Hall 2009.

Study characteristics
Methods	Study design: RCT, parallel‐group design Numbers randomized (total and per group): total 248 participants; 127 in Narafilcon A and 121 in Nelfilcon A group Unit of randomization: person Masking: "single (participant)" Exclusions and losses to follow‐up (total and per group): total 5; 2 in Narafilcon A and 3 in Nelfilcon A group (1 participant in Nelfilcon A group was withdrawn due to adverse event) Number analyzed (total and per group): total 243 participants; 125 in Narafilcon A and 118 in Nelfilcon A group Unit of analysis (person or eye): person Study duration (planned and actual): 1 week Intervention duration: 1 week How were missing data handled: excluded Sample size and power calculation: not reported
Participants	Country: UK Setting: 21 sites Inclusion criteria: aged 18 years or older, willing to follow protocol, maximum of 1.00 D of refractive astigmatism; VA of 6/9 (20/30) in each eye with contact lenses, able to wear contact lenses with a back vertex power of −1.00 to −6.00 DS; successfully worn contact lenses within 6 months prior to enrollment Exclusion criteria: systemic disorders or ocular disorders (including surface signs) preventing contact lens wear; aphakic; corneal distortions (due to hard contact lens wear or keratoconus); using any topical medication (ointment, eye drops); previous corneal refractive surgery; infectious or immunosuppressive disease (hepatitis, HIV); diabetes; taken part in any other clinical trial 2 weeks prior to the start of the study Baseline characteristics Refractive condition: a maximum of 1.00 D of refractive astigmatism Narafilcon A (N = 125) women (n, %): 90 (72.0%) age (mean, SD): 33 ± 9.5 years race/ethnicity (n, %): not reported habitual wearers (n, %): not reported Nelfilcon A (N = 118) women (n, %): 92 (78.0%) age (mean, SD): 32.9 ± 10.6 years race/ethnicity (n, %): not reported habitual wearers (n, %): not reported Overall (N = 243) women (n, %): 182 (74.9%) age (mean, SD): 33.0 ± 10.0 years race/ethnicity (n, %): not reported habitual wearers (n, %): 104 (42%)
Interventions	Narafilcon A material: silicone hydrogel replacement frequency: daily Nelfilcon A material: hydrogel replacement frequency: daily
Outcomes	Primary outcomes: overall comfort (scale 0 to 5; 0 = not applicable, 1 = poor, 2 = fair, 3 = good, 4 = very good, 5 = excellent) measured limbal hyperemia graded using half‐grade increments (scale 0 to 4; 0 = none, 1 = trace, 2 = mild, 3 = moderate, 4 = severe) Secondary outcomes: overall handling end‐of‐day comfort initial comfort inferior region corneal staining Measurement time points: 1 week Notes: initial trial outcomes changed as indicated on the trial registry website
Notes	Sponsorship source: supported by Johnson & Johnson Vision Care Inc. Author's name: Lee Hall Institution: Visioncare Research Ltd. Conflicts of interest: not reported Publication language: English Trial register:NCT00727558