NCT00241280.

Study characteristics
Methods	Study design: RCT, parallel‐group design Numbers randomized (total and per group): total 501 participants; 247 in Etafilcon A, 254 in Galyfilcon A group Unit of randomization: person Masking: double (participant, investigator) Exclusions and losses to follow‐up (total and per group): total 118 participants; 48 in Etafilcon A, 68 in Galyfilcon A group 11/48 participants in Etafilcon A not completed giving "comfort" as reason 16/68 participants in Galyfilcon A not completed giving "comfort" as reason Number analyzed (total and per group): VA outcome: total 385 participants (770 eyes); 199 (398 eyes) in Etafilcon A, 186 (372 eyes) in Galyfilcon A group safety outcome: total 501 participants; 247 in Etafilcon A, 254 in Galyfilcon A group Unit of analysis (person or eye): person and eye Study duration (planned and actual): 52 weeks Intervention duration: 52 weeks How were missing data handled: not reported Sample size and power calculation: not reported
Participants	Country: USA Setting: multicenter (25 sites) in university hospital and private practices Inclusion criteria: at least 18 years of age; minimum of 7 days successful lens wear; contact lens prescription requiring between −1.00 to −6.00 D spherical power; less than 1.00 D of astigmatism in either eye Exclusion criteria: not reported Baseline characteristics Refractive condition: myopia Etafilcon A (N = 247) women (n, %): 150 (60.7%) age (mean, SD, range): 31.7 (18 to 51) years race/ethnicity (n, %): predominantly white, 203 (82.2%) habitual wearers (n, %): not reported Galyfilcon A (N = 254) women (n, %): 172 (67.7%) age (mean, SD, range): 32.8 (18 to 60) years race/ethnicity (n, %): predominantly white, 217 (85.4%) habitual wearers (n, %): not reported Overall (N = 501) women (n, %): 322 (64.3%) age (mean, SD, range): 32.3 ± 6.3 (18 to 60) years (calculated) race/ethnicity (n, %): predominantly white, 420 (83.8%) habitual wearers (n, %): not reported
Interventions	Etafilcon A material: hydrogel replacement frequency: 7 days/6 nights Galyfilcon A material: silicone hydrogel replacement frequency: 7 days/6 nights
Outcomes	Primary outcome: percentage of participant eyes reported with Snellen VA worse than 20/40 at each study visit incidence of rates of contact lens‐related serious and significant adverse events (if there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic) Secondary outcomes: not specified Adverse outcomes (Y/N), if yes, please describe: incidence of rates of contact lens‐related serious and significant adverse events Measurement time points: baseline, 24 hours, 1, 4, 12, 24, 36, and 52 weeks
Notes	Sponsorship source: Johnson & Johnson Vision Care Inc. Author's name: David C Turner, PhD Institution: Johnson & Johnson Vision Care Inc. Conflicts of interest: not reported Publication language: English Trial register:NCT00241280