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February 2005


24 Month Update of A Multicenter Trial of Silicone Hydrogel Soft Contact Lenses

Joseph Barr (The Ohio State University), Peter Bergenske (Pacific University), Peter Donshik (University of Connecticut Health Center), Glenda Secor (Private Practitioner), John Yoakum (Groat Eyecare Associates), Sally Dillehay (CIBA Vision Corporation), Bill Long (CIBA Vision Corporation)


PURPOSE: To report findings through 24 months of a 36 month trial of signs of corneal health, subjective symptoms and safety with continuous wear of NIGHT&DAY (N&D) lenses and low DK daily wear (DW) 2-week replacement soft contact lenses.

METHODS: 317 patients were dispensed to wear N&D for up to 30N CW and 81 neophyte patients were dispensed in a lens for DW. Clinical and subjective data were collected at follow-up visits for each group.

RESULTS: A cohort of 240 N&D and 58 DW patients completed all visits through 24 months. 30N CW was recommended for all N&D patients by the 24 month visit. For the N&D cohort, improvements in biomicroscopy grades were most dramatic within 1 week for limbal (p<0.001) and conjunctival (p<0.001) redness with 5 of 10 signs improving and 5 unchanged through 24 months. For the DW cohort, 4 of 10 signs worsened and 6 unchanged through 24 months. For subjective symptoms, end of day dryness improved in both frequency (p<0.001) and severity (p<0.001) among 11% of patients in N&D, while 11% more patients in the DW group reported more frequent (p=0.014) and severe (p=0.014) end of day dryness. The percentage of eyes achieving 20/20 VA in the N&D cohort improved from 78% at dispensing to 86% at 12 months (p=0.995) and 86% at 24 months (p=0.011). For DW, 87%, 64% and 66% of eyes had 20/20 VA or better at dispensing, 12 (p=0.001), and 24 (p=0.001) months, respectively. Discontinuations totaled 24% for N&D and 27% for DW, with 1 discontinuation in each group from a potential adverse event. Microbial keratitis did not occur in either group.

CONCLUSIONS: N&D worn for 30N CW performed very well for biomicroscopy signs while DW results were mixed. In the N&D group, 5 signs of corneal health improved and none declined. In the DW group no signs improved and 4 signs declined. VA improved in the N&D group and declined in the DW group. N&D also showed improvement in end of day dryness symptoms. Through 24 months, N&D worn for 30N CW may be healthier than DW lenses based on signs of corneal health, improvement in end of day dryness, and VA.

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