PACKAGE INSERT / FITTING GUIDE
CAUTION: Federal law restricts this device to
sale by or on the order of a licensed practitioner.
© Bausch & Lomb Incorporated. All rights reserved worldwide.
®/TM are trademarks of Bausch & Lomb Incorporated or its affiliates.
Other product/brand names are trademarks of their respective owners.
Name and Address of Manufacturer:
Bausch & Lomb Incorporated
Rochester, New York, USA 14609
Printed in the U.S.A.
SL7385-1
8067601
SYMBOL REFERENCE GUIDE
For labels and cartons:
Quality System Certification Symbol
Fee Paid for Waste Management
Sterile Using Steam or Dry Heat
See Instruction Leaflet
Diameter
Use by Date (Expiration Date)
Batch Code
Authorized Representative in European Community
Caution: Federal law restricts this device to sale by or
on the order of a licensed practitioner
Diopter (Lens Power)
Base Curve
Storage Temperature
TABLE OF CONTENTS
Important 2
Description 3
Lens Parameters Available 4
How the Lens Works (Actions) 4
Indications 4
Contraindications (Reasons Not To Use) 6
Warnings 7
Precautions 9
Adverse Reactions 13
Clinical Studies 15
Selection of Patients 21
Fitting Procedure 21
Pre-Fitting Examination 21
Initial Lens Power Selection 22
Initial Lens Evaluation 22
Criteria of a Well-Fitted Lens 22
Characteristics of a Tight (Steep) Lens 22
Characteristics of a Loose (Flat) Lens 23
Follow-up Care 23
Practitioner Fitting Sets 24
Wearing Schedule 24
Monovision Fitting Guidelines 25
Patient Selection 25
Eye Selection 26
Special Fitting Considerations 26
Near Add Determination 27
Trial Lens Fitting 27
Adaptation 27
Other Suggestions 28
Handling of Lens 29
Patient Lens Care Directions 29
Frequent/Planned Replacement Wear 29
Disposable Wear 29
Therapeutic Wear 29
Care for a Sticking (Nonmoving) Lens 29
Reporting of Adverse Reactions 30
How Supplied 30
CAUTION
Federal (U.S.A.) law restricts this device to sale by or on the order of a licensed
practitioner.
IMPORTANT
This package insert and fitting guide has been developed to provide practitioners
with information covering characteristics of the Bausch + Lomb PureVision®2
(balafilcon A) Visibility Tinted Contact Lens and to illustrate fitting procedures. It
is effective as of November 2013 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.
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DESCRIPTION
The Bausch + Lomb PureVision® 2 (balafilcon A) Visibility Tinted Contact Lens is a
soft hydrophilic contact lens which is available as a spherical lens. 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
The Bausch + Lomb PureVision®2 (balafilcon A) Visibility Tinted Contact
Lenses, with AerGel™ technology lens material, are manufactured by the
FormCast™ manufacturing process, cast molding process, and are surface
treated by the Performa™ surface treatment process which transforms
hydrophobic silicone to hydrophilic silicate.
The Bausch + Lomb PureVision®2 (balafilcon A) Visibility Tinted Contact Lens
may be prescribed for Frequent/Planned Replacement or Disposable Wear.
–11
[cm3O2(STP) x cm]/(sec x cm2 x mmHg)
@ 35° C Polarographic Method
(Boundary and Edge Corrected)
–11
101 x 10
[cm3O2(STP) x cm]/(sec x cm2 x
mmHg) @ 35°C Polarographic Method
(Boundary Corrected, Non-Edge Corrected)
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LENS PARAMETERS AVAILABLE
The Bausch + Lomb PureVision®2 (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: 8.6mm
Powers (Spherical): +6.00D to -12.00D*
*
Additional powers may be introduced over time, check periodically for product availability.
HOW THE LENS WORKS (ACTIONS)
In its hydrated state, the Bausch + Lomb PureVision®2 (balafilcon A) Visibility
Tinted Contact Lens when placed on the cornea acts as a refracting medium to
focus light rays on the retina. When placed on the cornea for therapeutic use,
the Bausch + Lomb PureVision®2 (balafilcon A) Visibility Tinted Contact Lens
acts as a bandage to protect the cornea and relieve pain during treatment of
ocular pathologies.
INDICATIONS
Vision Correction
The Bausch + Lomb PureVision®2 (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 and hyperopia) in aphakic and/or not-aphakic persons
with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, 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 +8.00D to -20.00D 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.
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Therapeutic Use
The Bausch + Lomb PureVision
is also indicated for therapeutic use. Use as a bandage contact lens for corneal
protection and corneal pain relief during treatment of ocular pathologies as well
as post-surgical conditions. Applications of the Bausch + Lomb PureVision®2
(balafilcon A) Visibility Tinted Contact Lens include but are not limited to
conditions such as the following:
• For corneal protection in conditions such as entropion, trichiasis, tarsal
scars, recurrent corneal erosion and post surgical ptosis for corneal
protection;
• For corneal pain relief in conditions such as bullous keratopathy, epithelial
erosion and abrasion, filamentary keratitis, post-keratoplasty;
• For use as a bandage during the healing process of conditions such
as chronic epithelial defects, corneal ulcer, neurotrophic keratitis,
neuroparalytic keratitis, chemical burns, and post surgical epithelial
defects.
• For post-surgical conditions that include bandage use such as LASIK, PRK,
PK, PTK, lamellar grafts, corneal flaps, and additional corneal surgical
conditions.
Bausch + Lomb PureVision®2 (balafilcon A) Visibility Tinted Contact Lenses for
therapeutic use can also provide optical correction during healing if required.
Frequent/Planned Replacement Wear
When prescribed for Frequent/Planned Replacement Wear, the Bausch
+ Lomb PureVision
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
(balafilcon A) Visibility Tinted Contact Lens is to be discarded after each
removal.
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2 (balafilcon A) Visibility Tinted Contact Lens
®
2 (balafilcon A) Visibility Tinted Contact Lens is to be
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2
CONTRAINDICATIONS
(REASONS NOT TO USE)
DO NOT USE the Bausch + Lomb PureVision®2 (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®2 (balafilcon A) Visibility
Tinted Contact Lens
• Any active corneal infection (bacterial, fungal, or viral)
• If eyes become red or irritated
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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.
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.
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 microcycsts 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 long term 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, practitioners’ 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.
• 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.
PRECAUTIONS
Special 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 the extremes of the power range, above
+3.00D and –5.00D.1 In the U.S. clinical study, the rate of infiltrative keratitis was
found to be higher with higher lens powers (see Clinical Studies section of this
package insert).
• The potential impact of these factors on the patient’s ocular health should be
carefully weighed against the patient’s need for refractive correction; therefore,
the prescribing eye care professional should carefully monitor the continuing
ocular health of the patient and lens performance on eye.
• 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.
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.
• 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 Bausch + Lomb PureVision
(balafilcon A) Visibility Tinted Contact Lenses until the determination is made
that the eye has healed completely.
In Addition, For Therapeutic Use
• Close professional supervision is necessary for therapeutic use of
Bausch + Lomb PureVision®2 (balafilcon A) Visibility Tinted Contact Lenses.
• Medications necessary for treatment should be used with caution under close
supervision by the eye care professional.
Eye care professionals should carefully instruct patients about the following lens
care and safety precautions. For therapeutic use, in some circumstances only
the eye care professional will insert and remove lenses and if so, patients should
be instructed NOT to handle lenses themselves. It is strongly recommended
that patients be provided with a copy of the Bausch + Lomb PureVision®2
(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.
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2
• Always handle lenses carefully and avoid dropping them.
• Do not touch the lens with fingernails.
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• Carefully follow the handling, insertion, removal, cleaning, disinfecting, storing
and wearing instructions in the Patient Information Booklet for the Bausch +
Lomb® PureVision®2 (balafilcon A) Visibility Tinted Contact Lens 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.
• For THERAPEUTIC USE, in some circumstances only the eye care
professional will insert and remove lenses and if so, patients should be instructed
NOT to handle lenses themselves.
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®2 (balafilcon A) Visibility
Tinted Contact Lens because the lens dimensions will be altered.
Eye injury due to irritation or infection may result from lens contamination. To reduce
the risk of contamination, review the appropriate manufacturer’s labeled lens care
instructions with the patient.
• 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.
8
• 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 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.
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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, the patient should look closely at the lens. If
the lens is in any way damaged, do not put the lens back on the eye. The patient
should 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.
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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.
During THERAPEUTIC USE, an adverse eect may be due to the original
disease or injury or may be due to the eects of wearing a contact lens. There
is a possibility that the existing disease or condition might become worse when
a soft contact lens for therapeutic use is used to treat an already diseased or
damaged eye. The patient should be instructed to avoid serious eye damage by
contacting the eye care professional IMMEDIATELY if there is any increase in
symptoms while wearing the lens.
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12
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CLINICAL STUDIES
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 Contact Lens which has the same lens material, but different lens design.
EXTENDED WEAR STUDY
STUDY DESCRIPTION
Study Design
The objective of this 12-month study was to evaluate the safety and efficacy of the
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
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
Endpoint n % n %
Slit Lamp
Findings ≥
138 17.5% 139 17.6 % 1.0 -0.1% 2.6% 10.0%
Grade 2
Corneal
Infiltrates ≥
23 2.9% 10 1.3% 2.3 1.6% 2.9% 5.0%
Grade 2
Visual
Acuity Worse
0 0.0% 2 0.3% 0.0 -0.3% 0 .1% 5.0 %
than 20/40
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contact lenses and Control lenses were
Relative
Risk/
PureVision
Control
Difference
in %
Upper
95%
Confidence
Level
Clinically
Significant
Difference
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 ( ≥ Grade2 )
1,2
Any Finding
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
Epithelial Microcysts 1.0% 1.0%
Corneal Neovascularization 1.0% 1.7%
Other Anterior Segment Abnormalities
External Adnexa Abnormalities 2.7% 2.7%
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.
1
Epithelial Edema 1.3% 1.4%
Ungraded Slit Lamp Findings
Conjunctivitis 2.4% 2.0%
Corneal Striae 0.0% 0.3%
3
17.5% 17. 6%
2.9% 1.3%
13.2% 13.8%
It should be noted that the Bausch + Lomb 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.
Lens Power
PureVision
Control
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.
Plano to – 3.00 1.7 %
– 3.25 to – 6.00 3.2 %
> – 6.00 6.4 %
Total 2.9 %
Lens Power
Plano to – 3.00 0.9 %
– 3.25 to – 6.00 1.5 %
> – 6.00 1.3 %
Total 1.3 %
Corneal Infiltrates
(≥ Grade 2)
Corneal Infiltrates
(≥ Grade 2)
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 %)
18171615
*
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.
Efficacy Outcomes
The contact lens visual acuity was measured at each scheduled and unscheduled
follow-up visit throughout the one-year study. For the 610 subjects that completed
the study, visual acuity of 20/20 or better was reported for 87% and 86% of the
measurements for the PureVision® contact lens and Control lens, respectively.
Similarly, visual acuity of 20/25 or better was reported 98% and 97% of the times
for the PureVision® contact lens and Control lens.
Wearing Time
In this U.S. clinical study subjects were required to maintain a minimum wearing
time in order to continue in the study. For the subjects that completed the study, the
average continuous wear time for the PureVision® contact lens was at least 28.0
days per month, from the 2-month visit through the 12-month visit. At these visits the
same subjects reported they were able to wear the PureVision® contact lens at least
22 days continuously 94% of the times they were asked.
During the course of the study, 15 subjects were discontinued from the study
because they were not able to wear the PureVision® contact lens for 30 days.
Twenty-one (21) subjects were discontinued from the study because they were not
able to wear the Control lens for 7 days.
Overnight Corneal Swelling
Two separate studies assessed the corneal swelling response induced by overnight
contact lens wear. In the first study, 30 subjects each wore either a +3.00D, –3.00D,
or –9.00D PureVision® contact lens and an equivalent power lens made from a
conventional hydrogel material (Control lens) on the contralateral eye overnight
under closed eye conditions for approximately eight hours. The corneal swelling,
measured as the percent increase in the center thickness of the cornea, with the
Control lens (9.1%) was significantly greater than that measured in conjunction with
the PureVision® contact lenses (4.1%). In the second study, the corneal swelling
response was measured under similar conditions. In this study the response to a
–3.00D PureVision® contact lens (3.0%) was compared to the swelling response to
no lens wear (1.9%). The responses were not statistically different (p-value > 0.05).
THERAPEUTIC USE STUDIES
Introduction
Two prospective open-ended non-randomized clinical trials were conducted to
evaluate PureVision
applications. The studies, conducted in Asia, included subjects who presented at
the two centers requiring continuous lens wear for relief of corneal pain, a bandage
during the healing process of certain corneal conditions and corneal protection.
®
contact lenses as continuous wear lenses for therapeutic
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STUDY # 1
Study Description
A total of 54 eyes of 54 patients were reported with a mean wearing time of 1.1
months (range from 1 day to 11 months). Twenty-eight (52%) of the subjects were
male and 26 (48%) were female with an average age 50 years (range from 4 to
79 years old).
Thirty-six of the fifty-four subjects (67%) were post surgical cases including
post-surgical treatment after refractive laser assisted in-situ keratomieusis (LASIK),
photorefractive keratectomy (PRK), phototherapeutic keratoplasty (PTK), and
penetrating keratoplasty (PK), corneal grafts, conjunctival flaps, vitrectomy, tumor
excision of the conjunctiva, anterior stromal puncture, and phacoemulsification leak
repair. A total of 7 cases for bullous keratopathy, 3 cases of chemical burn, 3 cases
of epithelial abrasion or recurrent erosion, 3 cases of corneal perforation, 1 case
neurotrophic ulcer, and 1 case corneal laceration were also treated.
Data Analysis and Results:
Where corneal pain relief was one of the treatment goals, twenty-seven of the
28 (96%) cases were considered successful with complete or considerable pain
relief and an additional patient reported partial pain relief (4%). Of the forty cases
where the lens was used as a bandage during corneal healing was one of the goals,
total success was achieved in 83% (33/40) of the cases and partial success was
achieved in 96% (38/40) of the cases. All twenty one cases (100%) of the subjects
needing corneal protection were effective.
STUDY # 2
Study Description
A total of 30 eyes of 28 subjects were fitted with the PureVision
a mean wear time of 25.2 days (ranging from 3 days to 3 months). Nineteen (68%)
of the subjects were male and 9 (32%) were female with an age range from 9 years
to 55 years.
Lens wearing categories included post-surgical bandage use in 27 cases (postPK, post-deep lamellar keratoplasty, pterygium excision, conjunctival allograft,
peripheral ulcerative keratitis, descemetocoele, post-chemical burns, and corneal
perforation from severe dry eye), mechanical support use for 1 case of bullous
keratopathy, symptomatic corneal pain relief for 1 case of filamentary keratitis and
healing adjunct in 1 case of a non-healing corneal abrasion.
Data Analysis and Results:
Therapeutic success was reported in 83% of the eyes where the lens was used as a
post-surgical bandage, and 100% in each case of mechanical support (3), epithelial
abnormalities (1), bullous keratopathy (1), and filamentary keratitis (1). Fifteen of 19
eyes (79%) with post-surgical epithelial defects were successful within 3 days to 3
weeks. All subjects reported symptomatic relief. Complications included infectious
keratitis in 2 subjects that were being treated for post-PK persistent epithelial defect
®
contact lens with
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and corneal vascularization observed in one case where the cornea was already
compromised due to a grade 4 alkali injury. The investigators reported the overall
study therapeutic success in 87% (26/30) of the eyes.
SELECTION OF PATIENTS
The eye care professional should not fit patients who cannot or will not adhere to a
recommended care or replacement regimen, or are unable to place and remove
the lenses should not be provided with them. Failure to follow handling and cleaning
instructions could lead to serious eye infections which might result in corneal ulcers.
Patient communication is vital because it relates not only to patient selection but also
to ensure compliance. It is also necessary to discuss the information contained in the
Patient Information Booklet with the patient at the time of the initial examination.
Patients selected to wear Bausch + Lomb PureVision®2 (balafilcon A) Visibility
Tinted Contact Lenses should be chosen for their motivation to wear contact
lenses, general health and cooperation. The eye care professional must take care
in selecting, examining and instructing contact lens patients. Patient hygiene and
willingness to follow practitioner instructions are essential to their success.
A detailed history is crucial to determining patient needs and expectations.
Your patient should be questioned regarding vocation, desired lens wearing time
(full or part time), and desired lens usage (reading, recreation or hobbies).
Initial evaluation of the trial lens should be preceded by a complete eye examination,
including visual acuity with and without correction at both distance and near,
keratometry and slit lamp examination.
It is normal for the patient to experience mild symptoms such as lens awareness,
variable vision, occasional tearing (watery eyes) and slight redness during the
adaptation period. Although the adaptation period varies for each individual,
generally within one week these symptoms will disappear.
If these symptoms persist, the patient should be instructed to contact his or her eye
care professional.
FITTING PROCEDURE
1. Pre-Fitting Examination
A pre-fitting patient history and examination are necessary to:
• Determine whether a patient is a suitable candidate for contact lenses (consider
patient hygiene and mental and physical state),
• Make ocular measurements for initial contact lens parameter selection, and
• Collect and record baseline clinical information to which post-fitting
examination results can be compared.
A pre-fitting examination should include spherocylinder refraction and VA,
keratometry, and biomicroscopic examination.
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2. Initial Lens Power Selection
• Lens power is determined from the patient’s spherical equivalent prescription
corrected to the corneal plane. Select the appropriate lens and place on the
eye.
• Allow the lens to remain on the eye long enough (10 to 20 minutes) to achieve a
state of equilibrium. Small variations in the tonicity, pH of the lens solutions, and
individual tear composition may cause slight changes in fitting characteristics.
• Allow any increase in tear flow to subside before evaluating the lens. The time
required will vary with the individual.
3. Initial Lens Evaluation
a. To determine proper lens parameters, observe the lens relationship to the eye
using a slit lamp.
• Movement: The lens should provide discernible movement with:
— Primary gaze blink
— Upgaze blink
— Upgaze lag
• Centration: The lens should provide full corneal coverage.
b. Lens evaluation allows the contact lens fitter to evaluate the lens/cornea
relationship in the same manner as would be done with any soft lens. If after
the lens has settled on the eye, the patient reports lens sensation, or if the
lens is moving or decentering excessively, the lens should not be dispensed.
Alternatively, if the patient reports variable vision, or if the lens shows insufficient
movement, the lens should not be dispensed.
4. Criteria of a Well-Fitted Lens
If the initial lens selection fully covers the cornea, provides discernible movement
after a blink, is comfortable for the patient and provides satisfactory visual
performance, it is a well fitted lens and can be dispensed.
5. Characteristics of a Tight (Steep) Lens
A lens which is much too steep may subjectively and objectively cause distortion
which will vary after a blink. However, if a lens is only marginally steep, the initial
subjective and objective vision and comfort findings may be quite good. A
marginally steep lens may be differentiated from a properly fitted lens by having
the patient gaze upward. A properly fitted lens will tend to slide downward
approximately 0.5mm while a steep lens will remain relatively stable in relationship
to the cornea, particularly with the blink.
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6. Characteristics of a Loose (Flat) Lens
If the lens is too flat, it will:
• Decenter, especially on post-blink.
• Have a tendency to edge lift inferiorly and sit on the lower lid, rather than
positioning between the sclera and palpebral conjunctiva.
• Have a tendency to be uncomfortable and irritating with fluctuating vision.
• Have a tendency to drop or lag greater than 2.0mm on upgaze post-blink.
7. Follow-up Care
a. Follow-up examinations are necessary to ensure continued successful contact
lens wear. From the day of dispensing, the following schedule is a suggested
guideline for follow up.
• 24 hours
• 10 days
• 1 month
• 3 months
• Every six months thereafter
At the initial follow-up evaluations the eye care professional should again
reassure the patient that any of the previously described adaptive symptoms are
normal, and that the adaptation period should be relatively brief. Depending on
the patient’s prior experience with contact lenses and/or continuous wear, the
eye care professional may consider prescribing a one week period of daily wear
adaptation prior to beginning continuous wear.
b. Prior to a follow-up examination, the contact lenses should be worn for at least
4 continuous hours and the patient should be asked to identify any problems
which might be occurring related to contact lens wear. If the patient is wearing
the lenses for continuous wear, the follow-up examination should be conducted
as early as possible the morning after overnight wear.
c. With lenses in place on the eyes, evaluate fitting performance to assure that
CRITERIA OF A WELL FITTED LENS continue to be satisfied. Examine the
lenses closely for surface deposition and/or damage.
d. After the lens removal, instill sodium fluorescein [unless contraindicated] into
the eyes and conduct a thorough biomicroscopy examination.
1. The presence of vertical corneal striae in the posterior central cornea and/
or corneal neovascularization may be indicative of excessive
corneal edema.
2. The presence of corneal staining and/or limbal-conjunctival hyperemia
can be indicative of an unclean lens, a reaction to solution preservatives,
excessive lens wear, and/or a poorly fitting lens.
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3. Papillary conjunctival changes may be indicative of an unclean and/or
damaged lens.
If any of the above observations are judged abnormal, various professional
judgments are necessary to alleviate the problem and restore the eye to
optimal conditions. If the CRITERIA OF A WELL FITTED LENS are not
satisfied during any follow-up examination, the patient should be re-fitted with a
more appropriate lens.
PRACTITIONER FITTING SETS
Lenses must be discarded after a single use and must not be used from patient to
patient.
WEARING SCHEDULE
The wearing and replacement schedules should be determined by the eye care
professional. Regular checkups, as determined by the eye care professional, are
extremely important.
Daily Wear
There may be a tendency for the daily wear patient to over wear the lenses initially.
Therefore, the importance of adhering to a proper, initial daily wearing schedule
should be stressed to these patients. The wearing schedule should be determined by
the eye care professional. The wearing schedule chosen by the eye care professional
should be provided to the patient.
Continuous Wear (Greater than 24 hours or While Asleep):
The wearing schedule should be determined by the prescribing eye care
professional for each individual patient, based upon a full examination and patient
history as well as the practitioner’s experience and professional judgment. Bausch
+ Lomb recommends beginning continuous wear patients with the recommended
initial daily wear schedule, followed by a period of daily wear, and then gradual
introduction of continuous wear one night at a time, unless individual considerations
indicate otherwise. The professional should examine the patient in the early stages
of continuous wear to determine the corneal response. The lens must be removed,
cleaned and disinfected or disposed of and replaced with a new lens, as determined
by the prescribing eye care professional. (See the factors discussed in the Warnings
section.)
Once removed, a lens should remain out of the eye for a period of rest
overnight or longer, as determined by the prescribing eye care professional.
Disposable Lens Wear
No lens care is needed. The lenses are discarded every time they are removed from
the eye. Lenses should only be cleaned, rinsed and disinfected on an emergency
basis when replacement lenses are not available.
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Frequent/Planned Replacement
When removed between replacement periods, lenses must be cleaned and
disinfected before reinsertion, or be discarded and replaced with a new lens.
Therapeutic Lens Wear
Close professional supervision is necessary and strongly recommended.
Bausch + Lomb
worn on a continuous wear basis for up to 30 nights and days or for shorter periods
as directed by the eye care professional. The eye care professional should provide
specific instructions regarding lens care, removal, and insertion. In some cases, only
the eye care professional should handle the lens insertion and removal.
MONOVISION FITTING GUIDELINES
1. Patient Selection
a. Monovision Needs Assessment
Occupational and environmental visual demands should be considered.
Monovision contact lens wear may not be optimal for such activities as:
b. Patient Education
PureVision®2 (balafilcon A) Visibility Tinted Contact Lenses can be
For a good prognosis the patient should have adequately corrected distance
and near visual acuity in each eye. The amblyopic patient or the patient with
significant astigmatism (greater than one [1] diopter) in one eye may not be
a good candidate for monovision with the Bausch + Lomb PureVision®2
(balafilcon A) Visibility Tinted Contact Lenses.
If the patient requires critical vision (visual acuity and stereopsis) it should
be determined by trial whether this patient can function adequately with
monovision.
1. Visually demanding situations such as operating potentially dangerous
machinery or performing other potentially hazardous activities; and
2. Driving automobiles (e.g., driving at night). Patients who cannot pass their
state drivers license requirements with monovision correction should be
advised to not drive with this correction, OR may require that additional
over-correction be prescribed.
All patients do not function equally well with monovision correction. Patients
may not perform as well for certain tasks with this correction as they have with
bifocal reading glasses. Each patient should understand that monovision can
create a vision compromise that may reduce visual acuity and depth perception
for distance and near tasks. During the fitting process it is necessary for the
patient to realize the disadvantages as well as the advantages of clear near
vision in straight ahead and upward gaze that monovision contact lenses
provide.
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2. Eye Selection
Generally, the non-dominant eye is corrected for near vision. The following test for
eye dominance can be used.
a. Ocular Preference Determination Methods
• Method 1—Determine which eye is the “sighting dominant eye.” Have
the patient point to an object at the far end of the room. Cover one eye. If
the patient is still pointing directly at the object, the eye being used is the
dominant (sighting) eye.
• Method 2—Determine which eye will accept the added power with the
least reduction in vision. Place a trial spectacle near add lens in front of one
eye and then the other while the distance refractive error correction is in
place for both eyes. Determine whether the patient functions best with the
near add lens over the right or left eye.
b. Refractive Error Method
For anisometropic corrections, it is generally best to fit the more hyperopic (less
myopic) eye for distance and the more myopic (less hyperopic) eye for near.
c. Visual Demands Method
Consider the patient’s occupation during the eye selection process to
determine the critical vision requirements. If a patient’s gaze for near tasks is
usually in one direction correct the eye on that side for near.
Example:
A secretary who places copy to the left side of the desk will usually function best
with the near lens on the left eye.
3. Special Fitting Considerations
Unilateral Lens Correction
There are circumstances where only one contact lens is required. As an example,
an emmetropic patient would only require a near lens while a bilateral myope may
require only a distance lens.
Example:
A presbyopic emmetropic patient who requires a +1.75 diopter add would have a
+1.75 lens on the near eye and the other eye left without a lens.
A presbyopic patient requiring a +1.50 diopter add who is –2.50 diopters myopic
in the right eye and –1.50 diopters myopic in the left eye may have the right eye
corrected for distance and the left uncorrected for near.
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4. Near Add Determination
Always prescribe the lens power for the near eye that provides optimal near acuity
at the midpoint of the patient’s habitual reading distance. However, when more than
one power provides optimal reading performance, prescribe the least plus (most
minus) of the powers.
5. Trial Lens Fitting
A trial fitting is performed in the office to allow the patient to experience monovision
correction. Lenses are fit according to the directions in the general fitting guidelines.
Case history and standard clinical evaluation procedure should be used to
determine the prognosis. Determine which eye is to be corrected for distance and
which eye is to be corrected for near. Next determine the near add.
With trial lenses of the proper power in place observe the reaction to this mode of
correction.
Immediately after the correct power lenses are in place, walk across the room and
have the patient look at you. Assess the patient’s reaction to distance vision under
these circumstances. Then have the patient look at familiar near objects such as a
watch face or fingernails. Again assess the reaction. As the patient continues to look
around the room at both near and distant objects, observe the reactions. Only after
these vision tasks are completed should the patient be asked to read print. Evaluate
the patient’s reaction to large print (e.g. typewritten copy) at first and then graduate
to newsprint and finally smaller type sizes.
After the patient’s performance under the above conditions are completed, tests
of visual acuity and reading ability under conditions of moderately dim illumination
should be attempted.
An initial unfavorable response in the office, while indicative of a guarded prognosis,
should not immediately rule out a more extensive trial under the usual conditions in
which a patient functions.
6. Adaptation
Visually demanding situations should be avoided during the initial wearing period. A
patient may at first experience some mild blurred vision, dizziness, headaches, and
a feeling of slight imbalance. You should explain the adaptational symptoms to the
patient. These symptoms may last for a brief minute or for several weeks. The longer
these symptoms persist, the poorer the prognosis for successful adaptation.
To help in the adaptation process the patient can be advised to first use the lenses in
a comfortable familiar environment such as in the home.
Some patients feel that automobile driving performance may not be optimal during
the adaptation process. This is particularly true when driving at night. Before driving
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a motor vehicle, it may be recommended that the patient be a passenger first to
make sure that their vision is satisfactory for operating an automobile. During the first
several weeks of wear (when adaptation is occurring), it may be advisable for the
patient to only drive during optimal driving conditions. After adaptation and success
with these activities, the patient should be able to drive under other conditions with
caution.
7. Other Suggestions
The success of the monovision technique may be further improved by having your
patient follow the suggestions below.
• Having a third contact lens (distance power) to use when critical distance
viewing is needed.
• Having a third contact lens (near power) to use when critical near viewing
is needed.
• Having supplemental spectacles to wear over the monovision contact lenses
for specific visual tasks may improve the success of monovision correction. This
is particularly applicable for those patients who cannot meet state licensing
requirements with a monovision correction.
• Make use of proper illumination when carrying out visual tasks. Success in fitting
monovision can be improved by the following suggestions.
• Reverse the distance and near eyes if a patient is having trouble adapting.
• Refine the lens powers if there is trouble with adaptation. Accurate lens power is
critical for presbyopic patients.
• Emphasize the benefits of the clear near vision in straight ahead and upward
gaze with monovision.
• The decision to fit a patient with a monovision correction is most
appropriately left to the eye care professional in conjunction with the
patient after carefully considering the patient’s needs.
• All patients should be supplied with a copy of the Bausch + Lomb
PureVision®2 (balafilcon A) Visibility Tinted Contact Lens Patient
Information Booklet.
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HANDLING OF LENS
Patient Lens Care Directions
When lenses are dispensed, the patient should be provided with appropriate and
adequate instructions and warnings for lens care handling. The eye care professional
should recommend appropriate and adequate procedures and products for each
individual patient in accordance with the particular lens wearing schedule and care
system selected by the professional, the specific instructions for such products and
the particular characteristics of the patient.
Frequent / Planned Replacement Wear: For complete information
concerning the care, cleaning and disinfection of contact lenses refer to the
Bausch + Lomb PureVision®2 (balafilcon A) Visibility Tinted Contact Lens Patient
Information Booklet.
Disposable Wear: For complete information concerning emergency lens
care, refer to the Bausch + Lomb PureVision®2 (balafilcon A) Visibility Tinted
Contact Lens Patient Information Booklet.
Therapeutic Wear: For complete information concerning emergency lens care,
refer to the Bausch + Lomb PureVision®2 (balafilcon A) Visibility Tinted Contact
Lens Patient Information Booklet or your eye care professional.
CARE FOR A STICKING
(NONMOVING) LENS
If the lens sticks (stops moving), the patient should be instructed to use a lubricating
or rewetting solution in their eye. The patient should be instructed to not use plain
water, or anything other than the recommended solutions. The patient should be
instructed to contact the eye care professional if the lens does not begin to move
upon blinking after several applications of the solution, and to not attempt to remove
the lens except on the advice of the eye care professional.
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REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in patients wearing
Bausch + Lomb PureVision®2 (balafilcon A) Visibility Tinted Contact Lenses or
experienced with the lenses should be reported to:
Bausch & Lomb Incorporated
Rochester, New York 14609
Toll Free Telephone Number
In the Continental U.S., Alaska, Hawaii
1-800-553-5340
In Canada
1-888-459-5000 (Option 1 - English, Option 2 - French)
HOW SUPPLIED
Each sterile lens is supplied in a plastic blister package containing borate buffered
saline solution. The container is marked with the manufacturing lot number of the
lens, the base curve, sphere, diameter and expiration date.
Store lenses at room temperature (60°F to 80°F / 15°C to 25°C).
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