DESCRIPTION

The Cibasoft Softcolors (tefilcon) Soft (hydrophilic) Contact Lenses are available as a spherical lens. Cibasoft Softcolors are tinted with a patented process. Cibasoft Softcolors are modified by permanently fixing tints to the polymer using the following color additives(either alone or in combination): Reactive Blue 21, reactive Black 4, Reactive Yellow 15,Reactive Orange 78, and Reactive Blue 19,and Reactive Red 180.Then optical and fitting characteristics are not altered by the tint process.Cibasoft Softcolors Contact Lenses are a hemispherical shell of the following dimensions:

• Diameter: ................................. 13.8mm and 14.5mm
• Center Thickness:

  low minus lens - varies with power
  (e.g., -3.00D: 0.070mm) Cibasoft Softcolors
  

  plus lens - varies with power
  (e.g., +3.00D: 0.140mm) Cibasoft Softcolors

• Base Curve: ...............................8.3, 8.6, 8,9mm in 13.8mm only
• Base Curve.................................8.6, 8.9, 9.2 (14.5 dia only**)
• Powers:

  Daily Wear ..+6.00D to -6.50D, 0.25 steps
  .......................-6.50D to -10.00D, 0.50 steps

  14.5 dia only** in plus

• The physical/optical properties of the lens are:
  
• Specific Gravity (calculated): 0.98 - 1.12
• Refractive Index: 1.415
• Surface Character: Hydrophilic
• Water Content: 37.5% in normal saline
• Light Transmittance: 85% minimum

• Oxygen Permeability:

VALUE	METHOD
8.9 x 10 -11 (cm 2/sec) (ml O2/ml x mm Hg) at 23oC	Fatt (boundary corrected, non-edge corrected)

Currently available lens parameters (Cibasoft Softcolors)

Base Curve	Diameter	Power Range
Minus
8.3mm, 8.6mm, 8,9mm	13.8mm	-0.25D to -6.50D (in 0.25D increments) -6.50D to -10.00D (in .25D increments)
Plus
8.6mm, 8.9mm, 9.2mm	14.5mm	+0.25D to +6.00D (in 0.25D increments)

ACTIONS

In its hydrated state, Cibasoft Softcolors Contact Lenses, when placed on the cornea, acts as a refracting medium to focus light rays on the retina.

INDICATIONS (USES)

The Cibasoft Softcolors Contact Lenses (spherical) are indicated for daily for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The contact lenses may be prescribed for daily wear 30 days wear (less than 1 day while awake) before replacement or as recommended by the Eye Care Practitioner. Eye Care Practitioners may prescribe the lenses either for daily wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see "Wearing Schedule"). When prescribed for frequent/planned replacement wear, the contact lenses may be disinfected using a chemical disinfection system only.

CONTRAINDICATIONS (REASONS NOT TO USE)

• Acute or 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), if non-aphakic
• Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses
• Allergic reactions of ocular surfaces or adnexa 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 Cibasoft Softcolors Contact Lenses
• Any active corneal infection (bacterial, fungal, protozoal or viral)
• If eyes become red or irritated

WARNINGS

Problems with contact lenses or lens care products could result in serious injury to the eye. Patients should be cautioned that proper use and care of contact lenses and lens care products, including lens cases, are essential for the safe use of these products. Patients should be advised of the following warnings pertaining to contact lens wear:

Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision. The results of a study¹ indicate the following:

• The overall annual incidence of ulcerative keratitis in daily wear contact lens users is estimated to be about 4.1 per 10,000 persons and about 20.9 per 10,000 persons in extended wear contact lens users.
• The risk of ulcerative keratitis is 4 to 5 times greater for extended wear contact lens users than for daily wear users. When daily wear users who wear their lenses overnight and extended wear users who wear their lenses on a daily basis are excluded from the comparison, the risk among extended wear users is 10 to 15 times greater than among daily wear users.
• When daily wear users wear their contact lenses overnight (outside the approved indication), the risk of ulcerative keratitis is 9 times greater than among those who do not wear them overnight.
• The overall risk of ulcerative keratitis may be reduced by carefully following directions for lens care, including cleaning the lens case.
• The risk of ulcerative keratitis among contact lens users who smoke is estimated to be 3 to 8 times greater than among nonsmokers.

If patients experience eye discomfort, excessive tearing, vision changes, redness of the eye or other problems, they should be instructed to immediately remove their contact lenses and promptly contact their Eye Care Practitioner. It is recommended that contact lens wearers see their Eye Care Practitioner routinely as directed.

1 New England Journal of Medicine, September 21, 1989

PRECAUTIONS

Special Precautions for Eye Care Practitioners

• 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 contact lens design and parameters, the Eye Care Practitioner should consider all characteristics of the contact lens that can affect contact 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 contact lens performance on the eye should be carefully monitored by the prescribing Eye Care Practitioner.

• Patients who wear contact lenses to correct presbyopia using monovision may not achieve the best corrected visual acuity for either far or near vision. Visual requirements vary with the individual and should be considered when selecting the most appropriate type of contact lens for each patient.
• Fluorescein, a yellow dye, should not be used while the contact lenses are on the eyes. The contact lenses absorb this dye and become discolored. Whenever fluorescein is used in eyes, the eyes should be flushed with a sterile saline solution that is recommended for in-eye use.
• Before leaving the Eye Care Practitioner's office, the patient should be able to promptly remove the contact lenses or should have someone else available who can remove the contact lenses for him or her.
• Eye Care Practitioners should instruct the patient to remove the contact lenses immediately if the eyes become red or irritated.

  Eye Care Practitioners should carefully instruct frequent replacement contact lens wear patients about the following care regimen and safety precautions:

• Different solutions cannot always be used together and not all solutions are safe for use with all contact lenses. Use only recommended solutions.

  -Never use solutions recommended for conventional hard contact lenses only.

  -Chemical disinfection solutions should not be used with heat unless specifically indicated on product labeling for use in both heat and chemical disinfection.

  -Always use fresh, unexpired lens care solutions and contact lenses.

  -Always follow directions in the package inserts for the use of contact lens solutions.

  -Use only a chemical (not heat) contact lens care system. Use of a heat (thermal) care system can damage the Cibasoft Softcolors Contact Lens.

  -Sterile unpreserved solutions, when used, should be discarded after the time specified in the labeling directions.

  -Do not use saliva or anything other than the recommended solutions for lubricating or wetting lenses.

  -Always keep the contact lenses completely immersed in the recommended storage

  solution when the contact lenses are not being worn (stored). Prolonged periods of

  drying will reduce the ability of the lens surface to return to a wettable state. Follow the lens care directions in "Care For A Dried Out (Dehydrated) Contact Lens" if lens surface does become dried out.

• If the contact lens sticks (stops moving) on the eye, follow the recommended directions in "Care for a Sticking Contact Lens". The contact lens should move freely on the eye for the continued health of the eye. If non-movement of the contact lens continues, the patient should be instructed to immediately consult his or her Eye Care Practitioner.
• Always wash and rinse hands before handling contact lenses. Do not get cosmetics, lotions, soaps, creams, deodorants or sprays in the eyes or on the lenses. It is best to put on contacts lenses before putting on makeup. Water-based cosmetics are less likely to damage contact lenses than oil-based products.
• Do not touch contact lenses with the fingers or hands if the hands are not free of foreign materials, as microscopic scratches of the contact lenses may occur, causing distorted vision and/or injury to the eye.
• Carefully follow the handling, insertion, removal, cleaning, disinfecting, storing and wearing instructions in the "Patient Instruction Guide" for the Cibasoft Softcolors Contact Lens and those prescribed by the Eye Care Practitioner.
• Never wear contact lenses beyond the period recommended by the Eye Care Practitioner.
• If aerosol products, such as hair spray, are used while wearing contact lenses, exercise caution and keep eyes closed until the spray has settled.
• Always handle contact lenses carefully and avoid dropping them.
• Avoid all harmful or irritating vapors and fumes while wearing contact lenses.
• Ask the Eye Care Practitioner about wearing contact lenses during sporting activities.
• Inform the doctor (health care practitioner) about being a contact lens wearer.
• Never use tweezers or other tools to remove contact lenses from the contact lens container unless specifically indicated for that use. Pour the contact lens and the packing solution into the hand.
• Do not touch the contact lens with fingernails.
• Always discard contact lenses worn on a disposable or frequent replacement schedule after the recommended wearing schedule prescribed by the Eye Care Practitioner.
• Always contact the Eye Care Practitioner before using any medicine in the eyes.
• Always inform the employer of being a contact lens wearer. Some jobs may require use of eye protection equipment or may require that the patient not wear contact lenses.
• Certain medications, such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers and those for motion sickness, may cause dryness of the eye, increased contact lens awareness or blurred vision. Should such conditions exist, proper remedial measures should be prescribed. Depending on the severity, this could include the use of lubricating drops that are indicated for use with soft contact lenses or the temporary discontinuance of contact lens wear while such medication is being used.
• Oral contraceptive users could develop visual changes or changes in contact lens tolerance when using contact lenses. Patients should be cautioned accordingly.
• 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.
• Due to the small number of patients enrolled in clinical investigation of lenses, all refractive powers, design configurations or contact lens parameters available in the lens material are not evaluated in significant numbers. Consequently, when selecting an appropriate contact lens design and parameters, the eye care practitioner should consider all characteristics of the contact lens that can affect contact lens performance and ocular health, including oxygen permeability, wettability, central and peripheral thickness and optic zone diameter.

ADVERSE REACTIONS

The patient should be informed that the following problems may occur when wearing contact lenses:

• The eye may burn, sting and/or itch.
• There may be less comfort than when the contact lens was first placed on the eye.
• There may be a feeling of something in the eye (foreign body, scratched area).
• There may be the potential for some temporary impairment due to peripheral infiltrates, peripheral corneal ulcers and corneal erosion. There may be the potential for other physiological observations, such as local or generalized edema, corneal neovascularization, corneal staining, injection, tarsal abnormalities, iritis and conjunctivitis, some of which are clinically acceptable in low amounts.
• There may be excessive watering, unusual eye secretions, or redness of the eye.
• Poor visual acuity, blurred vision, rainbows or halos around objects, photophobia, or dry eyes may also occur if the lenses are worn continuously or for too long a time.

The patient should be instructed to conduct a simple 3-part self examination at least once a day. They should ask themselves:

• How do the contact lenses feel on my eyes?
• How do my eyes look?
• Do I continue to see well?

If the patient reports any problems, he or she should be instructed to IMMEDIATELY REMOVE THE CONTACT LENS.

If the discomfort or problem stops, the patient should then look closely at the contact lens.

If the contact lens is in any way damaged, the patient SHOULD NOT put the contact lens back on the eye. The patient should discard the contact lens and insert a new fresh contact lens on the eye.

If the contact lens has dirt, an eyelash, or foreign body on it, or the problem stops and the contact lens appears undamaged, he or she should be instructed to dispose of the contact lens and insert a new fresh contact lens.

If the problem continues, the patient SHOULD NOT put the contact lens back on the eye but IMMEDIATELY CONSULT HIS OR HER Eye Care Practitioner.

The patient should be advised that when any of the above symptoms occur, a serious condition such as infection, corneal ulcer, neovascularization or iritis may be present. He or she should be instructed to seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage.

FITTING

Conventional methods of fitting contact lenses apply to the Cibasoft Softcolors (etafilcon A) Contact Lenses. For a detailed description of the fitting techniques, refer to the "Cibasoft Softcolors Contact Lenses Fitting and Patient Management Guide", copies of which are available from:

WEARING SCHEDULE

The wearing and replacement schedules should be determined by the Eye Care Practitioner. Patients tend to over wear the contact lenses initially. The Eye Care Practitioner should emphasize the importance of adhering to the initial maximum wearing schedule. Regular checkups, as determined by the Eye Care Practitioner, are also extremely important.

Ciba Vision recommends that the frequent replacement contact lens be discarded and replaced with a new contact lens every 2 weeks. However, the Eye Care Practitioner is encouraged to determine an appropriate contact lens replacement schedule based upon the response of the patient. The disposable contact lens should be discarded upon removal.

The Cibasoft Softcolors Contact Lenses are indicated for daily wear (less than 24 hours while awake) and for extended wear (greater than 24 hours, including while asleep).

DAILY WEAR

The maximum suggested wearing time for these contact lenses is:

EXTENDED WEAR

The Cibasoft Softcolors (etafilcon A) Contact Lens for Extended Wear is not recommended for continuous wear. Once the contact lens is removed, it is recommended that the patient's eyes should have a rest period of overnight or longer.

The wearing time of soft (hydrophilic) contact lenses used for extended wear should be determined by the Eye Care Practitioner.

It is recommended that the new contact lens wearer first be evaluated on a daily wear schedule. If, in the opinion of the Eye Care Practitioner, the patient is determined to be an acceptable extended wear candidate, the Eye Care Practitioner is encouraged to determine a wearing schedule based upon the response of the patient.

LENS CARE DIRECTIONS

FREQUENT REPLACEMENT LENS WEARERS: Eye Care Practitioners should review with the patient, contact lens care directions, including both basic lens care information and specific instructions on the contact lens care regimen recommended for the patient.

General Contact Lens Care (To First Clean and Rinse, Then Disinfect Contact Lenses)

Basic Instructions

• Always wash, rinse and dry hands before handling contact lenses.
• Always use fresh, unexpired lens care solutions.
• Use the recommended system of contact lens care, chemical (not heat), and carefully follow instructions on solution labeling. Different solutions cannot always be used together and not all solutions are safe for use with all contact lenses. Do not alternate or mix lens care systems unless indicated on solution labeling.
• Do not use saliva or anything other than the recommended solutions for lubricating or rewetting contact lenses. Do not put contact lenses in the mouth.
• Contact Lenses should be cleaned, rinsed and disinfected each time they are removed. Cleaning and rinsing are necessary to remove mucus and film from the contact lens surface. Disinfecting is necessary to destroy harmful germs.
• Always remove, clean, rinse, and disinfect contact lenses according to the schedule prescribed by the Eye Care Practitioner. Enzyme as frequently as recommended by the Eye Care Practitioner. The use of an enzyme or any cleaning solution does not substitute for disinfection.
• The Eye Care Practitioner should recommend a care system that is appropriate for the Cibasoft Softcolors Contact Lenses. Each contact lens care product contains specific directions for use and important safety information, which should be read and carefully followed.
• Note: Some solutions may have more than one function, which will be indicated on the label. Read the label on the solution bottle, and follow instructions.
• Clean one contact lens first (always the same contact lens first to avoid mix-ups), rinse the contact lens thoroughly with recommended saline or disinfecting solution to remove the cleaning solution, mucus and film from the contact lens surface, and put that contact lens into the correct chamber of the contact lens storage case. Repeat the procedure for the second contact lens.
• After cleaning, disinfect contact lenses using the system recommended by the manufacturer and/or the Eye Care Practitioner.
• To store contact lenses, disinfect and leave them in the closed/unopened case until ready to wear. If contact lenses are not to be used immediately following disinfection, the patient should be instructed to consult the package insert or the Eye Care Practitioner for information on storage of contact lenses.
• After removing the contact lenses from the contact lens case, empty and rinse thecontact lens storage case with solution as recommended by the lens case manufacturer; then allow the contact lens case to air dry. When the case is used again, refill it with storage solution. Replace contact lens case at regular intervals as recommended by the contact lens case manufacturer or your Eye Care Practitioner.
• Eye Care Practitioners may recommend a lubricating/rewetting solution which can be used to wet (lubricate)contact lenses while they are being worn to make them more comfortable.

CHEMICAL (NOT HEAT) DISINFECTION OF CONTACT LENSES WORN ON A FREQUENT REPLACEMENT SCHEDULE

• Clean the contact lenses with a recommended cleaning solution and thoroughly rinse them with a recommended rinsing solution.
• After cleaning, to disinfect, carefully follow the instructions accompanying the disinfecting solution in the care regimen recommended by the contact lens manufacturer or the Eye Care Practitioner.
• When using hydrogen peroxide contact lens care systems, lenses must be neutralized before wearing. Follow the recommendations on the hydrogen peroxide system labeling.
• Thoroughly rinse the contact lenses with a fresh solution recommended for rinsing before inserting and wearing, or follow the instructions on the disinfection solution labeling.
• Do not heat the disinfection solution and contact lenses.
• Leave the contact lenses in the unopened storage case until ready to put on the eyes.

Caution:

Contact lenses that are chemically disinfected may absorb ingredients from the disinfecting solution which may be irritating to the eyes. A thorough rinse in fresh sterile saline solution prior to placement on the eye should reduce the potential for irritation.

CONTACT LENS CASE CLEANING AND MAINTENANCE (Frequent Replacement Contact Lens Wearers Only)

Contact lens cases can be a source of bacteria growth. Contact Lens cases should be emptied, cleaned, rinsed with solutions recommended by the lens case manufacturer and allowed to air dry. Contact Lens cases should be replaced at regular intervals, as recommended by the lens case manufacturer or your Eye Care Practitioner.

CARE FOR A DRIED OUT (DEHYDRATED) CONTACT LENS

If the Cibasoft Softcolors frequent replacement contact lens is off the eye and exposed to air from 30 minutes to 1 hour or more, its surface will become dry and gradually become non-wetting. If this should occur, discard the contact lens and use a new one.

CARE FOR A STICKING (NON-MOVING) CONTACT LENS

If the Cibasoft Softcolors contact lens sticks (stops moving), the patient should be instructed to apply a few drops of the recommended lubricating or rewetting solution directly to the eye and wait until the contact lens begins to move freely on the eye before removing it. If non-movement of the contact lens continues after a few minutes, the patient should immediately consult the Eye Care Practitioner.

EMERGENCIES

The patient should be informed that if chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are splashed into the eyes, the patient should: FLUSH EYES IMMEDIATELY WITH TAP WATER and IMMEDIATELY CONTACT THE Eye Care Practitioner OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY.

HOW SUPPLIED

Each sterile contact lens is supplied in a foil-sealed plastic package containing buffered saline solution. The plastic package is marked with base curve, diopter power, diameter, color (visibility tint), lot number and expiration date.

REPORTING OF ADVERSE REACTIONS

All serious adverse experiences and adverse reactions observed in patients wearing Cibasoft Softcolors Contact Lenses or experienced with the contact lenses should be reported to: