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. |