A three-month comparative daily-wear study of two high-water-content soft lenses

Abstract

Proclear ™ (Omafilcon A) is a novel biomimetic, 59% water content hydrogel lens. The material is termed “biomimetic” because it incorporates synthetic phosphorylcholine (PC), which is the predominant headgroup found on the outer surface of human cell membranes. PC has been shown to be the primary cell component responsible for human cell compatibility. The purpose of the study was to further investigate an earlier finding that Proclear lenses were more comfortable than Acuvue lenses. This was a 100-subject, 3-month, daily-wear study undertaken to assess the comparative clinical performance of Proclear (Biocompatibles) and Acuvue (Vistakon) lenses. The study was conducted at 10 optometric sites in the United States. Before the study, all of the subjects were successful Acuvue wearers. Subjects wore a Proclear lens in one eye and an Acuvue lens in the other eye. The Acuvue lenses were worn on a 14-day replacement schedule, whereas Proclear lenses were only replaced as necessary. The Proclear lenses achieved higher mean comfort scores at each of the follow-up visits, and this difference was significant ( p = 0.03). More subjects expressed a preference for the Proclear lens at all visits, and this number was statistically significant at the 1-week, 1-month, and 3-month visits ( p < 0.01). The reasons for lens preference tended to be because of comfort. Significant differences were noted in lens fit at all visits. More Proclear lenses showed minimal decentration, postblink movement, and optimal overall fit than did the Acuvue lenses. Significantly greater dehydration was noted with the Acuvue lens compared with Proclear ( p < 0.001). The study confirmed that the Proclear lenses were preferred to the Acuvue lenses. Preference was primarily based on subjective comfort.