NCT00762788.

Study characteristics
Methods	Study design: RCT, parallel‐group design Numbers randomized (total and per group): total 314 participants Unit of randomization: person Masking: single (investigator) Exclusions and losses to follow‐up (total and per group): total 144 participants (45.9%) lost to follow‐up Number analyzed (total and per group): total 314 participants analyzed for safety outcomes Unit of analysis (individual or eye): person Study duration (planned and actual): 52 weeks Intervention duration: 52 weeks How were missing data handled: assuming no adverse events incurred to those lost to follow‐up Sample size and power calculation: not reported
Participants	Country: India Setting: Vision Research Foundation in Chennai, Tamil Nadu, India Inclusion criteria: between 18 and 39 years of age; requires visual correction in both eyes; require a soft contact lens spherical correction between −0.50 and −9.00 D; have an astigmatic correction less than 1.50 D in both eyes; correctable to a VA of 20/30 or better in each eye; able to regularly wear the lenses on a 7‐day/6‐night extended wear basis (e.g. does not regularly swim more than once a week); no evidence of eye abnormality or disease (no amblyopia); no lid abnormality or infection; no clinically significant slit lamp findings; no previous ocular surgery Exclusion criteria: concurrent ocular medication; clinically significant slit lamp findings (grade 3 or 4); systemic illness or treatments that would contraindicate lens wear; diabetes; infectious disease (e.g. hepatitis, tuberculosis); immunosuppressive disease (e.g. HIV); hard contact lens wear in the previous 8 weeks; previous refractive surgery; injury/surgery within 8 weeks immediately prior to enrollment; keratoconus or other corneal irregularity; pregnancy, lactating or planning a pregnancy; participation in any concurrent clinical trial; currently wearing any of the study lenses on an extended wear basis; previous adverse events contraindicating extended wear (microbial keratitis, corneal scars) Baseline characteristics Refractive condition: myopia Senofilcon A (N = 55) women (n, %): 38 (69%) age (mean, SD): 21.1 ± 3.2 years race/ethnicity (n, %): not reported habitual wearers (n, %): not reported Lotrafilcon A (N = 58) women (n, %): 31 (53%) age (mean, SD): 21.6 ± 4.9 years race/ethnicity (n, %): not reported habitual wearers (n, %): not reported Lotrafilcon B (N = 42) women (n, %): 25 (60%) age (mean, SD): 19.8 ± 1.7 years race/ethnicity (n, %): not reported habitual wearers (n, %): not reported Balafilcon A (N = 64) women (n, %): 35 (55%) age (mean, SD): 21.0 ± 3.7 years race/ethnicity (n, %): not reported habitual wearers (n, %): not reported Comfilcon A (N = 43) women (n, %): 25 (58%) age (mean, SD): 19.5 ± 1.3 years race/ethnicity (n, %): not reported habitual wearers (n, %): not reported Etafilcon A (N = 52) women (n, %): 26 (50%) age (mean, SD): 20.6 ± 3.6 years race/ethnicity (n, %): not reported habitual wearers (n, %): not reported Overall (N = 314) women (n, %): 180 (57%) age (mean, SD): 20.7 ± 3.4 years race/ethnicity (n, %): not reported habitual wearers (n, %): not reported
Interventions	Senofilcon A material: silicone hydrogel replacement frequency: 7 days/6 nights Lotrafilcon A material: silicone hydrogel replacement frequency: 7 days/6 nights Lotrafilcon B material: silicone hydrogel replacement frequency: 7 days/6 nights Balafilcon A material: silicone hydrogel replacement frequency: 7 days/6 nights Comfilcon A material: silicone hydrogel replacement frequency: 7 days/6 nights Etafilcon A material: hydrogel replacement frequency: 7 days/6 nights
Outcomes	Primary outcome: conjunctival redness, superior palpebral changes incidence of corneal infiltrative events incidence of adverse events Secondary outcomes: not specified Adverse outcomes (Y/N), if yes, please describe: Y, "significant" events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. "Non‐significant" events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear. Measurement time points: baseline and 52 weeks; trial registration Version 1 assessments planned for baseline, 24 hours, 1 week, 1 month, 3 months, 6 months, 1 year Notes: incidence was calculated as the number of events divided by the total number of participants assigned to that lens type. High rates of lost to follow‐up across intervention groups; numbers of non‐neophytes were lower than required per protocol.
Notes	Sponsorship source: Johnson & Johnson Vision Care Author's name: Kathy Osborn, OD, MS, FAAO, FBCLA Institution: Vistakon Conflicts of interest: not reported Publication language: English Trial register:NCT00762788; other study ID: CR‐4472