Patient information: uses, side effects, how to take - ACUVUE Theravision with Ketotifen
DOSAGE AND ADMINISTRATION
- Insert one lens per eye per day. Discard lens after a single day's use.
- If prevention or relief of itching is needed beyond twelve hours, remove ACUVUE® Theravision™ with Ketotifen and consult your eye care professional.
- ACUVUE® Theravision™ with Ketotifen may be worn beyond twelve hours for vision correction. Lenses should be removed prior to sleeping.
ADDITIONAL INFORMATION
- The maximum daily wearing time should be determined by the Eye Care Professional based upon the patient's individual response to contact lenses. Regular checkups, as determined by the Eye Care Professional, are also extremely important.
- Patients tend to over wear the lenses initially. The Eye Care Professional should emphasize the importance of adhering to the initial maximum daily wearing time. Maximum wearing time should be determined by the Eye Care Professional based upon the patient's physiological eye condition, because individual response to contact lenses varies.
- ACUVUE® Theravision™ with Ketotifen is intended to be worn once on a daily disposable basis (less than 24 hours, while awake) and should be discarded upon removal. Studies have not been performed to show that ACUVUE® Theravision™ with Ketotifen is safe to wear during sleep.
- Patients should never wear lenses beyond the period recommended by the Eye Care Professional.
REPLACEMENT SCHEDULE
- These lenses are indicated for disposable wear and should be discarded upon removal.
LENS CARE DIRECTIONS
For Lenses Prescribed for Single Use Disposable Wear:
- The Eye Care Professional should review with patients that no cleaning or disinfection is needed with disposable lenses. Patients should always dispose of lenses when they are removed and have replacement non-medicated lenses or spectacles available.
Care for Sticking (Non-Moving) Lenses
- During removal, if the lens sticks to the eye, the patient should be instructed to apply a few drops of non-preserved sterile saline solution directly to the eye and wait until the lens begins to move freely on the eye before removing it. If non-movement of the lens continues after a few minutes, the patient should immediately contact the Eye Care Professional.
STORAGE CONDITIONS
Store at 15°C to 25°C (59°F to 77°F); with excursions permitted up to 30°C (86°F).
Protect from light. Store lenses in carton until use.
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 PROFESSIONAL OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY.
REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in patients wearing these lenses or experienced with the lenses should be reported to:
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, Florida 32256, USA
www.acuvue.com
©Johnson & Johnson Vision Care, Inc. 2021
In Canada: Johnson & Johnson Vision Care, division of Johnson & Johnson, Inc.
In USA: Johnson & Johnson Vision Care, Inc.
Printed in USA
Revision date: 2/2022
Revision number: XXXXXX
ACUVUE® Theravision™ is a trademark of Johnson & Johnson Vision Care, Inc.
ACUVUE®
Theravision™ with Ketotifen
(etafilcon A drug-eluting contact lens with ketotifen)
Contact lenses for daily wear (1-Day)
Contents: 30 etafilcon A drug-eluting contact lenses (59% H2O) in a buffered ketotifen solution. Each lens contains 19 mcg ketotifen.
PATIENT INSTRUCTION GUIDE
Rx Only
CAUTION: US Federal law restricts this device to sale by or on the order of a licensed practitioner
Dosage: See prescribing information
Light sensitive. Store blister packages in the carton until use
USA= Johnson & Johnson Vision Care, Inc., Jacksonville, FL 32256, USA
IRELAND= Johnson & Johnson Vision Care Ireland UC, Limerick, Ireland
© 2021 Johnson & Johnson Vision Care Companies
www.acuvue.com
SYMBOLS KEY
The following symbols may appear on the label or packaging:
| SYMBOL | DEFINITION |
|---|---|
 | Caution, Consult Instructions for Use |
 | Manufacturer |
 | Date of Manufacture |
 | Use by Date (expiration date) |
 | Batch Code |
 | Sterilized Using Steam Heat |
 | Do Not Re-Use (Single Use) |
 | Do Not Use if Package is Damaged |
 | Store Away from Direct Sunlight |
 | Indicates a Single Sterile Barrier System |
 | Authorized Representative in the European Community |
 | Medical Device in the European Community |
 | Fee Paid for Waste Management |
 | CE-mark and Identification Number of Notified Body |
 | Contains Hazardous Substances |
 | Contains a Medicinal Substance |
 | CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed practitioner |
| CONTACT LENS | Contact Lens |
 | Lens Orientation Correct |
 | Lens Orientation Incorrect (Lens Inside Out) |
 | Package Opening Icon (Blister) |
| DIA | Diameter |
| BC | Base Curve |
| D | Diopter (Lens Power) |
INDICATIONS
ACUVUE® Theravision™ with Ketotifen are daily wear, daily disposable drug-eluting contact lenses containing an antihistamine to prevent ocular itch due to allergic conjunctivitis and correction of refractive ametropia (myopia and hyperopia) in patients who do not have red eye(s), are suitable for contact lens wear and do not have more than 1.00 D of astigmatism. Itchy eye prevention has been demonstrated to last up to 12 hours in clinical trials; however, the lens may be worn for longer than 12 hours for vision correction.
WEARING INSTRUCTIONS
DO NOT WEAR YOUR LENSES WHILE SLEEPING.
The ACUVUE® Theravision™ with Ketotifen described in this booklet are prescribed by your Eye Care Professional for daily disposable wear and are to be discarded after each removal. You should:
- Insert one lens per eye per day. Discard lens after a single day's use.
- If prevention or relief of itching is needed beyond twelve hours, consult your Eye Care Professional.
- These lenses may be worn beyond twelve hours for vision correction. Lenses should be removed prior to sleeping.
- Do not use contact lens cleaning and disinfectant solutions with ACUVUE® Theravision™ with Ketotifen.
WHEN LENSES SHOULD NOT BE WORN (CONTRAINDICATIONS)
DO NOT USE these lenses when you have any of the following conditions:
- Red or irritated eye(s). Remove contact lens(es) immediately if eye(s) become red while wearing;
- Inflammation or infection in or around the eye or eyelids
- Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids
- Any previously diagnosed condition that makes contact lens wear uncomfortable
- Severe dry eye
- Reduced corneal sensitivity
- Any medical condition that may affect the eye or be made worse by wearing contact lenses
- Allergic reactions on the surface of the eye or surrounding tissues that may be induced or made worse by wearing contact lenses
- Any active eye infection
- Known hypersensitivity to any ingredient in this product
WARNINGS
What You Should Know About Contact Lens Wear:
EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP RAPIDLY AND LEAD TO LOSS OF VISION. IF YOU EXPERIENCE:
- Eye Discomfort,
- Excessive Tearing,
- Vision Changes,
- Loss of Vision,
- Eye Redness, or
- Other Eye Problems,
YOU SHOULD IMMEDIATELY REMOVE THE LENSES, AND PROMPTLY CONTACT YOUR EYE CARE PROFESSIONAL.
- These lenses should not be used to treat red eye(s). Remove lens(es) immediately if your eyes become red or irritated.
- Lenses prescribed for daily disposable wear (i.e., your Eye Care Professional instructs you to remove and discard your lenses at the end of each day), should not be worn while sleeping. Clinical studies have shown the risk of serious eye problems is increased when lenses are worn overnight.
- Contact lens wearers who are smokers have a higher incidence of corneal ulcers than nonsmokers.
- Problems with contact lenses or lens care products could result in serious injury to the eye.
- Proper use and care of your contact is essential for the safe use of these products.
- The overall risk of serious eye problems may be reduced by carefully following directions for lens care.
Specific Instructions for Use and Warnings:
Water Activity
Instruction for Use
Do not expose your contact lenses to water while you are wearing them.
WARNING:
Water can harbor microorganisms that can lead to severe infection, vision loss, or blindness. If your lenses have been submersed in water when participating in water sports or swimming in pools, hot tubs, lakes, or oceans, you should discard them and replace them with a new pair. Ask your Eye Care Professional for recommendations about wearing your lenses during any activity involving water.
PRECAUTIONS
For your eye health, it is important to carefully follow the handling, insertion, removal, and wearing instructions in this booklet, as well as those prescribed by your Eye Care Professional (see "Lens Handling & Insertion", "Lens Wearing" and "Caring for your Lenses" sections).
General Precautions:
Do Not use contact lens care solutions with this product
If you wear your contact lenses to correct presbyopia using monovision you may not be able to get the best corrected visual acuity for either far or near vision. Visual needs are different for different people, so your Eye Care Professional should work with you when selecting the most appropriate type of lens for you.
Always contact your Eye Care Professional before using any medicine in your eyes.
Be aware that certain medications, such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, oral contraceptives, and those for motion sickness may cause dryness of the eye, increased lens awareness (feeling of the lens in the eye), or blurred vision. Always inform your Eye Care Professional if you experience any problems with your lenses while taking such medications.
Do not change lens type (e.g. brand name, etc.) or parameters (e.g. diameter, base curve, lens power, etc.) without consulting your Eye Care Professional.
Consult your Eye Care Professional or Health Care Provider if you are pregnant or nursing a baby.
As with any contact lens, follow-up visits are necessary to assure the continuing health of your eyes. Ask your Eye Care Professional about the recommended follow-up schedule.
Who Should Know That You are Wearing Contact Lenses:
Inform all of your doctors (Health Care Professionals) about being a contact lens wearer.
Always inform your employer of being a contact lens wearer. Some jobs may require use of eye protection equipment or may require that you not wear contact lenses.
ADVERSE REACTIONS
(POSSIBLE PROBLEMS WITH LENS WEAR AND WHAT TO DO)
Possible Problems
The most commonly observed ocular adverse reactions in clinical studies, occurring in < 2% of treated eyes, were eye irritation, eye pain, and instillation site irritation.
Other potential lens related side effects are discussed in greater detail in other sections of this guide:
Risk of Developing Corneal Ulcers (See WARNINGS)
Other Contact Lens Related Problems
Be aware that problems can occur while wearing contact lenses and may be associated with the following symptoms:
- burning, stinging, itchy, and/or dry eyes
- reduced lens comfort
- feeling of something in your eye (foreign body, scratched area)
- swelling or inflammation in or around the eyes
- eye redness
- eyelid problems
- watery eyes and/or unusual eye secretion
- poor vision
- blurred vision
- rainbows or halos around objects
- sensitivity to light (photophobia)
When any of the above symptoms occur, a serious eye condition may be present. You should immediately be seen by your Eye Care Professional, so that the problem can be identified and treated, if necessary, in order to avoid serious eye damage.
This product should not be used to treat or prevent lens-related symptoms including irritation, discomfort, or redness.
Recognizing Problems and What To Do
You should conduct a simple 3-part self-examination at least once a day. Ask yourself:
- How do the lenses feel on my eyes?
- How do my eyes look?
- Have I noticed a change in my vision?
If you notice any problems, you should IMMEDIATELY REMOVE YOUR LENS AND CONTACT YOUR EYE CARE PROFESSIONAL.
LENS HANDLING AND INSERTION
For your eye health, it is important to carefully follow the handling, insertion, removal, and wearing instructions in this booklet, as well as those prescribed by your Eye Care Professional. If you will not or cannot always follow the recommended care procedures, you should not attempt to wear contact lenses.
When you first get your lenses, be sure that you are able to put the lenses on and remove them (or have someone else available who can remove the lenses for you) before leaving your Eye Care Professional's office.
Step 1: Getting Started
It is essential that you learn and use good hygiene in the care and handling of your new lenses.
Cleanliness is the first and most important aspect of proper contact lens care. In particular, your hands should be clean, dry, and free of any soaps, lotions, or creams before you handle your lenses.
Before you start:
Always wash your hands thoroughly with a mild soap, rinse completely, and dry with a lint-free towel before touching your lenses.
You should avoid the use of soaps containing cold cream, lotion, or cosmetics before handling your lenses. These substances may come into contact with the lenses and interfere with successful wearing. It is best to put on your lenses before putting on makeup
Step 2: Opening the Packaging
Multi-pack
Always confirm the lens parameters (e.g. diameter (DIA), base curve (BC), lens power (D), etc.) printed on the multi-pack and on the individual lens package match your prescription. DO NOT use if there is a mismatch.
Each multi-pack contains individually packaged lenses. Each lens comes in its own lens package designed specifically to keep it sterile while sealed.
These lenses are sensitive to light – store individual blister packages in the carton until use.
Lens Package
DO NOT use if the sterile blister package is opened or damaged.
To open an individual lens package, follow these simple steps:
- 1. Shake the lens package and check to see that the lens is floating in the solution.
- 2. Carefully peel back the foil closure to reveal the lens.
- 3. Place a finger on the lens and slide the lens up the side of the bowl of the lens package until it is free of the container.
Occasionally, a lens may stick to the inside surface of the foil when opened, or to the plastic package itself. This will not affect the sterility of the lens. It is still perfectly safe to use. Carefully remove and inspect the lens following the handling instructions.
NEVER use tweezers or other tools to remove your lenses from the lens container.
Lens Handling Tips
- Handle your lenses with your fingertips, and be careful to avoid contact with fingernails. It is helpful to keep your fingernails short and smooth.
- Develop the habit of always working with the same lens first to avoid mix-ups.
- After you have removed the lens from the packaging, examine it to be sure that it is a single, moist, clean lens that is free of any nicks or tears. If the lens appears damaged, DO NOT use it.
Step 3: Placing the Lens on the Eye
Remember, always start with the same eye.
Once you have opened the lens package, removed, and examined the lens, follow these steps to insert the lens into your eye:
- 1.
BE SURE THE LENS IS NOT INSIDE-OUT by following one of the following procedures:
- Place the lens on the tip of your index finger and check its profile. The lens should assume a natural, curved, bowl-like shape. If the lens edges tend to point outward, the lens is inside out.
Gently squeeze the lens between the thumb and forefinger. The edges should turn inward. If the lens is inside out, the edges will turn slightly outward.
OR
- Place the lens on the tip of your index finger and, looking up at the lens, locate the numbers 1-2-3. 1-2-3 indicates correct orientation, while a reverse of 1-2-3 indicates the lens is inside out. If the lens is inside out (reverse 1-2-3), invert the lens and locate the numbers again to confirm correct lens orientation.
- 2. With the lens on your index finger, use your other hand to hold your upper eyelid so you won't blink.
- 3. Pull down your lower eyelid with the other fingers of your "inserting" hand.
- 4. Look up at the ceiling and gently place the lens on the lower part of your eye.
- 5. Slowly release your eyelid and close your eye for a moment.
- 6. Blink several times to center the lens.
- 7. Use the same technique when inserting the lens for your other eye.
There are other methods of lens placement. If the above method is difficult for you, ask your Eye Care Professional for an alternate method.
Step 4: Checking Your Lenses
After you have successfully inserted your lenses, you should ask yourself:
- Do I see well?
- How do the lenses feel on my eyes?
- How do my eyes look?
If after placement of the lens, your vision is blurred, check for the following:
The lens is not centered on the eye (see " Step 5: Centering the Lens," next in this booklet).
If the lens is centered, remove the lens (see "Removing Your Lenses") and check for the following:
- Cosmetics or oils on the lens. Dispose of the lens and insert a new fresh lens.
- The lens is on the wrong eye.
- The lens is inside out (it would also not be as comfortable as normal). See "Step 3: Placing the Lens on the Eye."
If you find that your vision is still blurred after checking the above possibilities, remove the lens and consult your Eye Care Professional.
Note: If a lens is noticeably uncomfortable upon insertion or becomes less comfortable than when it was first inserted, remove the lens immediately and contact your Eye Care Professional. If your examination of your eyes and the lenses shows any other problems, IMMEDIATELY REMOVE YOUR LENSES AND CONTACT YOUR EYE CARE PROFESSIONAL.
Step 5: Centering the Lens
A lens, which is on the cornea (center of your eye), will very rarely move onto the white part of the eye during wear. This, however, can occur if insertion and removal procedures are not performed properly. To center a lens, follow either of these procedures:
Close your eyelids and gently massage the lens into place through the closed lids.
OR
- Gently move the off-centered lens onto the cornea (center of your eye) while the eye is opened using finger pressure on the edge of the upper lid or lower lid.
LENS WEARING
While wearing your lenses, remember the following important precautions:
Hazardous Conditions
If you use aerosol (spray) products, such as hair-spray, while wearing lenses, keep your eyes closed until the spray has settled.
Avoid all harmful or irritating vapors and fumes while wearing lenses.
Never rinse your lenses in water from the tap. Tap water contains many impurities that can contaminate or damage your lenses and may lead to eye infection or injury.
Water Activity
- Do not expose your contact lenses to water while you are wearing them.
Lubricating/Rewetting Solutions
Lubricating/Rewetting Solutions should not be used with these lenses. If the lens sticks (stops moving), a few drops of non-preserved sterile saline may be applied to assist with removal.
Do not use saliva or anything other than the recommended solutions for lubricating or rewetting your lenses. Do not put lenses in your mouth.
Sharing Lenses
Never allow anyone else to wear your lenses. Sharing lenses greatly increases the chance of eye infections.
Adhering to the Prescribed Wearing & Replacement Schedules
Never wear your lenses beyond the amount of time recommended by your Eye Care Professional. Never wear more than one lens per day.
Always throw away worn lenses as prescribed by your Eye Care Professional.
REMOVING YOUR LENSES
CAUTION: Always be sure the lens is on the cornea (center of your eye) before attempting to remove it. Determine this by covering the other eye. If vision is blurred, the lens is either on the white part of the eye or it is not on the eye at all. To locate the lens, inspect the upper area of the eye by looking down into a mirror while pulling the upper lid up. Then inspect the lower area by pulling the lower lid down.
- 1.
Wash, rinse, and dry your hands thoroughly. You should follow the method that is recommended by your Eye Care Professional. Below is an example of one method: the Pinch Method.
- Pinch Method:
- Step 1. Look up, slide the lens to the lower part of the eye using the forefinger.
- Step 2. Gently pinch the lens between the thumb and forefinger.
- Step 3. Remove the lens.
- 2. Follow the instructions in the next section, "Caring for Your Lenses".
NOTE: For your eye health, it is important that the lens moves freely on your eye. If the lens sticks (stops moving) on your eye, apply a few drops of the recommended rewetting solution. Wait until the lens begins to move freely on the eye before removing it. If non-movement of the lens continues, you should immediately consult your Eye Care Professional.
CARING FOR YOUR LENSES
Remember, there is no cleaning or disinfection needed with these lenses. Always dispose of lenses when they are removed and have replacement non-medicated lenses or glasses available. Any unused product or waste material should be disposed of in accordance with local requirements.
Lens Storage:
- Store these lenses at room temperature
- These lenses are sensitive to light – store individual blister packages in the carton until use.
EMERGENCIES
If chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are splashed into your eyes: FLUSH EYES IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONTACT YOUR EYE CARE PROFESSIONAL OR VISIT A HOSPITAL EMERGENCY ROOM RIGHT AWAY.
INSTRUCTIONS FOR THE PRESBYOPIC PATIENT
The decision to be fit with monovision correction is most appropriately left to your Eye Care Professional, in conjunction with you, after carefully considering and discussing your needs.
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA
Tel: 1-800-843-2020
www.acuvue.com
© Johnson & Johnson Vision Care, Inc. 2021
In Canada: Johnson & Johnson Vision Care division of Johnson & Johnson Inc.
In USA: Johnson & Johnson Vision Care, Inc
Revision Date: 2/2022
Revision number: XXXXX