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The Silicone Hydrogels website is partially supported through an educational grant from CIBA VISION

June 2003


Results of French multicenter trial on Focus NIGHT & DAY

Dr. George (Nantes), Dr. Lejeune (Lyon), Dr. Malet (Brest), Dr. Pagot (Strasbourg), Dr. Peyre (Paris), Dr. Subirana (Toulouse)



Patients around the world who require vision correction have shown high interest in continuous wear contact lenses. Manufacturers have responded by developing innovative materials that meet the physiological and mechanical requirements for this demand. CIBA Vision Corporation launched the first high Dk fluorosilicone soft contact lens in Mexico in 1998 and has conducted several observational trials in clinical practice settings in many countries.

The purpose of this trial was to report results from clinical practices in France. Six practitioners in France enrolled 134 subjects in this 4 month, open-label, multi-center, prospective, randomized, cross-over trial. Subjects were randomized to be dispensed either Focus NIGHT & DAY [FND] (CIBA Vision Corporation, Duluth, GA, USA) or Acuvue [AV](Vistakon, Inc., Jacksonville, FL, USA) and then crossed-over to the alternative lens after either 3 months' experience with FND or 1 month's experience with AV. Clinical and subjective data were collected at scheduled follow-up visits.

After 1 month of wear, FND was rated better for all aspects of comfort and overall average symptoms than AV. Wearers were satisfied with both lenses and lens features were comparable through 1 month. Preference was higher for FND after crossing over either from or to AV. Eight-six percent of FND and 85% of AV wearers reported that they usually slept 7 nights per week in their lenses. Seventy-seven percent of FND and 21% of AV wearers reported 22 to 31 nights of continuous wear.

Both lenses gave similar performance for visual acuity. Biomicroscopy signs averaged below grade 1 (trace) with more signs for FND averaging lower than for AV. Biomicroscopy signs generally improved when subjects changed from AV to FND. Deposits remained below grade 1 and wetting was nearly perfect throughout the study. Over 90% of fits for both lenses were acceptable or optimal.

The high subjective satisfaction, good clinical performance and the high Dk characteristics of the FND lens provides practitioners an alternative to low Dk contact lenses. The FND lens delivered subjective and clinical peformance that makes it a strong addition to vision correction options for continuous wear.

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