PURPOSE: The purpose of this study was to assess the clinical performance of hydrogel contact lenses manufactured from a novel, biomimetic, 59% water content, hydrogel material (Omafilcon A) as compared with a representative range of control materials (Polymacon, Etafilcon A, Atlafilcon A, and Welcon CE). METHOD:Thirty subjects were enrolled in a 2-month, double-masked, randomized, comparative, daily wear study. Subjects wore two sets of lenses; each pair was worn for 1 month. In each part of the study, subjects wore a Proclear (Biocompatibles Ltd.) test lens (Omafilcon A) in one eye and a control lens in the other eye. In vivo lens dehydration was measured after 1 week of lens wear. Lenses were collected at the end of the study and subjected to in vitro spectrofluorimetric analysis to measure protein and lipid deposits. RESULTS: Omafilcon A showed significantly less lipid spoilation than all the controls and significantly less protein than the Etafilcon A and Atlafilcon A lenses. High levels of protein were found on the Group 4 lenses (Etafilcon A) and high levels of lipid were found on the Group 2 lenses (Weicon CE). The Omafilcon A lenses exhibited significantly less on-eye dehydration than the Etafilcon A lenses (P < 0.0001) and the Weicon CE lenses (P < 0.005). The majority of subjects expressed a preference for the Proclear lens, generally for reasons of comfort. Some minor differences in aspects of lens fit were noted between the test and control lenses, however, none of these were felt to be great enough to affect comfort. CONCLUSIONS: We hypothesize that the reduced spoliation seen with the Omafilcon A lens relates to the biomimetic nature of the material which incorporates phosphorylcholine.
RCT Entities:
PURPOSE: The purpose of this study was to assess the clinical performance of hydrogel contact lenses manufactured from a novel, biomimetic, 59% water content, hydrogel material (Omafilcon A) as compared with a representative range of control materials (Polymacon, Etafilcon A, Atlafilcon A, and Welcon CE). METHOD: Thirty subjects were enrolled in a 2-month, double-masked, randomized, comparative, daily wear study. Subjects wore two sets of lenses; each pair was worn for 1 month. In each part of the study, subjects wore a Proclear (Biocompatibles Ltd.) test lens (Omafilcon A) in one eye and a control lens in the other eye. In vivo lens dehydration was measured after 1 week of lens wear. Lenses were collected at the end of the study and subjected to in vitro spectrofluorimetric analysis to measure protein and lipid deposits. RESULTS:Omafilcon A showed significantly less lipid spoilation than all the controls and significantly less protein than the Etafilcon A and Atlafilcon A lenses. High levels of protein were found on the Group 4 lenses (Etafilcon A) and high levels of lipid were found on the Group 2 lenses (Weicon CE). The Omafilcon A lenses exhibited significantly less on-eye dehydration than the Etafilcon A lenses (P < 0.0001) and the Weicon CE lenses (P < 0.005). The majority of subjects expressed a preference for the Proclear lens, generally for reasons of comfort. Some minor differences in aspects of lens fit were noted between the test and control lenses, however, none of these were felt to be great enough to affect comfort. CONCLUSIONS: We hypothesize that the reduced spoliation seen with the Omafilcon A lens relates to the biomimetic nature of the material which incorporates phosphorylcholine.