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Antibiotics versus placebo for acute bacterial conjunctivitis

  1. Aziz Sheikh1,*,
  2. Brian Hurwitz2,
  3. Constant Paul van Schayck3,
  4. Susannah McLean4,
  5. Ulugbek Nurmatov5

Editorial Group: Cochrane Eyes and Vision Group

Published Online: 12 SEP 2012

Assessed as up-to-date: 18 JUL 2012

DOI: 10.1002/14651858.CD001211.pub3

How to Cite

Sheikh A, Hurwitz B, van Schayck CP, McLean S, Nurmatov U. Antibiotics versus placebo for acute bacterial conjunctivitis. Cochrane Database of Systematic Reviews 2012, Issue 9. Art. No.: CD001211. DOI: 10.1002/14651858.CD001211.pub3.

Author Information

  1. 1

    The University of Edinburgh, Centre for Population Health Sciences, Edinburgh, UK

  2. 2

    King's College London, London, UK

  3. 3

    Maastricht University, Department of General Practice, Maastricht, Netherlands

  4. 4

    The University of Edinburgh, Allergy & Respiratory Research Group, Centre for Population Health Sciences, Edinburgh, Scotland, UK

  5. 5

    Centre for Population Health Sciences, The University of Edinburgh, Allergy & Respiratory Research Group, Edinburgh, UK

*Aziz Sheikh, Centre for Population Health Sciences, The University of Edinburgh, Medical School, Doorway 3, Teviot Place, Edinburgh, EH8 9AG, UK. Aziz.Sheikh@ed.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 12 SEP 2012

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Characteristics of included studies [ordered by study ID]
Abelson 2008

MethodsRandomised controlled trial, double-masked

Method of randomisation: centrally randomised

Randomisation in block format, an equal probability randomisation procedure was employed


ParticipantsCountry: USA

Setting: specialist care

Participants recruited from clinical centres

Number of randomised: 279 patients

Age: 1 to 96 years

Gender: not reported

Ethnicity: not reported

Inclusion criteria: the diagnosis was confirmed on the basis of a best–corrected visual acuity (BCVA) score of 20/100 or better in each eye; a minimum score of 1 (on a scale from 0 (absent/normal) to 3 (severe)) for ocular discharge and either bulbar or palpebral conjunctival injection in the same eye

Exclusion criteria: debilitating disease, prior or concomitant use of any antibiotic or topical ophthalmic solution, suspected viral or allergic conjunctivitis, or positive pregnancy test results


InterventionsTreatment: 1% azithromycin in DuraSite

Control: vehicle


OutcomesClinical resolution and bacterial eradication at visit 3 (day 6 or 7); safety data; compliance


NotesAdequately powered study


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk“were randomised in block format”; “an equal probability randomization procedure was used.”

Allocation concealment (selection bias)Low risk“vehicle was identically supplied and formulated except that it contained no azithromycin”

Blinding of participants and personnel (performance bias)
All outcomes
Low risk“study personnel and participants were masked from their treatment assignments”

Blinding of outcome assessment (detection bias)
All outcomes
Low risk"only the study statistician and data-monitoring committee saw unmasked data, but these team members did not have any contact with study participants"

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk“more than twice as many in the vehicle group were discontinued early because of lack of efficacy?” (bias)

Selective reporting (reporting bias)High riskOnly results for “per-protocol” group of 279

Other biasHigh riskReporting, selection bias

Gigliotti 1984

MethodsRandomised controlled trial, double-masked
Coding of trial medication was carried out by Burroughs Wellcome
Method of randomisation: not described


ParticipantsCountry: USA
Setting: specialist care
Participants recruited from a paediatric practice, hospital paediatric clinic and a hospital walk-in clinic
Number randomised: 66 children
Age: 1 month to 18 years
Gender: not reported
Ethnicity: not reported
Inclusion criteria: swab-proven Haemophilus influenzae or Streptococcus pneumoniae and the presence of conjunctival inflammation or exudate
Exclusion criteria: history suggestive of allergy; history of trauma; foreign body in eye; use of antibiotics within the preceding week


InterventionsTreatment: ophthalmic ointment containing 10,000 U/gm polymyxin and 500 U/gm bacitracin 4 times daily for 7 days
Control: ointment vehicle without antibiotic


OutcomesEarly (days 3 to 5) and late (days 8 to 10) clinical and microbiological cure; symptoms reported by parents; compliance


NotesThere were 3 arms to this study: topical antibiotic, topical placebo and systemic antibiotics. As participants were allocated to the systemic antibiotic arm in a non-random method these participants have not been included in this review. Although symptoms reported by the participants were recorded these were not analysed by the authors.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk“randomised” but no details were given

Allocation concealment (selection bias)Unclear risk“numbered multidose tube, code was broken when the study was terminated”

Blinding of participants and personnel (performance bias)
All outcomes
Low riskRandomised, double-masked trial

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
High riskPatients who failed to return for final follow-up were not included in intention-to-treat analysis and missing data were not addressed

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasHigh riskPopulation bias; no baseline data on age, sex or race between groups

Gross 2003

MethodsRandomised, multicentre, double-masked, parallel-group trial

Method of randomisation: insufficient information

“Randomised” but no details; insufficient information


ParticipantsCountry: USA

Setting: specialist care

Participants recruited from clinical centres

Number of randomised: 73 patients

Age: 1 to 89 years

Gender: male = 37%; female = 63%

Ethnicity: Caucasian = 86.3%; African-American = 8.2%; Other = 5.5%

Inclusion criteria: “All patients had to have a rating of 1 (mild) or greater on a scale of 0 to 3 (absent to severe) for conjunctival discharge/exudates; patients ≤ 5 years of age a rating of at least 1 (mild) on a scale of 0 to 3 (normal to severe) for bulbar conjunctival injection, and patients > 5 years of age a rating of at least 2 for bulbar conjunctival injection. Only “culture-positive” patients were included in the evaluation of efficacy

Exclusion criteria: no detailed information


InterventionsTreatment: 0.5% moxifloxacin

Control: vehicle


OutcomesClinical resolution and bacterial eradication at visit on day 7 test–of-cure (TOC); safety data


Notes22 patients are omitted from reports and information about loss to follow-up not given


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk“randomised” but no details; insufficient information

Allocation concealment (selection bias)Low risk“seal envelope with treatment code”

Each investigator received a sealed envelope containing the description of the study medication assigned to each patient number

Blinding of participants and personnel (performance bias)
All outcomes
Low risk“double masked”; "investigators and staff masked as to treatment group”

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
High riskWhat happened to patients who were not culture-positive in analysis is unclear; missing data not addressed

Selective reporting (reporting bias)High riskLoss to follow-up

Other biasHigh riskSelection bias

Karpecki 2009

MethodsRandomised controlled trial, double-masked, vehicle-controlled

Method of randomisation: centrally randomised

Randomisation was performed using customised software


ParticipantsCountry: USA

Setting: specialist care

Participants recruited from clinical centres

Number of randomised: 269 patients

Age: 1 to 92 years

Gender: besifloxacin group - female 62.8%; male 37.2%; vehicle group – female 57.6%; male 42.4%

Ethnicity: besifloxacin group - white 84.7%; Hispanic 8.8%; black 4.4%; other 2.2%; vehicle group - white 80.3%; Hispanic 6.1%; black 8.3%; other 5.3%

Inclusion criteria: at least 1 year of age; a minimum of grade 1 for purulent conjunctival discharge (crusty or sticky eyelids) and a minimum of grade 1 for either bulbar or palpebral conjunctival injection in at least 1 eye on ocular examination; pinhole visual acuity ≥ 20/200 in each eye, a negative result on pregnancy testing

Exclusion criteria: hypersensitivity to fluoroquinolones, besifloxacin ophthalmic suspension; patients who used topical ophthalmic anti-inflammatory agents or solutions (artificial tears) within 48 hours before or during the study; suspected viral or allergic conjunctivitis, iritis; a history of recurrent corneal erosion syndrome, ulcerative active keratitis


InterventionsTreatment: 0.6% besifloxacin ophthalmic suspension

Control: vehicle


OutcomesClinical resolution and microbiological efficacy of besifloxacin; safety data; compliance


NotesAdequately powered study; this study was conducted at 35 centres in the United States


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation was performed using customised software in blocks

Allocation concealment (selection bias)Low risk“coded by packaging site”

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"patients were given their randomised study medication, which was coded by the packaging site"

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskWhether different investigators assessed the outcomes is unclear

Incomplete outcome data (attrition bias)
All outcomes
High riskThere was a statistically significant difference in withdrawal rates between groups

Selective reporting (reporting bias)High riskClinical resolution was assessed only in culture-proven patients; selective reporting

Other biasHigh riskSelective reporting; interpretation and presentation bias

Leibowitz 1991

MethodsRandomised controlled study, double-masked
Method of randomisation: not described


ParticipantsCountry: USA
Setting: specialist care
Participants recruited from hospital clinic
Number randomised: 177 patients randomised: 140 in the ciprofloxacin arm and 37 in the placebo arm
Age and gender: not reported
Ethnicity: not reported
Inclusion criteria: swab-proven conjunctivitis
Exclusion criteria: antibiotics or anti-inflammatory medication during the preceding 48 hours


InterventionsTreatment: ciprofloxacin 0.3% 1 to 2 drops into affected eye every 2 hours whilst awake on days 0 and 1, and every 4 hours whist awake on day 2
Control: ciprofloxacin vehicle


OutcomesRepeat swabs were taken on day 3, at least 12 hours after the last dose of medication
Outcomes: pathogen eradication; pathogen reduction; pathogen persistence; pathogen proliferation


NotesProxy outcome measures


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information

Allocation concealment (selection bias)Unclear risk“Double masked”, “coded medication?”; insufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskTable provided of why patients were excluded but this may affect results

Selective reporting (reporting bias)Low riskAll outcomes are completed

Other biasHigh riskOnly 288 patients “met all clinical criteria for study evaluation”

Miller 1992

MethodsRandomised controlled study, double-masked
Method of randomisation: not described


ParticipantsCountries: USA, Mali and Morocco
Setting: specialist care
Participants appear to have been recruited from hospital centres
Number randomised: 284 participants randomised (143 in antibiotic arm and 141 in placebo arm)
Age: greater than 18 years with mean of 38 years in both arms
Gender: 73 (51%) female in antibiotic arm and 86 (61%) female in placebo arm
Ethnicity: 75% Caucasian in either arm
Inclusion criteria: clinical diagnosis of acute bacterial conjunctivitis or blepharoconjunctivitis, with the presence of conjunctival hyperaemia
Exclusion criteria: conjunctivitis due to Neiserria gonorrhoeae, a sensitivity to quinolones or benzalkonium chloride, or those who had received topical antibacterial agents in the preceding 48 hours


InterventionsTreatment: norfloxacin 0.3% + 0.0025% benzalkonium chloride preservative, 1 drop into each affected eye every 2 hours of the waking day for the first day, and then 4 times a day for a maximum of 7 days
Control: 0.01% benzalkonium chloride


OutcomesGlobal clinical outcome: cured (signs and symptoms of infection clear), improved (signs and/or symptoms still present but of less severity), no change or worsened
Microbiological outcome was categorised as: pathogen eradication, pathogen suppression or pathogen persistence
Clinical outcomes were recorded at days 2 to 3; microbiological outcomes were recorded at days 2 to 3 and days 5 to 7
All symptoms and signs were recorded, specifically including: symptoms of blurred vision, eye burning, foreign body sensation, photophobia, tearing and itching of eye; signs of conjunctival hyperaemia, discharge, oedema and follicles, active infiltrates and corneal staining with fluorescein, lid oedema and exudates


NotesThe following symptoms were reported to be significantly better (although data are not presented) at day 2 to 3: burning eye and foreign body sensation. This significant improvement was not maintained at the day 5 to 7 assessment. The following signs were reported to be significantly better at the day 2 to 3 assessment (although individual data are not presented): discharge, chemosis, hyperaemia and lid oedema. This significant improvement was not maintained at the day 5 to 7 assessment.
Subgroup analysis for Type A organisms (Staphylococcus aureus, Streptococcus or Gram-negative organisms)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk“randomised” but no details given

Allocation concealment (selection bias)Low risk“identical plastic dropper vials”

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
High riskSignificantly more placebo patients discontinued treatment for lack of improvement

Selective reporting (reporting bias)High riskSelection made according to bacteria grown

Other biasHigh risk“bias due to early stopping”

Rietveld 2005

MethodsRandomised controlled trial, double-masked
Method of randomisation: centrally randomised


ParticipantsCountry: Holland
Setting: primary care
Number randomised: 181
Age: mean age 41 (14.6) in the placebo arm and 45 8 (14.7) in the antibiotic arm
Gender: 59% female
Ethnicity: not recorded
Inclusion criteria: red eye and either mucopurulent discharge or sticking of the eyelids
Exclusion criteria: age younger than 18, pre-existing symptoms longer than 7 days, acute loss of vision, wearing of contacts, systemic or local antibiotic use within the previous 2 weeks ciliary redness, eye trauma and a history of eye operation


InterventionsTreatment: fusidic acid gel 1% 4 times daily over a week
Control: placebo


OutcomesPatient-assessed cure, confirmed by clinician assessment


NotesAdequately powered study; external validity questionable


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomisation lists

Allocation concealment (selection bias)Low riskThe study medication was repacked into identical tubes by a local pharmacist

Blinding of participants and personnel (performance bias)
All outcomes
Low riskThe GPs and patients received coded tubes

Blinding of outcome assessment (detection bias)
All outcomes
Low risk"The pharmacist was the only person in possession of the randomisation lists and was not involved in outcome measurement or data analysis"

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll outcomes are reported

Selective reporting (reporting bias)Low riskNo reporting bias

Other biasLow riskNo other bias

Rose 2005

MethodsRandomised controlled trial, double-masked
Method of randomisation: centrally randomised


ParticipantsCountry: UK
Setting: primary care
Number randomised: 326
Age: 6 months to 12 years
Gender: 52% male
Ethnicity: not reported
Inclusion criteria: working clinical diagnosis of acute infective conjunctivitis
Exclusion criteria: known allergy to chloramphenicol, current antibiotic or antibiotic treatment within the previous 48 hours, immunocompromised or evidence of server infection (e.g. periorbital cellulitis)


InterventionsTreatment: chloramphenicol 0.5%
Control: placebo


OutcomesParent-assessed cure as recorded in daily diary


NotesAdequately powered study


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomisation code was employed

Allocation concealment (selection bias)Low riskIdentical bottles prepared externally

Blinding of participants and personnel (performance bias)
All outcomes
Low riskPatients and personnel were masked

Blinding of outcome assessment (detection bias)
All outcomes
Low risk"the main analysis was undertaken before the randomisation code was broken"

Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention-to-treat analysis performed as if those lost to follow-up were treatment failures

Selective reporting (reporting bias)Low riskAll outcomes were reported

Other biasLow riskNo other bias

Silverstein 2011

MethodsRandomised controlled trial, double-masked, vehicle-controlled

Method of randomisation: centrally randomised

Randomisation: a computer-generated randomisation schedule was used in a 1:1 ratio


ParticipantsCountry: USA

Setting: specialist care

Participants recruited from clinical centres

Number of randomised: 202 patients

Age: 1 to 86 years

Gender: besifloxacin group - female 58.8%; male 41.2%; vehicle group – female 55.2%; male 44.8%

Ethnicity: besifloxacin group - not Hispanic 68.0%; Hispanic 30.9%; missing data 1%; vehicle group - not Hispanic 73.3%; Hispanic 26.7%; missing data 0%

Inclusion criteria: at least 1 year of age; a minimum of grade 1 for purulent conjunctival discharge (crusty or sticky eyelids) and a minimum of grade 1 for either bulbar or palpebral conjunctival injection in at least 1 eye on ocular examination; pinhole visual acuity ≥ 20/200 in each eye, a negative result on pregnancy testing

Exclusion criteria: hypersensitivity to fluoroquinolones, besifloxacin ophthalmic suspension; if patients required or had used ocular immunosuppressants within 30 days before the start of the study; suspected viral or allergic conjunctivitis, iritis; a history of recurrent corneal erosion syndrome, ulcerative active keratitis


InterventionsTreatment: 0.6% besifloxacin ophthalmic suspension

Control: vehicle


OutcomesClinical resolution and microbiological efficacy of besifloxacin; safety data; compliance


NotesBesifloxacin was given twice daily for 3 days only


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCentrally computer-generated randomisation code was employed

Allocation concealment (selection bias)Low riskMasked kits were packaged in identical white plastic bottles

Blinding of participants and personnel (performance bias)
All outcomes
Low risk“the investigator was not present during first installation; therefore both patient and investigator were blinded"

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
High risk202 patients randomised and had treatment; only 109 patients' data for clinical resolution were reported

Selective reporting (reporting bias)High riskClinical intention-to-treat population analysis made according to culture-positive patients (n = 109), although all 202 patients had treatment

Other biasHigh riskSelection, reporting bias

Tauber 2011

MethodsRandomised controlled trial, double-masked, vehicle-controlled

Method of randomisation: unclear

Randomisation: eligible patients were randomised in a 1:1 ratio


ParticipantsCountry: USA

Setting: specialist care

Number of randomised: 847 patients

Age: > 28 days old

Gender: MOXI-AF group - female 59.5%; male 40.5%; vehicle group – female 57.7%; male 42.3%

Ethnicity: MOXI-AF group - Hispanic, Latino or Spanish 23.8.0%; not Hispanic, Latino or Spanish 76.2%; vehicle group - Hispanic, Latino or Spanish 25.9.0%; not Hispanic, Latino or Spanish 74.1%

Inclusion criteria: at least 28 days old; a minimum of grade 1 for purulent conjunctival discharge (crusty or sticky eyelids) and a minimum of grade 1 for either bulbar or injection in one or both eyes

Exclusion criteria: if signs and symptoms of bacterial conjunctivitis had began longer than 4 days prior to the first visit


InterventionsTreatment: an alternative formulation of 0.5% moxifloxacin ophthalmic solution (MOXI-AF)

Control: vehicle


OutcomesMicrobiological efficacy of MOXI-AF; safety data; compliance


NotesOnly microbiological outcomes were reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low risk“to maintain masking, specifically designated site personnel other than the study investigator instilled the first dose of medication at the day 1 visit”

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Low risk“microbiological intent-to-treat population" – MITT (427 treated with MOXI-AF and 423 with vehicle) was done

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNo other bias

Tepedino 2009

MethodsRandomised controlled trial, double-masked, vehicle-controlled

Method of randomisation: centrally randomised

Randomisation: a computer-generated randomisation schedule was used in a 1:1 ratio


ParticipantsCountry: USA

Setting: specialist care

Participants recruited from clinical centres

Number of randomised: 957 patients

Age: 1 to 98 years

Gender: besifloxacin group - female 63.6%; male 36.4%; vehicle group – female 62.2%; male 37.8%

Ethnicity: besifloxacin group - American Indian/Alaskan Native 0.2%; Asian 2.1%; Black 9.3%; Native Hawaiian/Pacific Islander 0.2%; white 65.7%; other 22.5%;  vehicle group - American Indian/Alaskan Native 0.2%; Asian 1.5%; Black 9.5%; Native Hawaiian/Pacific Islander 0.6%; white 64.7%; other 23.4%

Inclusion criteria: at least 1 year of age; a minimum of grade 1 for purulent conjunctival discharge (crusty or sticky eyelids) and a minimum of grade 1 for either bulbar or palpebral conjunctival injection in at least 1 eye on ocular examination; pinhole visual acuity ≥ 20/200 in each eye, a negative result on pregnancy testing

Exclusion criteria: hypersensitivity to fluoroquinolones, besifloxacin ophthalmic suspension; patients who used topical ophthalmic anti-inflammatory agents or solutions (artificial tears) within 48 hours before or during the study; suspected viral or allergic conjunctivitis, iritis; a history of recurrent corneal erosion syndrome, ulcerative active keratitis


InterventionsTreatment: 0.6% besifloxacin ophthalmic suspension

Control: vehicle


OutcomesClinical resolution and microbiological efficacy of besifloxacin; safety data; compliance


NotesAdequately powered study; this study was conducted at 58 sites in the United States between 5 June 2006 and 7 November 2007; a limitation of this study was the lack of a non-treatment control group


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomised in a 1:1 ratio stratified by investigative site; computer-generated

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskThere is no information about the preparation of active and vehicle solutions

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
High risk26 patients in ITT population discontinued, 8 with intervention and 18 placebo

Selective reporting (reporting bias)High riskWrong denominator for clinical resolution

Other biasHigh riskMisrandomisation

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Bremond-Gignac 2010Not a placebo-controlled trial

Denis 2008Not a placebo-controlled trial

Everitt 2006Not a placebo-controlled trial

Granet 2008Not a placebo-controlled trial

Leibowitz 1976Single-masked

McDonald 2009Not a placebo-controlled trial

Mitsui 1986No placebo group

Robert 2010Not a placebo-controlled trial

Szaflik 2009Not a placebo-controlled trial

Ta 2007Not a placebo-controlled trial

 
Characteristics of studies awaiting assessment [ordered by study ID]
NCT00509873

MethodsDouble-masked, placebo-controlled RCT

Participants

InterventionsGatifloxacin 0.5% eye drops versus placebo

OutcomesPercentage of patients with clearing (clinical success) of conjunctival hyperaemia and conjunctival discharge at day 6; percentage of patients with microbiological cure at day 6; percentage of patients with clinical improvement of ocular signs at day 6; percentage of patients with clinical improvement of ocular symptoms at day 6

Notes

NCT00518089

MethodsDouble-masked, placebo-controlled RCT

Participants

InterventionsGatifloxacin 0.5% eye drops versus placebo

OutcomesPercentage of patients with clearing (clinical success) of conjunctival hyperaemia and conjunctival discharge at day 6; percentage of patients with microbiological cure at day 6; percentage of patients with clinical improvement of ocular signs at day 6; percentage of patients with clinical improvement of ocular symptoms at day 6

Notes

NCT01175590

MethodsDouble-masked, vehicle-controlled RCT

Participants

InterventionsBesivance versus vehicle

OutcomesTreatment-emergent adverse events; clinical resolution; microbial eradication; individual clinical outcomes; microbial outcome and clinical outcome; visual acuity

Notes

Ofloxacin 1990

MethodsDouble-masked, parallel group

ParticipantsCountry: USA

Number recruited: 132 patients

InterventionsLoxacin 0.3% eye drops versus placebo instilled 6 times daily for 2 days

OutcomesEfficacy and safety; microbial reinfection rate

Notes

 
Comparison 1. Antibiotics versus placebo

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Clinical remission (early)62116Risk Ratio (M-H, Random, 95% CI)1.36 [1.15, 1.61]

 2 Microbiological remission (early)71850Risk Ratio (M-H, Random, 95% CI)1.55 [1.37, 1.76]

 3 Clinical remission (late)82353Risk Ratio (M-H, Random, 95% CI)1.21 [1.10, 1.33]

 4 Microbiological remission (late)91456Risk Ratio (M-H, Random, 95% CI)1.37 [1.24, 1.52]

 
Table 1. Ingredients of eye drops

StudiesActive treatment ingredientPlacebo vehicle ingredient

Abelson 20081% azithromycin in DuraSite0.01% benzalkonium chloride (BAK), a potent antiseptic

Gigliotti

1984
Ointment containing polymyxin and bacitracinNeutral ointment

Gross 2003 and Tauber

2011
0.5% moxifloxacinNo information

Karpecki 2009; Tepedino 2009; and Silverstein 20110.6% besifloxacin0.01% benzalkonium chloride (BAK), a potent antiseptic

Leibowitz 19910.3% ciprofloxacinNo information

Miller 19920.3% norfloxacin0.01% benzalkonium chloride (BAK), a potent antiseptic

Rietveld 20051% fusidic acid gelPlacebo gel Vidisic 2 mg/g does not contain an antiseptic

Rose 20050.5% chloramphenicolBoric acid/borax - also has antiseptic properties