Methods |
Design: three group, three period cross‐over trial
Purpose: study the effect of oral antioxidant therapy on marginal dry eye |
Participants |
Patients: out‐patients with marginal dry eyes |
Interventions |
Placebo: capsules without antioxidants
Untreated: no capsules
Experimental: capsules with antioxidants
(Co‐intervention: NS ) |
Outcomes |
Glasgow Caledonian University threads phenol read thread test (G‐CUT)
Tear thinning time
McMonnies dry eye questionnaire
Squamous cell metaplasia
Goblet cell density |
Notes |
The outcome data from this cross‐over trial was not available from the first period only, and was calculated as deriving from a parallel group trial. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
'Latin squares' |
Allocation concealment? |
Unclear risk |
No stated |
Blinding?
Treatment provider |
Low risk |
'This trial was double‐masked...' |
Blinding?
Outcome assessor |
Unclear risk |
NS |
Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
Free of selective reporting? |
Unclear risk |
No protocol available |
Free of other bias? |
Unclear risk |
The outcome data from this cross‐over trial was not available from the first period only, and was calculated as deriving from a parallel group trial. |
No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
Trial size > 49? |
Low risk |
N = 80 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |