Clinical performance of daily disposable soft contact lenses using sustained release technology.
OBJECTIVE
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.
Peterson
Rachael C
RC
Life and Health Sciences, Aston University, Aston Triangle, Birmingham, UK.
Wolffsohn
James S
JS
Nick
Joachim
J
Winterton
Lynn
L
Lally
John
J
D000328:Adult; D020099:Coated Materials, Biocompatible; D003262:Contact Lenses, Extended-Wear; D019781:Corneal Topography; D003692:Delayed-Action Preparations; D004209:Disposable Equipment; D015352:Dry Eye Syndromes / Q000473:pathology / Q000517:prevention & control*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D010865:Pilot Projects; D011142:Polyvinyl Alcohol / Q000494:pharmacology*; D011446:Prospective Studies
D020099:Coated Materials, Biocompatible; D003692:Delayed-Action Preparations; D011142:Polyvinyl Alcohol