| Study |
Bias |
| Randomisation process |
Deviations from intended interventions |
Missing outcome data |
Measurement of the outcome |
Selection of the reported results |
Overall |
| Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
| Subgroup 1.7.1 ≤ 4 weeks |
| Diec 2012 |
Some concerns |
"Randomisation list will be generated from simple randomisation using randomisation computer software." The method of allocation concealment is not detailed. The authors reported no statistical differences in baseline characteristics. Neophytes were split equally across arms. It is not clear how they accounted for this in randomization. |
Low risk of bias |
The study was an open‐label, prospective clinical trial that included experienced and neophyte myopic participants randomized to one of three lens types, worn bilaterally. It does not seem like there were deviations due to the trial context. Proportions are reported as an intention‐to‐treat analysis. |
Low risk of bias |
7/140 participants discontinued. The adverse events and time points are noted. There are 6 discontinuations in Narafilcon A and 1 in Senofilcon A. |
Low risk of bias |
Although the investigators were aware of the interventions received by the participants, the severity of this outcome should not be easily missed or ignored. |
Low risk of bias |
The was no analytic plan for evaluation but the data for the outcome was analyzed and reported at the event level, as usual. |
Some concerns |
The study was judged to have some concerns associated with bias in process of the allocation concealment. |
| Hall 2009 |
Some concerns |
The authors did not describe details about the process of allocation concealment was performed if any at all. |
Low risk of bias |
The trial registration record stated 'single‐blind (participants)'. There was no evidence of deviations from the intended intervention. |
Low risk of bias |
Data for this outcome were available for nearly all participants (240/248 = 97%). |
Low risk of bias |
Participants were followed at the end of the one‐week wear and assessed by trial investigators (or study physicians) who were aware of the assigned intervention status. The severity of the outcome could not be easily missed or ignored though. |
Some concerns |
Adverse events were reported at the person level (with no events recorded). It was unclear how the reporting threshold (5%) was determined a priori. |
Some concerns |
The trial was judged to have some concerns in the randomization process and selective outcome reporting. |
| Subgroup 1.7.2 At 3 months |
| NCT01354223 |
Some concerns |
The authors only stated that it was randomized; details about allocation concealment were not described. |
Low risk of bias |
It was an open‐label (no masking) trial. There was no evidence for deviations from the intended intervention. |
Low risk of bias |
Data for this outcome was available for almost all eyes randomized (OcufilconB: 58/60 eyes, Stenfilcon A: 114/120 eyes). |
Low risk of bias |
It was unclear how vision‐threatening adverse events were actively monitored by the investigators or passively by participants' self reporting. However, the severity of the outcome should not be easily ignored or missed. |
Some concerns |
Minimal information was provided regarding the measurement or the analysis plan though the reporting threshold for nonserious ocular adverse events was reported as 5%, suggesting potential risks for under‐reporting or selective reporting of the outcome. |
Some concerns |
The trial was judged to have some concerns in the randomization process and selective outcome reporting. |
| Subgroup 1.7.3 At 52 weeks |
| NCT00241280 |
High risk of bias |
Only states it was randomized. Randomization of lenses was very uneven. Two lenses only had 3 participants allocated and all 6 were lost to follow‐up. |
Some concerns |
No information on masking. Appears to be an intention‐to‐treat analysis with all participants included. |
Low risk of bias |
All participants appear to be included. |
High risk of bias |
There is insufficient information to determine whether there is bias in the measurement of the outcome. |
Some concerns |
No analysis plan provided. It is not clear how the frequency threshold (5%) was applied, whether there was a systematic and non systematic collected but only systematic above 5% reported. Not enough information to determine if this resulted in selection of the reported result. |
High risk of bias |
The trial was judged to be at high risk in the randomization process and in outcome measurement. There were also some concerns in selective outcome reporting. |
| NCT00762788 |
High risk of bias |
The authors did not provide details of randomization or allocation concealment but only stated the trial was 'randomized'. There appear to be post‐randomization exclusions labeled in the investigator's note: "Cautions for results: low completed enrollment numbers and number of non‐neophytes lower than required per protocol. Arms not gender matched; Proportion of neophytes/non‐neophytes not balanced; High rate of drop‐out among subjects enrolled." |
Low risk of bias |
The trial was described as single‐masked (investigator). There was no evidence for deviations from the intended interventions. |
High risk of bias |
Data for this outcome were reported for all participants. However, considering the large dropout rates, bias might have been introduced by imputing data for those who did not complete the study. |
Low risk of bias |
The trial was single‐masked (investigators). Measurement of this outcome was unlikely biased as the investigators had no knowledge about the intervention received by the participants. |
Low risk of bias |
No analysis plan was provided but the data were reported at both the person and event level. The data presented in ClinicalTrial.gov have significant and non‐signficant in different sections. |
High risk of bias |
The trial was judged to be at high risk in the randomization process followed by substantial lost to follow‐up after randomization. |
