Effect of Masking on Subjective Responses to Daily Disposable Contact Lenses.

PURPOSE: To explore the effect of masking on subjective responses when wearing daily disposable (DD) contact lenses. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Comfort-enhanced daily disposable contact lens reduces symptoms among weekly/monthly wear patients.

OBJECTIVES: The primary objective of this trial was to explore the extent to which common contact lens-related symptoms may be improved among symptomatic daily wear contact lens wearers who habitually replaced their lenses at intervals of 1 to 4 weeks when fitted with DAILIES AquaComfort Plus for daily disposable, daily wear. Primary variables were frequency and severity of tired eyes, irritated eyes, lens awareness, blurred vision, redness, discomfort, deposits, and dryness. METHODS: Eight sites, investigators enrolled 83 subjects who reported two or more of the symptoms with frequency of often or always. A sample size estimate required 60 subjects for 80% power, two-sided alpha = 0.05. Subjects were dispensed for 4 weeks of bilateral lens wear. Follow-up visits were at 2 and 4 weeks; data were collected by telephone surveys at 1 and 3 weeks. RESULTS: Eighty-one subjects completed the trial. Statistically significant improvements in symptom frequency were found for the symptoms of tired eyes (P<0.001), irritated eyes (P<0.001), blurred vision (P<0.001), redness (P<0.001), discomfort (P=0.024), deposits/lens needs cleaning (P<0.001), and dryness (P<0.001). Statistically significant improvements in symptom severity were found for tired eyes (P<0.001), irritated eyes (P<0.001), blurred vision (P<0.001), redness (P<0.001), discomfort (P=0.037), deposits/lens needs cleaning (P<0.001), and dryness (P<0.001). Biomicroscopy signs of limbal redness, bulbar redness, and conjunctival staining showed statistically significant improvements at 2 weeks (P=0.02, 0.01, and 0.035) and 4 weeks (P< or =0.001, 0.012, and 0.008). CONCLUSIONS: A range of common symptoms can be reduced and biomicroscopy signs can be improved with a comfort-enhanced daily disposable, daily wear lens, thus providing benefits that patients can experience and eye care practitioners can appreciate.