Bausch & Lomb PureVision Toric Contact Lenses - Manual (Page 2)

IMPORTANT
This package insert and fitting guide has been developed to provide practitioners with
information covering characteristics of the Bausch & Lomb® PureVision® Toric (balafilcon A)
Visibility Tinted Contact Lens with the Lo-Torque® design and to illustrate fitting procedures. It is
effective as of September 2009 and supersedes all prior fitting guides for the product described.
Please read carefully and keep this information for future use.
This package insert and fitting guide is intended for the eye care professional, but should be
made available to patients upon request. The eye care professional should provide the patient
with the patient instructions that pertain to the patient’s prescribed lens and the recommended
wearing schedule.
DESCRIPTION
The Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is a soft
hydrophilic contact lens which is available as a flexible shell with a toric surface. The lens
material, balafilcon A, is a copolymer of a silicone vinyl carbamate, N-vinyl-pyrrolidone, a
siloxane crosslinker and a vinyl alanine wetting monomer, and is 36% water by weight when
immersed in a sterile borate buffered saline solution. This lens is tinted blue with up to 300 ppm
of Reactive Blue Dye 246.
The physical/optical properties of the lens are:
Specific Gravity:
1.064
Refractive Index: 1.426
Light Transmittance: C.I.E. value—at least 95%
Water Content: 36%
Oxygen Permeability: 91 x 10 –11 [cm 3 O 2 (STP) x cm]/(sec x cm 2 x
mmHg) @ 35° C Polarographic Method
(Boundary and Edge Corrected)
101 x 10 –11 [cm 3 O 2 (STP) x cm]/(sec x cm 2 x
mmHg) @ 35°C Polarographic Method
(Boundary Corrected, Non-Edge Corrected)
The Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lenses, with AerGel™
technology lens material, are manufactured by a cast molding process and are surface treated by
the Performa™ surface treatment process which transforms hydrophobic silicone to hydrophilic
silicate. The anterior surface of the lens contains the aspheric optic zone, prism ballast
and comfort chamfer feature of the Bausch & Lomb PureVision Toric (balafilcon A) Visibility
Tinted Contact Lens. The posterior surface is manufactured with a spherocylindrical curve to
accommodate the required astigmatic power.
Prism ballasting stabilizing geometry—increased
thickness from apex to base of lens offers excellent
axis stabilization
Refined aspheric optic zone—anterior and posterior
optic zone diameters are adjusted to minimize
variations in thickness providing optimal stability
360° comfort chamfer—reduces lens mass for
rotational stability
Balanced vertical thickness profile—uniform
mid-peripheral thickness at apex, center, and base
of optic zone enhances rotational stability
Unique bicurve posterior design for optimum
centration and visual acuity
Rounded edges—provide comfort plus optimal
movement over conjunctival tissue
Guide Mark System
Each Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is marked with
3 Guide Marks in the lens perimeter, 30 degrees apart at 5, 6, and 7 o’clock. These Guide Marks
give an instant reference for estimating lens rotation and orientation. They are, in effect, a
protractor guide on the lens surface. All guide markings make proper axis orientation and fitting
faster and easier. The center guide mark need not position at 6 o’clock on the cornea.
Guide Markings
30˚ 60˚
(6 o’clock)
Center Guide
Diameter
14.0mm
LENS PARAMETERS AVAILABLE*
The Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is a hemispherical
shell of the following dimensions:
Diameter:
14.0mm
Center Thickness: 0.05mm to 0.50mm
Base Curve: 8.7mm
Sphere Powers: –0.25D to –6.00D in 0.25D steps
Cylinder Powers: –0.75D, –1.25D and –1.75D
Axis: 10° to 180° in 10° Increments
Lens Prism: Prism is located at the base of the lens to stabilize lens positioning when
lens is on the eye.
Comfort Chamfer: A wedge-shaped tapered section on the anterior surface of the lens in
the periphery of the lens from the 3 to 9 o’clock areas. This reduces lens
thickness.
*Additional powers may be introduced over time, check for product availability.
HOW THE LENS WORKS (ACTIONS)
In its hydrated state, the Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact
Lens has a unique Lo-Torque® design that results in excellent stability and when placed on the
cornea, acts as a refracting medium to focus light rays on the retina.
INDICATIONS
The Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is indicated for
daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection
or disposal of the lens, as recommended by the eye care professional. The lens is indicated for
the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/
or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters,
that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned
Replacement Wear or Disposable Wear in spherical powers ranging from +6.00D to -9.00D when
prescribed for up to 30 days of extended wear and from +20.00D to –20.00D for daily wear or
extended wear up to 7 days.
NOTE: See the WARNINGS reference to the relationship between lens wearing schedule and
corneal complications.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the Bausch & Lomb PureVision Toric
(balafilcon A) Visibility Tinted Contact Lens is to be cleaned, rinsed and disinfected each time it is
removed from the patient’s eye and discarded after the recommended wearing period prescribed
by the eye care professional. The lens may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the Bausch & Lomb PureVision Toric (balafilcon A) Visibility
Tinted Contact Lens is to be discarded after each removal.
CONTRAINDICATIONS (REASONS NOT TO USE)
DO NOT USE the Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens when
any of the following conditions exist:
• Acute and subacute inflammation or infection of the anterior chamber of the eye
• Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids
• Severe insufficiency of lacrimal secretion (dry eyes)
• Corneal hypoesthesia (reduced corneal sensitivity)
• Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses
• Allergic reactions of ocular surfaces or adnexa (surrounding tissue) that may be induced or
exaggerated by wearing contact lenses or use of contact lens solutions
• Allergy to any ingredient, such as mercury or Thimerosal, in a solution which is to be used to
care for the Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens
• Any active corneal infection (bacterial, fungal, or viral)
• If eyes become red or irritated
WARNINGS
After a thorough eye examination, including appropriate medical background, patients should be
fully apprised by the prescribing professional of all the risks with contact lens wear.
Patients should be advised of the following warnings pertaining to contact lens wear:
• Problems with contact lenses and lens care products could result in
serious injury to the eye. It is essential that patients follow their eye
care professional’s direction and all labeling instructions for proper use
of lenses and lens care products, including the lens case. Eye problems,
including corneal ulcers, can develop rapidly and lead to loss of vision.
• When prescribed for Frequent/Planned Replacement Wear, the need for
strict compliance with the care regimen including cleaning of the lens
case, wearing restrictions, wearing schedule, and follow-up visit schedule
should be emphasized to the patient.
• Studies have shown that contact lens wearers who are smokers have a
higher incidence of adverse reactions than nonsmokers.
• If a patient experiences eye discomfort, excessive tearing, vision changes,
or redness of the eye, the patient should be instructed to immediately
remove lenses and promptly contact his or her eye care professional.
EXTENDED WEAR
• The risk of microbial keratitis has been shown to be greater among users of extended wear
contact lenses than among users of daily wear contact lenses. The risk among extended wear
lens users increases with the number of consecutive days that the lenses are worn between
removals, beginning with the first overnight use.
Some researchers believe that these complications are caused by one or more of the
following: a weakening of the cornea’s resistance to infections, particularly during a closed-
eye condition, as a result of hypoxia; an eye environment which is somewhat more conducive
to the growth of bacteria and other microorganisms, particularly when a regular periodic
lens removal and disinfecting or disposal schedule has not been adhered to by the patient;
improper lens disinfection or cleaning by the patient; contamination of lens care products;
poor personal hygiene by the patient; patient unsuitability to the particular lens or wearing
schedule; accumulation of lens deposits; damage to the lens; improper fitting; length of
wearing time; and the presence of ocular debris or environmental contaminants.
While the great majority of patients successfully wear contact lenses, extended wear of lenses
also is reported to be associated with a higher incidence and degree of epithelial microcysts
and infiltrates, and endothelial polymegathism, which require consideration of discontinuation
or restriction of extended wear. The epithelial conditions are reversible upon discontinuation
of extended wear.
The risk of microbial keratitis has not been determined for this lens. Post marketing studies
are in progress.
The reversibility of endothelial effects of contact lens wear has not been conclusively
established. As a result, professionals views of extended wearing times vary from not
prescribing extended wear at all to prescribing flexible wearing times from occasional
overnight wear to prescribing extended wearing periods from 1 to 30 days with specified
intervals of no lens wear for certain patients, with follow-up visits, and with proper care
regimen.
PRECAUTIONS
Precautions for Eye Care Professionals
• Due to the small number of patients enrolled in clinical investigation of lenses, all refractive
powers, design configurations, or lens parameters available in the lens material are not
evaluated in significant numbers. Consequently, when selecting an appropriate lens design
and parameters, the eye care professional should consider all characteristics of the lens that
can affect lens performance and ocular health, including oxygen permeability, wettability,
central and peripheral thickness, and optic zone diameter.
The oxygen transmissibility is below the established threshold required to prevent overnight
corneal edema for portions of the power range, including plus powers and some low
minus power lenses. 1 In the U.S. clinical study of the PureVision (spherical) lens, the rate
of infiltrative keratitis was found to be higher with higher lens powers (see CLINICAL STUDY
section of the package insert).
• The potential impact of these factors on the patient’s ocular health should be care-fully
weighed against the patient’s need for refractive correction; therefore, the continuing ocular
health of the patient and lens performance on eye should be carefully monitored by the
prescribing eye care professional.
• Eye care professionals should instruct the patient to REMOVE A LENS IMMEDIATELY if an eye
becomes red or irritated.
• Fluorescein, a yellow dye, should not be used while the lenses are on the eyes. The lenses
absorb this dye and become discolored. Whenever fluorescein is used in eyes, the eyes should
be flushed with sterile saline solution that is recommended for in-eye use.
• The patient should be instructed to always discard disposable lenses and lenses worn on a
frequent/planned replacement schedule after the recommended wearing schedule prescribed
by the eye care professional.
• Some patients will not be able to tolerate continuous wear even if able to tolerate the same
or another lens on a daily wear basis. Some patients who are able to tolerate continuous wear
will not be able to wear their lenses continuously for 30 days. Patients should be carefully
evaluated for continuous wear prior to prescription and dispensing, and eye care professionals
should conduct early and frequent follow-up examination to determine ocular response to
continuous wear.
• As with any contact lens, follow-up visits are necessary to assure the continuing health of the
patient’s eyes. The patient should be instructed as to a recommended follow-up schedule.
• Aphakic patients should not be fitted with PureVision Contact Lenses until the determination is
made that the eye has healed completely.
Eye care professionals should carefully instruct patients about the following lens care and
safety precautions. It is strongly recommended that patients be provided with a copy of the
Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens Patient Information
Booklet available from Bausch & Lomb and understand its contents prior to dispensing the
lenses.
Handling Precautions
• Always wash and rinse hands before handling lenses. Do not get cosmetics, lotions, soaps,
creams, deodorants, or sprays in the eyes or on the lenses. It is best to put on lenses before
putting on makeup. Water-base cosmetics are less likely to damage lenses than oil-base
products.
• Be sure that before leaving the eye care professional’s office, the patient is able to remove
lenses promptly or have someone else available to remove them.
• Be certain that the fingers or hands are free of foreign materials before touching lenses, as
microscopic scratches of the lenses may occur, causing distorted vision and/or injury to the
eye.
• Always handle lenses carefully and avoid dropping them.
• Do not touch the lens with fingernails.
• Carefully follow the handling, insertion, removal, cleaning disinfecting, storing and
wearing instructions in the Patient Information Booklet for the Bausch & Lomb PureVision
Toric (balafilcon A) Visibility Tinted Contact Lenses and those prescribed by the eye care
professional.
• Never use tweezers or other tools to remove lenses from the lens container unless specifically
indicated for that use. Pour the lens into the hand.
Solution Precautions
Do not use the Allergan Ultracare Disinfecting System or any of its components (Ultracare
Disinfecting Solution, Ultracare Neutralizing Tablets, Lens Plus Daily Cleaner and Ultrazyme
Enzymatic Cleaner) to clean and disinfect the Bausch & Lomb PureVision Toric (balafilcon A)
Visibility Tinted Contact Lenses because the lens dimension will be altered.
• Always use
fresh unexpired lens care solutions.
• Always follow directions in the package inserts for the use of contact lens solutions.
• Sterile unpreserved solutions, when used, should be discarded after the time specified in the
labeling directions.
• Always keep the lenses completely immersed in the recommended storage solution when
lenses are not being worn (stored). Prolonged periods of drying will damage lenses. Follow
the lens care directions for Care for a Dried Out (Dehydrated) Lens in the patient information
booklet if lens surface does become dried out.
• Do not use saliva or anything other than the recommended solution for lubricating or wetting
lenses.
• Tap water, distilled water or homemade saline should not be used as a substitute for any
component in the lens care regimen since they have been associated with an Acanthamoeba
keratitis infection.
• Never use conventional hard contact lens solutions that are not also recommended for use
with prescribed lenses.
• Do not mix or alternate lens care systems or solutions unless indicated in the lens care system
labeling.
• Do not heat the chemical disinfection solution or lenses.
Lens Wearing Precautions
• Never wear lenses beyond the period recommended by the eye care professional.
• If the lens sticks (stops moving) on the eye, follow the recommended directions on Care for a
Sticking Lens. The lens should move freely on the eye for the continued health of the eye. If
nonmovement of the lens continues, the patient should be instructed to immediately consult
his or her eye care professional.
• Avoid, if possible, all harmful or irritating vapors and fumes while wearing lenses.
• If aerosol products are used while wearing lenses, exercise caution and keep eyes closed until
the spray has settled.
Lens Case Precautions
• Contact lens cases can be a source of bacterial growth. To prevent contamination and to
help avoid serious eye injury, always empty and rinse the lens case with fresh, sterile rinsing
solution and allow to air dry.
• Lens cases should be replaced at regular intervals as recommended by the lens case
manufacturer or eye care professional.
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 practitioner) 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 the 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 complications, 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 conditions, a patient presenting symptoms
of abrasions or early ulcers should be evaluated 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 Bausch & Lomb PureVision (balafilcon
A) Visibility Tinted Contact Lens which has the same lens material, but different lens design
(spherical). The study was conducted with subjects not requiring astigmatic 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 subjects 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) experienced by eyes in
the PureVision Contact Lens and Control lenses were calculated. 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 follows: 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 substantially
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:
PureVision Control Relative Risk
PureVision/
Control
Difference
in %
Upper 95%
Confidence
Level
Clinically
Significant
Difference
Endpoint n % n %
Slit Lamp
Findings ×
Grade 2
138 17.5% 139 17.6% 1.0 -0.1% 2.6% 10.0%
Corneal
Infiltrates ×
Grade 2
23 2.9% 10 1.3% 2.3 1.6% 2.9% 5.0%
Visual
Acuity Worse
than 20/40
0 0.0% 2 0.3% 0.0 -0.3% 0.1% 5.0%
Summary of Slit Lamp Findings
Slit lamp examinations were conducted at every study visit. Each graded slit lamp parameter was
scored on a qualitative grade scale ranging from 0 to 4, with Grade 0 representing the absence
of findings, and Grades 1 through 4 representing successively worse findings. For each study
eye, a determination was made for each parameter as to whether, or not a positive finding was
presented at any visit. The following table describes slit lamp findings × Grade 2 and ungraded
slit lamp findings.
PureVision Control
Graded Slit Lamp Findings ( × Grade 2)
Any Finding 1,2 17.5% 17.6%
Corneal Staining 8.2% 8.4%
Limbal Injection 3.7% 4.3%
Bulbar Injection 5.2% 4.7%
Tarsal Conjunctival Abnormalities 3.9% 3.9%
Corneal Infiltrates 1 2.9% 1.3%
Epithelial Edema 1.3% 1.4%
Epithelial Microcysts 1.0% 1.0%
Corneal Neovascularization 1.0% 1.7%
PureVision Control
Ungraded Slit Lamp Findings
Other Anterior Segment Abnormalities 3 13.2% 13.8%
External Adnexa Abnormalities 2.7% 2.7%
Conjunctivitis 2.4% 2.0%
Corneal Striae 0.0% 0.3%
1. Slit Lamp Finding and Corneal Infiltrates × Grade 2 were the safety endpoints for this study.
2. The total of all Graded slit lamp findings does not equal the category of Any Finding.
3. The more common findings identified as Other Anterior Segment Abnormalities included
conjunctival staining; dimple veils; mucin balls; lipid deposits; and ghost vessels.
It should be noted that the PureVision Contact Lens and the Control lens 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.
Corneal Infiltrates
The following table describes the rate of corneal infiltrates according to the lens power used.
PureVision
Lens Power
Corneal Infiltrates
( × Grade 2)
Plano to – 3.00 1.7 %
– 3.25 to – 6.00 3.2 %
> – 6.00 6.4 %
Total 2.9 %
Control
Lens Power
Corneal Infiltrates
( × Grade 2)
Plano to – 3.00 0.9 %
– 3.25 to – 6.00 1.5 %
> – 6.00 1.3 %
Total 1.3 %
Other Lens-Related Adverse Events
In addition to the outcomes described above, the following lens related adverse events were
noted. This table does not include conjunctivitis or tarsal conjunctival abnormalities, e.g., giant
papillary conjunctivitis.
Other Important Lens-Related Adverse Events
PureVision Control
Corneal Scar 14 (1.8 %) 5 (0.6 %)
Other Ocular Inflammation* 10 (1.3 %) 2 (0.3 %)
Anterior Chamber Reaction 2 (0.3 %) 1 (0.1 %)
Permanent Loss of Vision 0 (0.0 %) 0 (0.0 %)
* Other Ocular Inflammation includes episcleritis, scleritis, iritis/uveitis. This condition was
reported in association with other conditions such as keratitis, corneal infiltrates, blepharitis,
corneal abrasion, and contact lens over wear.
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.
1 2 3 4 5 6 7 8 9 10 11
1. Holden BA, Mertz GW. Critical Oxygen Levels to Avoid Corneal Edema for Daily and
Extended Wear Contact Lenses. Invest Ophthalmol Vis Sci 25:1162, 1984.