Diec 2012.

Study characteristics
Methods	Study design: RCT, parallel‐group design, 3 arms Numbers randomized (total and per group): total 126 participants enrolled, 120 were dispensed lenses, 40 in each group Unit of randomization: person Masking: not masked, "open‐label" Exclusions and losses to follow‐up (total and per group): 6 participants failed to meet the exclusion criteria overall, and there were no dropouts Number analyzed (total and per group): total 120 (40 in each group) Unit of analysis (person 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: "A sample size of 40 participants for each lens type was required to have 80% power to detect a statistically significant difference of 0.5 ± 0.7 units in the 0 to 4 grading scale and a 10 ± 15 units in the subjective ratings between the lens types."
Participants	Country: Australia Setting: Brien Holden Vision Institute Inclusion criteria: age 18 years and up, willing to comply with contact lens schedule, normal ocular health, vision correctable to at least 6/12 (20/40) or better in each eye, may be experienced or inexperienced with contact lenses Exclusion criteria: pre‐existing injury, irritation, or conditions of the cornea, conjunctiva, or eyelids precluding wearing of contact lenses; systemic diseases that impact eye health (diabetes, Graves disease, autoimmune disorders); use of ocular medications (category S3 and above) within 12 weeks prior to trial; use of systemic or topical medications that may alter eye health; eye surgery within 12 weeks prior to trial; previous corneal refractive surgery; allergy to topical anesthesia; pregnant; currently enrolled in another trial; previously participated in a clinical trial within 2 weeks (or 48 hours for "short term" trials) prior to this trial Baseline characteristics Refractive condition: myopia Etafilcon A (N = 40) women (n, %): 22 (55%) age (mean, SD): 29.0 ± 10.7 years race/ethnicity (n, %): not reported habitual wearers (n, %): 32 to 34 (80% to 85%) Narafilcon A (N = 40) women (n, %): 22 (55%) age (mean, SD): 29.9 ± 12.0 years race/ethnicity (n, %): not reported habitual wearers (n, %): 32 to 34 (80% to 85%) Senofilcon A (N = 40) women (n, %): 22 (55%) age (mean, SD): 31.0 ± 13.8 years race/ethnicity (n, %): not reported habitual wearers (n, %): 32 to 34 (80% to 85%) Overall (N = 120) women (n, %): 66 (55%) age (mean, SD): 29.97 ± 12.16 years (calculated) race/ethnicity (n, %): not reported habitual wearers (n, %): 16 to 22 (13% to 18%)
Interventions	Etafilcon A material: hydrogel replacement frequency: daily Narafilcon A material: silicone hydrogel replacement frequency: daily Senofilcon A material: silicone hydrogel replacement frequency: daily Notes: participants were instructed to wear a minimum of 6 days per week and 8 hours per day
Outcomes	Primary outcome: corneal and conjunctival staining (CCLRU 0‐to‐4 grading scale in 0.1 increments; 0 = none, 4 = severe) Secondary outcomes: bulbar, limbal, and palpebral redness, indentation (CCLRU 0 to 4 grading scale) contact lens variables such as lens fit hours of average and comfortable wear time subjective variables of comfort overall, on insertion, during day, end of day, and dryness at the end of day (1‐to‐100 scale; 1 = extremely uncomfortable and 100 = extremely comfortable) subjective symptoms including blurred vision, dryness, discomfort, and lens awareness for subsequent lens wearing visits (5 options; none = I do not have this symptom, trace = I seldom notice this symptom, mild = I sometimes notice this symptom, moderate = I frequently notice this symptom, and severe = I always notice this symptom) Adverse outcomes (Y/N), if yes, please describe: Y, serious and non‐serious adverse events Measurement time points: baseline, 2 weeks, 1 month, and 3 months
Notes	Sponsorship source: Alcon Labs and Brien Holden Vision Institute Author's name: Jennie Diec Institution: Brien Holden Vision Institute Conflicts of interest : not reported Publication language: English Trial register: ACTRN12609000812291