Bausch & Lomb PureVision Multi-Focal Contact Lenses - Manual (Page 4)

Topics to Discuss with the Patient:
• As with any contact lens, follow-up visits are necessary to assure the
continuing health of the eyes. The patient should be instructed as to a
recommended follow-up schedule.
• Patients should be advised about wearing lenses during sporting and water
related activities. Exposure to water while wearing contact lenses in activities
such as swimming, water skiing and hot tubs may increase the risk of ocular
infection including but not limited to Acanthamoeba keratitis.
• Always contact the eye care professional before using any medicine in
the eyes.
Who Should Know That the Patient is Wearing Contact Lenses:
• Patients should inform their doctor (health care professional) about being
a contact lens wearer.
• Patients should always inform their employer of being a contact lens
wearer. Some jobs may require the use of eye protection equipment or
may require that you do not wear lenses.
ADVERSE REACTIONS:
The patient should be informed that the following problems may occur:
• Eyes stinging, burning, itching (irritation), or other eye pain
• Comfort is less than when lens was first placed on eye
• Abnormal feeling of something in the eye (foreign body, scratched area)
• Excessive watering (tearing) of the eyes
• Unusual eye secretions
• Redness of the eyes
• Reduced sharpness of vision (poor visual acuity)
• Blurred vision, rainbows, or halos around objects
• Sensitivity to light (photophobia)
• Dry eyes
If the patient notices any of the above, he or she should be instructed to:
• Immediately remove the lenses.
• If 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 the eye. Place
the lens in the storage case and contact the 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, the patient should thoroughly
clean, rinse, and disinfect the lenses; then reinsert them. After
reinsertion, if the problem continues, the patient should immediately
remove the lenses and consult his or her eye care professional.
If the above symptoms continue after removal of the lens, or upon
reinsertion of a lens, or upon insertion of a new lens, the patient should
immediately remove the lenses and contact his or her eye care
professional or physician, who must determine the need for examination,
treatment or referral without delay. (See Important Treatment Information
for Adverse Reactions.) A serious condition such as infection, corneal
ulcer, corneal vascularization, or iritis may be present, and may progress
rapidly. Less serious reactions such as abrasions, epithelial staining or
bacterial conjunctivitis must be managed and treated carefully to avoid
more serious complications.
Important Treatment Information for Adverse Reactions
Sight-threatening ocular complications associated with contact lens wear can
develop rapidly, and therefore early recognition and treatment of problems are
critical. Infectious corneal ulceration is one of the most serious potential com-
plications, and may be ambiguous in its early stage. Signs and symptoms of
infectious corneal ulceration include discomfort, pain, inflammation, purulent
discharge, sensitivity to light, cells and flare and corneal infiltrates.
Initial symptoms of a minor abrasion and an early infected ulcer are sometimes
similar. Accordingly, such epithelial defect, if not treated properly, may develop
into an infected ulcer. In order to prevent serious progression of these condi-
tions, a patient presenting symptoms of abrasions or early ulcers should be evalu-
ated as a potential medical emergency, treated accordingly, and be referred to a
corneal specialist when appropriate. Standard therapy for corneal abrasions such
as eye patching or the use of steroids or steroid/antibiotic combinations may
exacerbate the condition. If the patient is wearing a contact lens on the affected
eye when examined, the lens should be removed immediately and the lens and
lens care products retained for analysis and culturing.
CLINICAL STUDY:
The following clinical results are provided for informational purposes. It is
important to note that the results below are from a study conducted with the
PureVision Contact Lens which has the same lens material, but different lens
design (spherical). The study was conducted with subjects not requiring pres-
byopic correction
STUDY DESCRIPTION
Study Design
The objective of this 12-month study was to evaluate the safety and efficacy of
the BAUSCH & LOMB® PureVision® (balafilcon A) Visibility Tinted Contact
Lenses worn on a 30-day continuous wear basis, compared to a conventional
Control lens worn on a 7-day continuous wear basis. A total of 1640 eyes (820
subjects) were enrolled into this study. Subjects were fitted with a PureVision
Contact Lens on one eye while the contralateral eye was fitted with a Control
lens. 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.
Six hundred ten (610) subjects completed the one-year study. Ten subjects
discontinued in the daily wear adaptation period, 182 subjects discontinued
during the extended wear phase and 18 subjects were not dispensed lenses.
Patient Assessments
Subjects were evaluated at follow-up visits scheduled after 24 hours,
10 days, 1 month, 3 months, 6 months, 9 months, and 12 months of
lens wear.
Demographics
Subject recruitment was open to adapted and unadapted contact lens wearers.
There were no restrictions as to the subject’s gender or occupation, but sub-
jects were required to be of legal age (typically 18 or 21) and have the legal
capacity to volunteer. The ages of the subjects ranged from 18 to 74 years of
age, with a mean age of 33.6, and included 574 females and 228 males, with
a ratio of 2.52 females to every male. For the PureVision Contact Lens the
power range used was –0.50D to –9.00D. For the Control lens the power range
was –0.50D to –8.50D.
The previous lens wearing experience of the subjects that participated in the
study was 5% no lens wear, 43% daily wear, and 51% continuous wear. The
refractive errors of the subjects ranged from –0.25D to –11.75D, and included
up to –2.00D of astigmatism.
SUMMARY OF DATA ANALYSES
Summary of Data Analyses
The key endpoints for this study were:
1. grade 2 and higher slit lamp findings (safety endpoint),
2. grade 2 and higher corneal infiltrates (safety endpoint), and
3. contact lens corrected visual acuity worse than 20/40 (efficacy endpoint).
For each key endpoint, the rates (incidents of endpoint/number of eyes) expe-
rienced by eyes in the PureVision Contact Lens and Control lenses were calcu-
lated. The difference in rates between the two lens types was determined and
a 95% confidence interval for the difference was calculated. For each key
endpoint a “clinically significant difference” in the rates was established
before the study started. These “clinically significant differences” were as fol-
lows: 10% for total slit lamp findings ≥ Grade 2, 5% for corneal infiltrates ≥
Grade 2, and 5% for the acuity endpoint. For example, if the true rates of
endpoint infiltrates in the subject population were 9.99% in the PureVision
Contact Lens and 5% in the Control lens, these rates would be considered sub-
stantially equivalent (difference <5%).
In order to be successful for a given endpoint, the upper 95% confidence limit
for the difference in the study rates had to be less than the pre-established
“clinically significant difference.” This means that we are 95% confident that
the true difference is within tolerance. The safety and efficacy goals were met
for all three key endpoints. Results are as follows:
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