*INDICATIONS AND BRIEF SAFETY INFORMATION for MiSight® 1 day soft contact lens:

INDICATIONS:

MiSight® 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear is a prescription device indicated for the correction of nearsightedness and for slowing the progression of nearsightedness in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism.
 

BRIEF SAFETY INFORMATION:

Problems can occur while wearing soft contact lenses that may result in serious injury to the eye. Proper use of contact lenses is essential for the safe use of these products. Follow your child’s eye care practitioner’s directions and all labeling instructions for proper use of lenses.   Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision.
 

Who Should Not Use MiSight® 1 day Soft Contact Lenses?

Do not let your child use their contact lenses when any of the following conditions exist:

  • Inflammation or infection of the front part of the eye.
  • Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
  • Severe dry eye.
  • Reduced corneal sensitivity – a condition in which the nerves in the front of the eye cannot feel sensation.
  • Allergic reactions of the eye or the skin surrounding the eye that may be caused by or made worse by wearing contact lenses or use of contact lens solutions.
  • Any active corneal infection (bacterial, fungal, or viral).
  • If eyes become red or irritated.
  • If your child is unable to properly handle the lenses or unable to obtain assistance to do so.
  • Any bodily disease which may affect the eye or be made worse by wearing contact lenses.


WARNINGS AND PRECAUTIONS:

What Else Should I Consider About MiSight® 1 day Contact Lens Wear?

MiSight® lenses provide an optical correction that simultaneously presents one image “in-focus” and a second image “out-of-focus.” Under certain circumstances (such as low light levels), this optical design can cause the following visual symptoms for some patients:

  • Reduced image contrast
  • A ghost image (double image, with a mild second image seen)
  • Halos around bright light; and
  • Glare around lights.

Not all patients do equally well with this type of correction. In some children, the visual symptoms described above may cause difficulties with some visually demanding activities. Patients should exercise extra care if performing potentially hazardous activities.
 

Water Activity:

  • Do not expose contact lenses to water while wearing them.
  • Water may contain microorganisms (germs) that can lead to severe infection, vision loss or blindness.
  • After swimming in pools, lakes, or oceans, have your child throw the lenses away and replace them with a new pair.
  • Ask your child’s eye care practitioner (professional) for recommendations about wearing the lenses during any activity involving water.


Handling Precautions:

  • Do not let your child use the lens if the sterile lens blister package is opened or damaged.
  • Always have your child wash and rinse hands before handling lenses.
  • Do not get cosmetics, lotions, soaps, creams, deodorant, or sprays in the eyes or on the lenses. It is best to put on lenses before putting on makeup. Water-based cosmetics are less likely to damage lenses than oil-based products.
  • Lens contamination may occur if your child handles their lens with dirty hands.
  • Have your child carefully follow the handling, insertion, removal, cleaning, and wearing instructions prescribed by their eye care practitioner.
  • Your child should always handle lenses gently and avoid dropping them.
  • Never let your child use tweezers or other tools to remove lenses from the lens container. They should put the lens and packaging solution into their hand.
  • Do not touch the lens with fingernails.


Lens Wearing Precautions:

  • Your child should never wear their lenses beyond the period recommended by their eye care practitioner.
  • Your child should avoid all harmful or irritating vapors and fumes while wearing lenses. If aerosol products such as hairspray are used while wearing lenses, your child needs to be careful and keep eyes closed until the spray has settled.
  • Ask your child’s eye care practitioner about wearing the lenses during sporting activities.
  • Have your child always discard lenses following the recommended wearing schedule prescribed by your child’s eye care practitioner.
  • Do not allow use of saliva for lubricating or wetting lenses.


What Are Key Complication Associated With Contact Lens Wear?

Be aware that the following problems may occur when wearing contact lenses:

  • Your child’s eyes may burn, sting and/or itch or your child may experience other eye pain.
  • Comfort may be less than when the lens was first placed on the eye.
  • There may be a feeling that something is in the eye such as a foreign body or a scratched area.
  • There may be excessive watering (tearing), unusual eye secretions, or redness of the eye.
  • Reduced sharpness of vision.
  • Sensitivity to light.
  • Dry eyes.

If you notice any of the above in your child, you should:

  • Immediately have your child remove the lenses.
  • If the discomfort or the problem stops, then replace the lens with a new lens.
  • If the problem continues, you should keep the lens off the eye and seek immediate professional care. Your child’s eye care practitioner will examine their eyes to be certain that a serious condition such as infection, abrasion, corneal ulcer, neovascularization (blood vessels in the clear front part of the eye), or iritis (inflammation of the colored part of the eye) is not present.

Eye problems, including corneal ulcers, can develop rapidly and can cause permanent or temporary loss of vision. When any of the above problems occur, it may be a symptom of a serious condition such as infection/ulcer of the cornea (the clear front part of the eye), inflammation of the cornea, abrasion or scratch of the cornea, swelling of the cornea, blood vessel growth into the cornea, conjunctivitis (pink eye), or inflammation, swelling or redness of other parts of the eye or eyelids.

If the following is experienced your child should be instructed to immediately remove the lenses, and you should promptly contact their eye care practitioner:

  • Eye discomfort
  • Too much tearing
  • Vision changes
  • Loss of vision
  • Eye redness
  • Or other eye problems


How Should My Child Use MiSight® 1 day Soft Contact Lenses?

Based on the clinical study, it is recommended that the patient wear the lens for a minimum of 10 hours per day for at least 6 days per week.

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 risk of serious adverse reactions is increased when these lenses are worn overnight.

Single use lenses are not intended for cleaning or re-use, and on removal should be thrown away and a fresh pair used each day. MiSight® 1 day (omafilcon A) Contact Lenses should be removed from your child’s eyes each day and discarded.

Studies have shown that contact lens wearers who are smokers have a higher likelihood of adverse reactions than nonsmokers.
 

Who Should Know That My Child is Wearing Soft Contact Lenses?

  • Inform your child’s doctor (health care practitioner) that your child is wearing contact lenses.


What Else Should I discuss with My Child’s Eye Care Practitioner?

  • Always contact your child’s eye care practitioner before using any medicine in their eyes.
  • Follow-up visits are necessary to assure the continued health of your child’s eyes. You should be instructed to follow a recommended follow-up schedule.
  • Although the clinical study of MiSight® lenses demonstrated decreased progression in nearsightedness during its three-year duration with the MiSight® lenses, any potential benefits beyond the three-year study, specifically with regard to the further slowing of nearsightedness or the prevention of future retinal disease have not been determined.
  • Certain subjects were restricted from taking part in the MiSight® 1 day clinical study: those children in whom contact lens wear might pose greater risks, and those children with characteristics that might reduce the effectiveness of the treatment. The safety and effectiveness of the use of the device in these types of patients is not known.


By prescription only.  Results may vary.  Please reference the Patient Information Booklet for a complete listing of Indications and Important Safety Information.