PURPOSE: We conducted a 3-month, randomized, comparative cross-over study to evaluate the clinical performance of lenses manufactured from omafilcon A on subjects with signs and symptoms of dry eye. The subjects' own daily wear soft lenses were used as controls. METHODS:Seventy-six subjects with objective evidence of dry eye, as defined in the NEI/Industry Workshop Report 1995, were fit with either the omafilcon A lenses (Proclear) or new control lenses. Subjects wore the lenses for 6 weeks and then crossed over to bilateral wear of the other lenses for an additional 6 weeks. During each part of the study, we examined subjects at 1 week, 1 month, and 6 weeks. Signs and symptoms of dry eye were evaluated, and on-eye dehydration of the lens was assessed. RESULTS: When the subjects were wearing the omafilcon A lenses, there was a statistically significant improvement in a number of subjective parameters including comfort, dryness, frequency of eye irritation, and frequency of burning. We found significantly less on-eye dehydration of the lens and fluorescein corneal staining with the omafilcon A lenses. CONCLUSIONS: This study indicated that the daily wear of omafilcon A lenses provided better comfort, fewer symptoms, less on-eye dehydration, and less fluorescein corneal staining than other soft daily wear contact lenses in subjects with mild to moderate dry eye.
RCT Entities:
PURPOSE: We conducted a 3-month, randomized, comparative cross-over study to evaluate the clinical performance of lenses manufactured from omafilcon A on subjects with signs and symptoms of dry eye. The subjects' own daily wear soft lenses were used as controls. METHODS: Seventy-six subjects with objective evidence of dry eye, as defined in the NEI/Industry Workshop Report 1995, were fit with either the omafilcon A lenses (Proclear) or new control lenses. Subjects wore the lenses for 6 weeks and then crossed over to bilateral wear of the other lenses for an additional 6 weeks. During each part of the study, we examined subjects at 1 week, 1 month, and 6 weeks. Signs and symptoms of dry eye were evaluated, and on-eye dehydration of the lens was assessed. RESULTS: When the subjects were wearing the omafilcon A lenses, there was a statistically significant improvement in a number of subjective parameters including comfort, dryness, frequency of eye irritation, and frequency of burning. We found significantly less on-eye dehydration of the lens and fluorescein corneal staining with the omafilcon A lenses. CONCLUSIONS: This study indicated that the daily wear of omafilcon A lenses provided better comfort, fewer symptoms, less on-eye dehydration, and less fluorescein corneal staining than other soft daily wear contact lenses in subjects with mild to moderate dry eye.
Authors: Jonathan M Lawton; Mariam Habib; Bingkui Ma; Roger A Brooks; Serena M Best; Andrew L Lewis; Neil Rushton; William Bonfield Journal: J Mater Sci Mater Med Date: 2017-08-17 Impact factor: 3.896