| Methods |
Allocation method: randomised
Masking: double
Number of centres: one |
| Participants |
Country: Netherlands
Number enrolled: 56
Average age (range): 46 (range not given)
Sex: 36 males, 20 females
Inclusion criteria: dendritic epithelial keratitis |
| Interventions |
Treatment one (n=28): vidarabine 3% ointment 5 times per day
Treatment two (n=28): trifluridine 2% ointment 5 times per day |
| Outcomes |
Fluorescein and rose‐Bengal staining; 'no epithelial edema and cystic changes were present in the epithelium covering the site of the original ulcer' |
| Notes |
Nonstudy interventions: scopolamine
Report language: English
Study date: not given
Financial support: not given
Adverse reactions (Quote): "In 5 out of 17 patients that received the virostatic treatment longer than 14 days a very mild diffuse epithelial staining was observed with Bengal rose. Four of these patients received ara‐A and 1 received treatment with TFT." |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Insufficient information. The investigators did not describe how the sequence generation process was developed |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Each patient received a coded treatment sequentially allocated by the central dispensing unit....The ointment tubes were identical in design." |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐masked trial design described |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "Seven out of 63 treated ulcers failed to heal within 23 days, which was our arbitrary limit. These cases were excluded from the analysis." |
| 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 |
