title: Effect of Masking on Subjective Responses to Daily Disposable Contact Lenses.
abstract: To explore the effect of masking on subjective responses when wearing daily disposable (DD) contact lenses.
  
  
  
  In an adaptation phase, habitual wearers of Manufacturer-A (MFA) (n = 43) and Manufacturer-B (MFB) (n = 53) wore MFA-brand 1 or MFB-brand 1 DDs, respectively, for 30 days, open-label. Subjects were then randomly assigned to one of two experiments. Each experiment included two, 3-day crossover phases. An enhanced version of MFA and MFB lenses (MFA-brand 2 and MFB-brand 2) were worn contralaterally to evaluate potential differences in masking result between manufacturers. Experiment 1: subjects were fully masked to lens and packaging (FM) then unmasked (UM). Experiment 2: subjects were FM then partially masked using an over-label (PM). Comfort ratings (0-100) were recorded for each lens daily and preference between lenses was recorded on day 3 for each crossover phase. The mean difference between 0-100 ratings or preference when FM or PM versus UM for the same lens was considered a measurement of the effect associated with masking. The purpose of the study was withheld from subjects to minimize bias.
  
  
  
  The effect associated with masking for habitual wearers of MFA and MFB lenses was less than 1 out of 100 (0 ± 2.5) in both experiments. Fifty-eight subjects (60%) expressed no preference when FM. This decreased to 29 (30%) when UM or PM (proportion test, p < 0.001). Approximately half the subjects had a change in lens preference when they were UM or PM, primarily in favor of their habitual lens manufacturer.
  
  
  
  Masking did not have a measurable impact on 0-100 ratings with the DD lenses used in this study but did have an impact on lens preference. Subjects were more likely to express a preference when they handled the lenses and were exposed to the lens packaging and, in some cases, able to read the lens brand and lens manufacturer.
authors.affiliation: *OD, PhD, FAAO †Dipl Ing. (AO), PhD, FAAO ‡PhD MCOptom, FAAO §OD, FAAO ∥MOptom, FAAO Centre for Contact Lens Research, School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario, Canada (NK, DL, CAW, DF); and Alcon Laboratories, Inc., Ft. Worth, Texas (PB, MF).
authors.forename: Nancy
authors.initials: N
authors.lastname: Keir
authors.forename: Doerte
authors.initials: D
authors.lastname: Luensmann
authors.forename: Craig A
authors.initials: CA
authors.lastname: Woods
authors.forename: Peter
authors.initials: P
authors.lastname: Bergenske
authors.forename: Mary
authors.initials: M
authors.lastname: Fahmy
authors.forename: Desmond
authors.initials: D
authors.lastname: Fonn
mesh_terms: D000221:Adaptation, Ocular; D000293:Adolescent; D000328:Adult; D003261:Contact Lenses; D003263:Contact Lenses, Hydrophilic / Q000706:statistics & numerical data*; D018592:Cross-Over Studies; D000068240:Data Anonymization; D004209:Disposable Equipment; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000070659:Patient Comfort; D057240:Patient Preference; D017060:Patient Satisfaction; D055815:Young Adult