Adverse Reactions (Problems And What To Do); Clinical Studies - Bausch & Lomb PuerVision2 Quick Start Manual

WHo sHould knoW tHat you
are Wearing ContaCt lenses:
• I nform your doctor (health care professional) about
being a contact lens wearer.
• A lways inform your employer of being a contact
lens wearer. Some jobs may require the use of eye
protection equipment or may require that you not
wear lenses.
Ask your eye care professional whether there are
any other wearing restrictions that apply to you. Write
those restrictions in the spaces provided below and
follow them carefully:
_______________________________________
_______________________________________
_______________________________________
_______________________________________
adVerse reaCtions
(Problems and
WHat to do)
you sHould be aWare tHat tHe
folloWing Problems may oCCur:
• E yes stinging, burning, itching (irritation), or other
eye pain
• C omfort is less than when lens was first placed on
eye
• A bnormal feeling of something in the eye (foreign
body, scratched area)
• E xcessive watering (tearing) of the eyes
• U nusual eye secretions
• R edness of the eyes
• R educed sharpness of vision (poor visual acuity)
• B lurred vision, rainbows, or halos around objects
• S ensitivity to light (photophobia)
• D ry eyes
if you notiCe any of tHe
aboVe, you sHould:
• Immediately remove your lenses.
• I f the discomfort or problem stops, then look
closely at the lens. If the lens is in any way damaged,
do not put the lens back on your eye. Place the
lens in the storage case and contact your eye care
professional. If the lens has dirt, an eyelash, or other
foreign body on it, or the problem stops and the
lens appears undamaged, you should thoroughly
clean, rinse, and disinfect the lenses; then reinsert
them. After reinsertion, if the problem continues,
you should immediately remove the lenses and
consult your eye care professional.
When any of the above problems occur, a
serious condition such as infection, corneal ulcer,
neovascularization, or iritis may be present. You should
keep the lens off your eye and seek immediate
professional identification of the problem and prompt
treatment to avoid serious eye damage.

CliniCal studies

The following clinical results are provided for
informational purposes. It is important to note that
the results below are from studies conducted with
the Bausch + Lomb PureVision
Visibility Tinted Contact Lens which has the same
lens material, but different lens design. These studies
were conducted with subjects not requiring astigmatic
correction.
Pre-aPProVal eXtended Wear study
study desCriPtion
A 12-month clinical study of the Bausch + Lomb
PureVision (balafilcon A) Visibility Tinted Contact
Lenses showed the lens is safe and effective for vision
correction for up to 30 days of continuous wear.
A total of 820 subjects were enrolled in the clinical
study. Six hundred ten (610) subjects completed the
one-year study. Subjects were fitted with a PureVision
Contact Lens on one eye and a Control lens the
other eye. Subjects were instructed to replace the
PureVision Contact Lens with a new lens every 30
days, and to wear the Control lens overnight for up to
six consecutive nights per week. Eyes had one night
without lens wear after the scheduled removal. The
Control lens was to be replaced with a new lens every
14 days.
study results
All predetermined safety and efficacy study endpoints
were successfully achieved. The study showed the
PureVision Contact Lenses, when worn on a 30-day
continuous wear basis, is equivalent in safety and
efficacy to the Control lens when worn on a 7-day
continuous wear basis.
safety
There were no reports of permanent loss of vision
for either the PureVision Contact Lenses or the
Control lenses. Of the subjects that entered into the
continuous wear phase of the study, 2. 9 % developed
corneal infiltrates of the severity identified in the study
protocol as a study safety endpoint in the eye with the
PureVision lens, compared to 1.3% in the control
®
eyes. It should be noted that the PureVision Contact
Lens and Control lenses were each fit on only the
right or left eye for each subject. Rates per subject are
expected to be higher when lenses are fit on both eyes.
Other reported adverse events included corneal
scars, keratitis, conjunctivitis, ocular infections, and
inflammatory reactions. Subjects reported other less
serious problems such as dryness, discomfort, and
burning and stinging. These symptoms were reported
at equivalent rates for the PureVision Contact Lens
and the Control lens.
effeCtiVeness
Not all of the subjects were able to wear their lens
for the maximum 30-day period. In this U.S. clinical
study subjects were required to maintain a minimum
wearing time in order to continue in the study. Some
subjects were discontinued from the study because
they were not able to wear the PureVision Contact
5
(balafilcon A)
®