Methods |
Allocation method: randomised
Masking: double
Number of centres: one
HSV isolation (conjunctiva): 24 positive of 32 tested |
Participants |
Country: France
Number enrolled: 32
Average age (range): 49 (8‐77)
Sex: 19 males, 13 females
Inclusion criteria: dendritic epithelial keratitis |
Interventions |
Treatment one (n=16): acyclovir 3% ointment 4 times per day and placebo ointment 3 times per day
Treatment two (n=16): acyclovir 3% ointment 4 times per day and vidarabine 3% ointment 3 time per day |
Outcomes |
'The absence of fluorescein staining in the area of previous corneal ulceration' |
Notes |
Nonstudy interventions: none
Report language: English
Study date: not given
Financial support: governmental agency
Adverse reactions (Quote): "Diffuse superficial punctate epitheliopathy was noted in four patients (two in each group)...and resolved after the treatment was discontinued." |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
The investigators describe a random component in the sequence generation process |
Allocation concealment (selection bias) |
Low risk |
Quote: "The coded treatment were randomly allocated by the pharmacist." |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Quote: "All patients were examined by one ophthalmologist (JC), who did not know whether the patient was receiving vidarabine or placebo." |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No missing primary outcome data |
Selective reporting (reporting bias) |
Low risk |
The pre‐specified primary outcome was adequately reported |
Other bias |
Low risk |
The study appears to be free of other sources of bias |