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.
RCT Entities:
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.
Authors: Nery García-Porta; Laura Rico-Del-Viejo; Alba Martin-Gil; Gonzalo Carracedo; Jesus Pintor; José Manuel González-Méijome Journal: Biomed Res Int Date: 2016-08-31 Impact factor: 3.411