NCT01354223.

Study characteristics
Methods	Study design: RCT, parallel‐group design Numbers randomized (total and per group): total 90 participants; 60 in Stenfilcon A group, 30 in Ocufilcon B Unit of randomization: person (1 eye per person) Masking: open‐label Exclusions and losses to follow‐up (total and per group): total 4 participants; 3 in Stenfilcon A, 1 in Ocufilcon B Number analyzed (total and per group): total 86 participants; 57 in Stenfilcon A, 29 in Ocufilcon B Unit of analysis (individual or eye): person Study duration (planned and actual): 3 months Intervention duration: 3 months How were missing data handled: not reported Sample size and power calculation: not reported
Participants	Country: USA Setting: 4 centers Inclusion criteria: at least 18 years of age; good general health; adapted current full‐time silicone hydrogel or soft contact lens wearer (at least 8 hours per day, worn daily for at least 1 month); requires spectacle lens powers between −1.00 and −6.00 DS; no more than 1.00 D of refractive astigmatism; willing to wear contact lenses in both eyes; manifest refraction Snellen VA equal to or better than 20/25 in each eye; contact lens correction to Snellen VA equal to or better than 20/30 in each eye Exclusion criteria: monovision modality; unwilling to be fit with distance lenses in both eyes; poor personal hygiene; active participation in another clinical trial within 30 days prior to this study; pregnant lactating or is planning a pregnancy within the next 3 months; a member, relative, or household member of the investigator or of the investigational office staff; sensitivity to study lubricants; previous refractive surgery; history of orthokeratology treatment; aphakic or pseudophakic; ocular diseases (glaucoma, uveitis, iritis, keratoconus); systemic diseases (diabetes, Sjögren's syndrome, lupus erythematosus); use of topical ocular medications or any medication that might interfere with contact lens wear or that would require the lenses to be removed during the day; clinically significant (grade 3 or 4) anterior segment abnormalities; history of corneal hypoesthesia, corneal ulcer, corneal infiltrates or fungal infections, papillary conjunctivitis. Slit lamp findings that would contraindicate contact lens wear (dry eye, punctate staining over grade 2, corneal scars, neovascularization, seborrheic conjunctivitis, seborrheic eczema, blepharitis) Baseline characteristics Refractive condition: myopia Stenfilcon A (N = 60) women (n, %): 38 (63%) age (mean, SD, range): 32.6 ± 8.88 years race/ethnicity (n, %): not reported habitual wearers (n, %): 60 (100%) Ocufilcon B (N = 30) women (n, %): 21 (70%) age (mean, SD, range): 29.8 ± 8.55 years race/ethnicity (n, %): not reported habitual wearers (n, %): 30 (100%) Overall (N = 90) women (n, %): 59 (66%) age (mean, SD, range): 31.7 ± 8.82 years race/ethnicity (n, %): not reported habitual wearers (n, %): 90 (100%) Notes: baseline characteristics were comparable
Interventions	Stenfilcon A material: silicone hydrogel replacement frequency: daily Ocufilcon B material: hydrogel replacement frequency: daily
Outcomes	Primary outcomes: incidence of biomicroscopy number of adverse events in unique eyes Snellen VA of 20/25 or better Secondary outcomes: percentage of unique eyes that were reported to have no symptoms of discomfort average hours of daily wearing time Adverse outcomes (Y/N), if yes, please describe: Y, serious and non‐serious adverse events (papillary conjunctivitis: 6 events in 3 participants (5.00%) in Stenfilcon A group) Measurement time points: baseline, weeks 1, 2, months 1, 2, and 3
Notes	Sponsorship source: CooperVision Inc. Authors' names: Stephen Byrnes, Lee Rigel, Mary Jo Stiegemeier, Peter Van Hoven, Eric White Institution: Eric M. White, OD, Inc Conflicts of interest : not reported Publication language: English Trial register:NCT01354223

CCLRU: Cornea and Contact Lens Research Unit
CL: contact lens(es)
D: diopters
DS: diopters sphere
logMAR: Logarithm of the Minimum Angle of Resolution
NEI: National Eye Institute
OSDI: Ocular Surface Disease Index
RCT: randomized controlled trial
SCL: soft contact lens(es)
SD: standard deviation
TBUT: tear breakup time
VAS: visual analog scale
VA: visual acuity