Methods | Study design: randomized, parallel‐group study Conditions included: blepharitis and blepharoconjunctivitis Enrollment: 464 participants from multiple, international specialist eye centers Exclusions and loss to follow‐up: 220 participants who were culture‐negative on day 0 and did not complete follow‐up were excluded from the efficacy analyses Study follow‐up: 7 days |
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Participants | Countries: Europe and North America Age: mean 61 years (range 18 to 80 years) Gender: 217 men and 247 women Inclusion criteria: patients with blepharitis or blepharoconjunctivitis with presumed bacterial origin Exclusion criteria: 1) history of allergy to components of medications, 2) treatment with an antimicrobial agent or steroid in previous 48 hours, 3) pregnancy, 4) refusal to stop wearing contact lenses during study period, 5) meibomian disease, 6) frank marginal ulceration or severe pseudomembranous conjunctivitis |
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Interventions | Ciprofloxacin (n = 230): 0.3% ciprofloxacin eyedrops, starting with 1 or 2 drops every 2 hours for the first 48 hours and followed by 2 drops every 4 hours from days 2 to 6 Tobramycin (n = 234): 0.3% tobramycin eyedrops, starting with 1 or 2 drops every 2 hours for the first 48 hours and followed by 2 drops every 4 hours from days 2 to 6 All participants: nightly lid scrubs |
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Outcomes | Primary outcomes: 1) change in clinical assessment (cured, better, unchanged, worse) 2) changes in clinical signs and symptoms 3) change in bacteriologic assessment (eradication, reduction, persistence, proliferation) 4) clinical adverse events Measurements taken at baseline and day 7 Unit of analysis: the individual, using the worse eye in cases of bilateral disease |
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Notes | Study dates: not reported Funding source: not reported Declarations of interest: none reported Publication language: English |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomization not reported. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not reported. |
Masking (performance bias and detection bias) Were participants masked to treatment group? | Unclear risk | Reported as double‐masked, but details of masking not reported. |
Masking (performance bias and detection bias) Were healthcare providers masked to treatment group? | Unclear risk | Reported as double‐masked, but details of masking not reported. |
Masking (performance bias and detection bias) Were outcome assessors masked to treatment group? | Unclear risk | Reported as double‐masked, but details of masking not reported. |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT analysis was not followed. |
Selective reporting (reporting bias) | Low risk | Results were reported for primary and secondary outcomes. |
Other bias | Unclear risk | Included participants with blepharitis or blepharoconjunctivitis. |