Clinical performance of daily disposable soft contact lenses using sustained release technology
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文摘

ass=""h4"">Purpose

Polyvinyl alcohol (PVA) is a successful tear film stabiliser and is widely used in comfort drops and some soft contact lens materials. A PVA-containing lens, nelfilcon A has been modified to include additional (non-functional) PVA in order to provide improved comfort. This study aims to examine the clinical performance of this nelfilcon A lens with AquaRelease™ (AquaRelease).

ass=""h4"">Methods

Two contralateral, investigator masked, open label, subjective and objective evaluations were conducted. The first examined the effect of adding increased molecular weight PVA to nelfilcon A (n = 5), and the second compared this AquaRelease lens to ocufilcon B (n = 34). The principal measures were non-invasive break-up time (NIBUT) and subjective comfort, which were assessed at the beginning and end of a week of daily wear, and three times throughout 1 day at 8, 12 and 16 h.

ass=""h4"">Results

All subjects successfully completed the daily wearing schedule of 16&#xa0;h. On initial insertion, subjective comfort and NIBUT improved for AquaRelease than original nelfilcon A lenses (p&#xa0;<&#xa0;0.05). Initial comfort was better for AquaRelease compared to ocufilcon B lenses (p&#xa0;=&#xa0;0.01); however, NIBUT was not statistically different (11.7&#xa0;±&#xa0;15.6&#xa0;s versus 8.4&#xa0;±&#xa0;6.8&#xa0;s; p&#xa0;=&#xa0;0.26). Subjective comfort decreased with time (p&#xa0;<&#xa0;0.001), but there was no significant difference between AquaRelease and ocufilcon B lenses (p&#xa0;=&#xa0;0.16). NIBUT was not significantly affected by time (p&#xa0;=&#xa0;0.56) or between lenses (p&#xa0;=&#xa0;0.33). At the end of a weeks’ wear, subjective initial, end-of-day, overall comfort and vision were rated significantly better with AquaRelease than ocufilcon B (p&#xa0;<&#xa0;0.01).

ass=""h4"">Conclusions

Release of additional non-functionalised PVA from the nelfilcon A lenses appears to enhance comfortable contact lens wear.

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