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

Abstract

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).

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.

Results: All subjects successfully completed the daily wearing schedule of 16h. On initial insertion, subjective comfort and NIBUT improved for AquaRelease than original nelfilcon A lenses (p<0.05). Initial comfort was better for AquaRelease compared to ocufilcon B lenses (p=0.01); however, NIBUT was not statistically different (11.7+/-15.6s versus 8.4+/-6.8s; p=0.26). Subjective comfort decreased with time (p<0.001), but there was no significant difference between AquaRelease and ocufilcon B lenses (p=0.16). NIBUT was not significantly affected by time (p=0.56) or between lenses (p=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<0.01).

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