NewFDAsafetyalerts:
Noneidentified.
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NewSystematicReviews: Noneidentified. Guidelines:
Noneidentified.
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References:
1.BlairJ,HodgeW,Al-GhamdiS,parisonofantibiotic-onlyandantibiotic-steroidcombinationtreatmentincornealulcerpatients:double-blindedrandomizedclinical trial.Can.J.Ophthalmol.2011;46(1):40?45. 2.TorkildsenGL,CockrumP,MeierE,etal.Evaluationofclinicalefficacyandsafetyoftobramycin/dexamethasoneophthalmicsuspension0.3%/0.05%comparedto azithromycinophthalmicsolution1%inthetreatmentofmoderatetosevereacuteblepharitis/blepharoconjunctivitis.CurrMedResOpin.2011;27(1):171?178.
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Appendix1
1. BlairJ,HodgeW,Al-GhamdiS,parisonofantibiotic-onlyandantibiotic-steroidcombinationtreatmentincornealulcerpatients:double-blindedrandomized clinicaltrial.Can.J.Ophthalmol.2011;46(1):40?45.
Objective:Todeterminethebenefitofearlyadditionofcorticosteroidstoantibioticsinthetreatmentofcornealulcers.
Participants:Thirtyeyesof30patients,overtheageof12years,withbacterialcornealulcerconfirmedbyculture.
Methods:Patientswererandomizedbeforeenrollment;15weretreatedwithgatifloxacin(Zymar)andamaskedplaceboandtheother15weretreatedwithgatifloxacin andmaskeddexamethasone0.1%(Maxidex).Primaryoutcomewasresidualulcersizeat10weeksbasedondigitalphotographs.Secondaryoutcomesincludedresidual ulcerareabyclinicianestimate,visualacuity,VF-14score,andtimetohealing.
Results:Allsubjects(n=30)demonstratedareductioninulcersizeoverthestudyperiod.Therewasnosignificantdifferencebetweenthe2groupsintermsoftheprimary outcome.Therewasasignificantdifferencebetweenthe2groupsin1ofthesecondaryoutcomes.Themeanresidualulcersizecomparedwiththebaselinebyclinician estimate(slit-lamp)was-0.789mm2fortheantibiotic-onlygroupand-4.206mm2fortheantibiotic-steroidgroup(p=0.05).Amongtheothersecondaryoutcomesthere werenosignificantdifferencesbetweenthe2groups.
Conclusions:Nobenefitwasdemonstratedinourprimaryoutcomeforusingsteroidsincombinationwithantibiotictherapyintreatmentofcornealulcers.Thisstudy suggeststhattheearlyadditionofsteroidstotheantibiotictreatmentofcornealulcersdoesnotseemtobeharmfulwhenemployedinacloselymonitoredclinicalsetting.
2. TorkildsenGL,CockrumP,MeierE,etal.Evaluationofclinicalefficacyandsafetyoftobramycin/dexamethasoneophthalmicsuspension0.3%/0.05%comparedto azithromycinophthalmicsolution1%inthetreatmentofmoderatetosevereacuteblepharitis/blepharoconjunctivitis.CurrMedResOpin.2011;27(1):171?178.
Objective:Toevaluatetheclinicalefficacyandsafetyoftobramycin/dexamethasone(TobraDexST;'ST')ophthalmicsuspension0.3%/0.05%comparedtoazithromycin (Azasite?)ophthalmicsolution(1%)inthetreatmentofmoderatetosevereblepharitis/blepharoconjunctivitis.
Researchdesignandmethods:Thestudywasamulticenter,randomized,investigator-masked,andactive-controlled,15-daystudy.Enrolledinthestudywere122adult subjects(atleast18yearsofage)diagnosedwithmoderatetosevereblepharitis/blepharoconjunctivitis,definedbyaminimumscoreofatleast'1'foroneofthelidsigns, oneoftheconjunctivalsigns,andoneofthesymptomsinatleastoneeyeandaminimumglobalscore(totalsignsandsymptomsscore)of'5'inthesameeye.Onegroupof 61subjectsreceivedSTwithinstructionstodose1dropfourtimesdaily(QID)for14days.Theothergroupof61subjectsreceivedazithromycinanddosedwith1drop twicedaily(BID)for2daysfollowedbyoncedaily(QD)dosingfor12days.VisitswereconductedatDay1(baseline),Day8andDay15.Theaprioriprimaryoutcome parameterofthestudywastheseven-itemglobalscoredefinedasthetotalscoreoflidmarginredness,bulbarconjunctivalredness,palpebralconjunctivalredness,ocular discharge(0-3scale),andlidswelling,itchyeyelids,andgrittyeyes(0-4scale).Thestudyutilizedstandardized,validatedphotographcontrolscalesdevelopedbyOra,Inc. (Andover,MA).Clinicaltrialregistration:undertheregistrynumberNCT01102244.
Results:Astatisticallysignificantlowermeanglobalscore(p=0.0002)wasobservedinsubjectstreatedwithSTcomparedtosubjectstreatedwithazithromycinatDay8. Noseriousadverseeventswerereportedduringthecourseofthestudyineithergroup.
Conclusion:STprovidesafastandeffectivetreatmentofacuteblepharitiscomparedtoazithromycin.Initialtherapywiththecombinationoftobramycin/dexamethasone providesfasterinflammationreliefthanazithromycinformoderatetosevereblepharitis/blepharoconjunctivitis.
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