Bausch & Lomb Soflens Daily Disposable Toric for Astigmatism Contact Lenses - Manual (Page 3)

TABLE OF CONTENTS PAgE
Introduction 2
Description 2
Lens Parameters Available 3
How the Lens Works (Actions) 3
Indications 3
Contraindications (Reasons Not To Use) 4
Warnings 4
Precautions 4
Adverse Reactions 6
Important Treatment Information for Adverse Reactions 7
Selection of Patients 7
Fitting Procedure 8
Pre-fitting Examination 8
Initial Lens Power Selection 8
Initial Lens Evaluation 8
Criteria of a Well-Fitted Lens 9
Characteristics of a Tight (Steep) Lens 9
Characteristics of a Loose (Flat) Lens 9
Follow-up Care 9
Professional Fitting Sets 10
Wearing Schedule 10
Monovision Fitting Guidelines 10
Patient Selection 10
Eye Selection 11
Special Fitting Considerations 11
Near Add Determination 12
Trial Lens Fitting 12
Adaptation 12
Other Suggestions 13
Handling of Lens 13
Care for a Sticking (Nonmoving) Lens 13
Emergencies 14
Reporting of Adverse Reactions 14
How Supplied 14
Symbol Reference Guide 15
INTRODUCTION
This package insert has been developed to provide eye care professionals with information
covering characteristics of the Bausch & Lomb® SofLens® daily disposable Toric (hilafilcon B)
Visibility Tinted Contact Lens and to illustrate fitting procedures. It is effective as of September
2008 and supersedes all prior fitting guides for the product described. Please read carefully and
keep this information for future use.
This package insert 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 SofLens daily disposable Toric (hilafilcon B) Visibility Tinted Contact Lens is a
soft hydrophilic contact lens which is available in a flexible shell with a toric surface. The lens is
made from the hilafilcon B material, a hydrophilic copolymer of 2-hydroxyethyl methacrylate and
N-vinyl pyrrolidone, and is 59% water by weight when immersed in a sterile saline solution. This
lens is tinted blue with Reactive Blue Dye 246.
The physical/optical properties of the lens are:
Specific Gravity: 1.119
Refractive Index: 1.4036
Light Transmittance C.I.E. Y value—approximately 95%
Water Content: 59%
Oxygen Permeability: 22 x 10 –11 [cm 3 O
2
(STP) x cm]/(sec x cm 2 x mmHg) @ 35° C
(Polarographic Method)
The Bausch & Lomb SofLens daily disposable Toric (hilafilcon B) Visibility Tinted Contact Lens is to
be prescribed for single-use disposable wear.
The Bausch & Lomb SofLens daily disposable Toric (hilafilcon B) Visibility Tinted Contact
Lenses are manufactured by a cast molding process. The anterior surface of the lens contains
the spherical power, prism ballast and 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
Guide Mark System
Each Bausch & Lomb SofLens daily disposable Toric (hilafilcon B) Visibility Tinted Contact Lens is
marked with a Guide Mark in the lens perimeter at 6 o’clock. This Guide Mark gives an instant
reference for estimating lens rotation and orientation. It is, in effect, a protractor guide on the
lens surface. The guide marking makes proper axis orientation and fitting faster and easier. The
guide marking need not position at exactly 6 o’clock on the cornea.
LENS PARAMETERS AVAILABLE
The Bausch & Lomb SofLens daily disposable Toric (hilafilcon B) Visibility Tinted Contact Lens is a
hemispherical shell of the following dimensions:
Diameter:
14.2mm
Center Thickness: 0.05mm to 0.75mm
Base Curve: 8.6mm
Powers (Spherical): plano to -6.00D in 0.25D steps
-6.50D to -9.00D in 0.50D steps
Cylinder Powers: -0.75D, -1.25D, and -1.75D
Axis: 0° to 180° in 10° Increments
HOW THE LENS WORKS (ACTIONS)
In its hydrated state, the Bausch & Lomb SofLens daily disposable Toric (hilafilcon B) Visibility
Tinted Contact Lens has a unique Lo-Torque™ design that results in excellent stability, visual
acuity and comfort. When placed on the cornea, the Bausch & Lomb SofLens daily disposable
Toric (hilafilcon B) V isibility Tinted Contact Lens acts as a refracting medium to focus light rays
on the retina.
INDICATIONS
The Bausch & Lomb SofLens daily disposable Toric (hilafilcon B) Visibility Tinted Contact Lens
is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and
astigmatism) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 5.00
diopters or less, that does not interfere with visual acuity. The lens may be prescribed in
spherical powers ranging from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each
removal.
CONTRAINDICATIONS (REASONS NOT TO USE):
DO NOT USE the Bausch & Lomb SofLens daily disposable Toric (hilafilcon B) 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
• 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 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. Eye problems, including corneal ulcers, can develop rapidly and lead
to loss of vision.
• Daily wear lenses are not indicated for overnight wear, and patients should be
instructed not to wear lenses while sleeping. Clinical studies have shown that the risk
of serious adverse reactions is increased when daily wear lenses are worn overnight.
• 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.
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 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 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 the 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.
• Aphakic patients should not be fitted with Bausch & Lomb SofLens daily disposable Toric
(hilafilcon B) Visibility Tinted Contact Lenses until the determination is made that the eye has
healed completely.
• The lenses are prescribed for disposable wear, and are to be disposed of once they are
removed from the patient’s eye. It is important that patients be instructed to always have
available a pair of replacement lenses. In the event that a lens must be removed from the
eye because of dust, a foreign body or other contaminant gets on the lens or the lens
becomes dehydrated, the lens should be removed and replaced with a replacement lens.
• Eye care professionals should carefully instruct patients about the following safety
precautions. It is strongly recommended that patients be provided with a copy of the
Bausch & Lomb SofLens daily disposable Toric (hilafilcon B) 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 SofLens daily disposable
Toric (hilafilcon B) 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.
Topics to Discuss with the Patient:
Who Should Know That the Patient is Wearing Contact Lenses:
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.
• 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
their 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 insert a new lens. After
insertion of a new lens, if the problem continues, the patient should immediately remove the
lenses and consult their eye care professional.
If the above symptoms continue after removal of the 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 stinging 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.
SELECTION OF PATIENTS
The eye care professional should not fit patients who cannot or will not adhere to the
recommended replacement regimen or are unable to place and remove the lenses should not be
provided with them. Failure to follow handling 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 SofLens daily disposable Toric (hilafilcon B) 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 the eye care
professional 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 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 daily wear 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 prefitting examination should include spherocylinder refraction and VA, keratometry, and
biomicroscopic examination.
2. Initial Lens Power Selection
A. Select the initial trial lens from the Toric Diagnostic Lens Set with a power most similar
to the patients refractive needs, or order a diagnostic lens to the prescription which most
closely matches that of the patient.
B. Place the lens on the eye and 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.
C. 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. The toric diagnostic lens is used to optimize lens fitting characteristics and
determine axis orientation. Lens power is determined by the spectacle refraction.
• Rotation evaluation: The center guide mark should locate at the inferior limbus. Once
oriented, rotational rocking should be limited to less than 5°.
• Movement: The lens should provide discernible movement with:
– Primary gaze blink
– Upgaze blink
– Upgaze lag
• Centration: The lens should provide full corneal coverage.
B. Determine contact lens power. When the toric diagnostic lens does not have a power
equivalent to their spectacle Rx, Sphero-cylinder over-refractions will often be inaccurate
and confusing. Therefore it is usually preferable to use the spectacle Rx as the only basis
for the contact lens power. The sphere and cylinder power of the spectacle Rx becomes
the sphere and cylinder power of the contact lens. There are two exceptions:
1. If spectacle cylinder power falls between available contact lens cylinder powers,
prescribe the lesser contact lens cylinder power. The sphere power can be increased
-0.25D to compensate if desired. Of course this can vary depending on your
interpretation of the patient’s subjective responses.
Example:
Spectacle Rx -2.00 -1.00 X 180
Contact Lens Power Ordered -2.25 -0.75 X 180
2. When the spectacle lens power in any principle meridian is greater than 4.00D, the
spectacle refraction should be vertexed to the corneal plane. This can affect both the
sphere and cylinder powers ordered.
Example:
Spectacle Rx -5.00 -1.75 X 180
Contact Lens Power Ordered -4.75 -1.25 X 180
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.
With your finger, gently rotate the lens approximately 45° to the temporal side. It should
reorient within 5 to 10 blinks back to the same stabilized position.
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.
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.
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.
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.
PROFESSIONAL FITTINg SETS
Lenses must be discarded after 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 lens is to
be prescribed for single-use disposable wear, and is to be discarded after each removal.
MONOVISION FITTINg gUIDELINES
1. Patient Selection
A. Monovision Needs Assessment
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 two [2] diopters) in one eye may not be a good candidate for
monovision with the Bausch & Lomb SofLens daily disposable Toric (hilafilcon B) Visibility
Tinted Contact Lenses Contact Lens.
Occupational and environmental visual demands should be considered. If the patient
requires critical vision (visual acuity and stereopsis) it should be determined by trial
whether this patient can function adequately with monovision. Monovision contact lens
wear may not be optimal for such activities as:
(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.
B. Patient Education
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, as well as other presbyopic
contact lenses, or other alternative, 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.
2. Eye Selection
Generally, the non-dominant eye is corrected for near vision. The following tests 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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