Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc.
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CR-6291, v1.0
 
 
Page 1 of 175
JJVC CONFIDENTIAL

TABLE OF CONTENTS
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CR-6291, v1.0
 
 
Page 2 of 175
JJVC CONFIDENTIAL

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Page 3 of 175
JJVC CONFIDENTIAL

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Page 4 of 175
JJVC CONFIDENTIAL

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TABLE OF CONTENTS
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JJVC CONFIDENTIAL

PROTOCOL TITLE, NUMBER, VERSION
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JJVC CONFIDENTIAL

SYNOPSIS 
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Page 9 of 175
JJVC CONFIDENTIAL

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Page 11 of 175
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Page 14 of 175
JJVC CONFIDENTIAL

1.
INTRODUCTION AND BACKGROUND
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1.1.
Name and Descriptions of Investigational Products 
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Intended Use of Investigational Products
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1.3.
Summary of Findings from Nonclinical Studies
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Summary of Known Risks and Benefits to Human Subjects
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Page 15 of 175
JJVC CONFIDENTIAL

1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
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STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
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Objectives 
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Page 16 of 175
JJVC CONFIDENTIAL

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TARGETED STUDY POPULATION
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General Characteristics 
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Page 17 of 175
JJVC CONFIDENTIAL

3.3.
Exclusion Criteria
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3.4.
Enrollment Strategy
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STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
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Page 18 of 175
JJVC CONFIDENTIAL

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Page 19 of 175
JJVC CONFIDENTIAL

1RPRUHWKDQRQHVWXG\YLVLWFDQRFFXURQDQ\JLYHQGD\FRQVHFXWLYHGD\VDUHDOORZHG7KH
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4.2.
Study Design Rationale
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4.3.
Enrollment Target and Study Duration
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5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
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Page 20 of 175
JJVC CONFIDENTIAL

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Masking
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Procedures for Maintaining and Breaking the Masking
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Page 21 of 175
JJVC CONFIDENTIAL

6.4.
Packaging and Labeling
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Storage Conditions
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Collection and Storage of Samples
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Page 39 of 175
JJVC CONFIDENTIAL

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Page 40 of 175
JJVC CONFIDENTIAL

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Page 41 of 175
JJVC CONFIDENTIAL

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Serious/Significant Adverse Events
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Page 42 of 175
JJVC CONFIDENTIAL

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14. STATISTICAL METHODS
14.1. General Considerations
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14.2. Sample Size Justification
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14.3. Analysis Populations
Safety Population:
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Per-Protocol Population: 
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JJVC CONFIDENTIAL

Intent-to-Treat (ITT) Population:
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14.4. Level of Statistical Significance
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14.5. Primary Analysis of Microsphere Uptake and Clearance by Lens Type
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14.6. Secondary Analysis of Microsphere Uptake and Clearance by Lens Movement, 
Corneal Curvature and Blink Rate 
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14.7. Other Exploratory Analyses
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14.8. Interim Analysis
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14.9. Procedure for Handling Missing Data and Drop-Outs
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14.10. Procedure for Reporting Deviations from Statistical Plan
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15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
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15.2. Subject Record
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JJVC CONFIDENTIAL

16. DATA MANAGEMENT
16.1. Access to Source Data/Document
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CR-6291, v1.0
 
 
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20. FINANCIAL CONSIDERATIONS
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22. REFERENCES
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 <RXQJ*+XQW&-RQHV6Final Report 
Clinical evaluation of 
silicone hydrogel lenses in 7-day extended wear.2FWREHU
 3RO\VW\UHQH0LFURVSKHUHV,%Y
 5HDG0/Clinical Study Report 
Use of microspheres to simulate 
particulate exchange in the post-lens tear film during contact lens wear)HEUXDU\

 8QLWHG6WDWHV86&RGHRI)HGHUDO5HJXODWLRQV&)5$YDLODEOHDW
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 .HQZDUG0*5RJHU-+Small sample inference for fixed effects 
from restricted maximum likelihood. Biometrics±
CR-6291, v1.0
 
 
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 5LW]PDQQ0&DUROLQH3-%RUUHW&.RUV]HQAn analysis of anterior scleral shape 
and its role in the design and fitting of scleral contact lenses. Cont Lens Anterior Eye
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CR-6291, v1.0
 
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)

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PRO SPECIFICATIO
 2 Final  2018-09-06
Protocol 6291                 Johnson & Johnson Vision Care, Inc.                  Confidential
1
CR-6291, v1.0
 
 
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PRO SPECIFICATIO
 2 Final  2018-09-06
Protocol 6291                 Johnson & Johnson Vision Care, Inc.                  Confidential
2
CR-6291, v1.0
 
 
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PRO SPECIFICATIO
 2 Final  2018-09-06
Protocol 6291                 Johnson & Johnson Vision Care, Inc.                  Confidential
3
CR-6291, v1.0
 
 
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PRO SPECIFICATIO
 2 Final  2018-09-06
Protocol 6291                 Johnson & Johnson Vision Care, Inc.                  Confidential
4
CR-6291, v1.0
 
 
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PRO SPECIFICATIO
 2 Final  2018-09-06
Protocol 6291                 Johnson & Johnson Vision Care, Inc.                  Confidential
5
CR-6291, v1.0
 
 
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PRO SPECIFICATIO
 2 Final  2018-09-06
Protocol 6291                 Johnson & Johnson Vision Care, Inc.                  Confidential
6
CR-6291, v1.0
 
 
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APPENDIX B: PATIENT INSTRUCTION GUIDE 
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

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Page 1 of 13 
 
 
 
 
 
 
 
 
 

PATIENT INSTRUCTION GUIDE 
 
Clinic Only Wear 
 
Soft (hydrophilic) Contact Lenses 
 
Study CR-6291 
 
 
 
 
 
 
 
 
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TABLE OF CONTENTS 
INTRODUCTION ............................................................................................................................................. 3 
SYMBOLS KEY ................................................................................................................................................ 4 
GLOSSARY OF COMMONLY USED TERMS ..................................................................................................... 5 
WEARING RESTRICTIONS & INDICATIONS .................................................................................................... 5 
REASONS YOU SHOULD NOT WEAR THE STUDY LENSES .............................................................................. 6 
POSSIBLE RISKS OR DISCOMFORTS RELATED TO THE STUDY ....................................................................... 6 
PRECAUTIONS………………………………………………………………………………………………………………………………………….7 
LENS HANDLING AND INSERTION ................................................................................................................. 7 
Step 1: Getting Started ........................................................................................................................... 8 
Step 2: Opening the Packaging ............................................................................................................... 8 
Step 3: Placing the Lens on the Eye ........................................................................................................ 9 
Step 4: Checking Your Lenses .................................................................................................................. 9 
Step 5: Centering the Lens .................................................................................................................... 10 
LENS WEARING ........................................................................................................................................... 10 
REMOVING YOUR LENSES ........................................................................................................................... 11 
EMERGENCIES ............................................................................................................................................. 12 
NOTES.......................................................................................................................................................... 12 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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INTRODUCTION 
About This Booklet: 
The information and instructions contained in this booklet apply only to your study contact 
lenses. 
For your eye health, it is important that your contact lenses be worn only as directed by your 
Study Investigator. Your Study Investigator should be kept fully aware of your medical. He or 
she will review with you all instructions for lens handling. This booklet will reinforce those 
instructions. 
 
If you have any questions, always ask your Study Investigator. 
 
A “Glossary of Commonly Used Terms” is included for your reference. This contains definitions 
of medical and technical terminology used in this booklet. In addition, a “Symbols Key” provides 
an explanation of symbols that may appear on the lens packaging.  
 
About Your Lenses and Contact Lens Wear: 
Your contact lenses are made from a water loving (hydrophilic) material that has the ability to 
absorb water, making the lenses soft and flexible. The lenses are tinted to improve visibility for 
handling and may also contain an ultraviolet (UV) radiation absorbing ingredient to block UV 
radiation. 
 
Your study contact lenses should be worn at the study site according to the wearing schedule 
prescribed by your Study Investigator. You should always have your regular glasses or contact 
lenses available.  
 
 
 
 
 
 
 
 
 
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REASONS YOU SHOULD NOT WEAR THE STUDY LENSES 
(PARTICIPATION CRITERIA) 
PARTICIPATION CRITERIA  
Participants who are in this study will need to have healthy eyes, except for the need to correct their 
eyesight. You should not be in this study if any of the following apply to you: 
x
You are currently pregnant or lactating (producing breast milk). 
x
You have any systemic (whole body) disease (such as Sjögren’s Syndrome), autoimmune disease 
(such as rheumatoid arthritis), or use of medication (such as chronic steroid use), which may 
interfere with contact lens wear. 
x
You have used topical medication, such as eye drops or ointment within 24 hours prior to the 
study visit. 
x
You have a history of anaphylaxis or severe allergy.  
x
You have any previous or planned (during the course of the study) ocular (eye) surgery (such as 
radial keratotomy, PRK, LASIK, etc.). 
x
You have participated in any contact lens or lens care product clinical trial within 14 days prior 
to study enrollment. 
x
You are an employee or immediate family member of clinical site (such as Investigator, 
Coordinator, Technician). 
x
You have any slit lamp findings of grade 3 or higher (e.g. corneal oedema, corneal 
neovascularization, tarsal abnormalities, conjunctival injection) or findings of < grade 3 which in 
the investigator’s opinion would contraindicate contact lens wear. 
 
POSSIBLE RISKS OR DISCOMFORTS RELATED TO THE STUDY 
What You Should Know About Contact Lens Wear and This Study: 
There are risks to using your own contact lenses (and related products) and as such, there are risks of 
participating in this study. The study contact lenses are CE marked - this means that they are approved 
for sale in the European Union. It is possible that the following may occur: pain, abrasion of the eye, the 
sensations of itching, burning or stinging, excessive tear production, unusual secretions, redness, 
reduced sharpness of vision, blurred vision, sensitivity to light or dry eyes. In rare instances, corneal 
ulcers, scarring, the growth of blood vessels into the cornea, temporary or permanent decreased vision, 
iritis or infections of the eye might occur. Further treatment may be required, and you may also be 
precluded from future contact lens wear. If you experience any of these, you should contact Eurolens 
Research as soon as possible by telephoning 0161 306 2132. 
In order to examine the surface of your eyes, we will apply sodium fluorescein, a yellow dye which is 
routinely used in a contact lens examination. Major side effects from the use of sodium fluorescein are 
very rare, but there are currently five reports of anaphylaxis worldwide. Other rare side effects can 
include slight stinging on instillation and temporary blurred vision. 
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No major side effects have been reported from topical installation of the microsphere suspension onto 
the ocular surface. Possible side effects may include slight stinging on instillation and temporarily 
blurred vision. 
Any benefit or assistance, which you would normally have access to, will not be withheld from you 
during the study. If new information becomes available during the course of the study that may affect 
your willingness to continue in the study, you will be informed. 
 
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 Study Investigator (see 
“Lens Handling & Insertion” and “Lens Wearing” sections).  
 
General Precautions: 
Always contact your Study Investigator before using any medicine in your eyes. 
Be aware that certain medications, such as antihistamines, decongestants, diuretics, muscle 
relaxants, tranquilizers 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 Study 
Investigator if you experience any problems with your lenses while taking such medications.  
Be aware that if you use oral contraceptives (birth control pills), you could develop changes in 
vision or comfort when wearing contact lenses. 
As with any contact lens, follow-up visits are necessary to assure the continuing health of your 
eyes. Ask your Study Investigator 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. 
 
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 Study Investigator. If 
you will not or cannot always follow the recommended care procedures, you should not 
attempt to wear contact lenses. 
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Step 1: Getting Started 
It is essential that you learn and use good hygiene in the care and handling of your study 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. 
DO NOT touch your contact lenses with your fingers or hands if they are not 
completely clean, because tiny lens scratches may occur, causing unclear vision 
and/or injury to your eye. 
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. 
DO NOT get cosmetics, lotions, soaps, creams, deodorants or sprays in your eyes or 
on your lenses.  
Start off correctly by getting into the habit of always using proper hygiene so that they become 
automatic. 
 
Step 2: Opening the Packaging 
Lens Package 
Each lens comes in its own lens package designed specifically to keep it sterile while sealed. 
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. Peel back the foil closure to reveal the lens. By stabilizing the lens package on the 
table-top, you will minimize the possibility of a sudden splash. 
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. 
NEVER use tweezers or other tools to remove your lenses from the lens 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. 
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Page 9 of 13 
Lens Handling Tips 
x
Handle your lenses with your fingertips, and be careful to avoid contact with 
fingernails. It is helpful to keep your fingernails short and smooth.  
DO NOT touch the lens with your fingernails. 
x
Develop the habit of always working with the same lens first to avoid mix-ups. 
x
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. The Study Investigator will replace the lens.  
ALWAYS handle lenses carefully and avoid dropping them.  
 
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 to your eye: 
1. BE SURE THE LENS IS NOT INSIDE-OUT by following one of the following procedures: 
x
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.  
x
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. 
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 
Study Investigator for an alternate method. 
 
Step 4: Checking Your Lenses 
After you have successfully inserted your lenses, you should ask yourself: 
x
Do I see well? 
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Page 10 of 13 
x
How do the lenses feel on my eyes? 
x
How do my eyes look? 
If after placement of the lens, your vision is blurred, consult your Study Investigator. 
 
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: 
x
Close your eyelids and gently massage the lens into place through the closed lids. 
OR 
x
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 
x
If you use aerosol (spray) products, such as hair spray, while wearing lenses, keep 
your eyes closed until the spray has settled.  
x
Never rinse your lenses in water from the tap. There are two reasons for this: 
1. Tap water contains many impurities that can contaminate or damage your lenses 
and may lead to eye infection or injury. 
2. You might lose your lens down the drain. 
 
Lubricating/Rewetting Solutions 
x
Your Study Investigator may recommend a lubricating/rewetting solution for your 
use. These solutions can be used to wet (lubricate) your lenses while you are 
wearing them. 
x
Do not use saliva or anything other than the recommended solutions for lubricating 
or rewetting your lenses. Do not put lenses in your mouth. 
 
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Page 11 of 13 
Sticking (Non-Moving) Lens 
x
For your eye health, it is important the lens moves freely on your eye.  
x
If the lens sticks (stops moving) on your eye, you should immediately consult your 
Study Investigator. 
 
Sharing Lenses 
x
Never allow anyone else to wear your lenses. Sharing lenses greatly increases the 
chance of eye infections.  
 
Adhering to the Prescribed Wearing Schedules 
x
Never wear your lenses beyond the amount of time recommended by your Study 
Investigator. 
 
REMOVING YOUR LENSES 
CAUTION: Always be sure the lens is on the cornea (in the 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.  
Always remove the same lens first. 
1. Wash, rinse and dry your hands thoroughly. You should follow the method that is 
recommended by your Study Investigator. 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. Remove the other lens by following the same procedure. 
Note: If these methods of removing your lens are difficult for you, ask your Study Investigator 
for an alternate method. 
Always have your regular glasses or contact lenses available. 
 
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EMERGENCIES 
If chemicals of any kind (household products, laboratory chemicals, etc.) are splashed into your 
eyes: FLUSH EYES IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONSULT YOUR STUDY 
INVESTIGATOR. 
 
NOTES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Page 13 of 13 
 
 
 
 
 
 
 
 
 
 
 
Sponsored By: 
Johnson & Johnson Medical Limited 
Pinewood Campus 
Nine Mile Ride 
Wokingham 
RG40 3EW 
United Kingdom 
Tel: 0800 022 4222 
 
 
 
 
 
 
 
 
 
©Johnson and Johnson Vision Care, Inc. 2018 
Revision date 09/2018 
 
Revision number: CAL-CR-6291-A (1) (English) 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)

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2
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IMPORTANT:Pleasereadcarefullyandkeepthisinformationforfutureuse...........3

Deutsch
WICHTIG:DieseGebrauchsinformationbittesorgfältiglesenundfürdenkünftigen
Gebrauchaufbewahren............................................................................................17

Nederlands
BELANGRIJK:leesdezeinformatiezorgvuldigdoorenbewaardezevoor
toekomstiggebruik....................................................................................................34

Türkçe
ÖNEML7:Lütfendikkatleokuyunvedahasonrakullanmaküzerebubilgileri
saklayŦn......................................................................................................................49



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
CONTENT

ACUVUE®BrandContactLensesareprovidedinsterileindividualblisterpackages,withthe
lensimmersedinbufferedsalinesolution(seeTable1forPackagingSolution).DONOTUSE
ifthesterileblisterpackageisopenedordamaged.

INTENDEDUSE

ACUVUE®SphericalBrandContactLenses

Are intended for Daily Wear or Extended Wear, as shown in Table 1, for the optical
correctionofrefractiveametropia(myopiaandhyperopia)inphakicoraphakicpersonswith
nonͲdiseasedeyesthatmayhave1.00Dorlessofastigmatism.

1•DAY ACUVUE® DEFINE® Brand Contact Lenses with LACREON® are also intended to
enhanceoraltertheappearanceoftheeye.

ACUVUE®BrandContactLensesforAstigmatism

Are intended for Daily Wear or Extended Wear, as shown in Table 1, for the optical
correctionofrefractiveametropia(myopiaandhyperopia)inphakicoraphakicpersonswith
nonͲdiseasedeyesthatmayhaveastigmatism.

ACUVUE®BrandContactLensesforPresbyopia

Are intended for Daily Wear or Extended Wear, as shown in Table 1, for the optical
correctionofrefractiveametropia(myopiaandhyperopia)inpresbyopic,phakicoraphakic
personswithnonͲdiseasedeyeswhohave0.75Dorlessofastigmatism.

Additionally, ACUVUE OASYS® Brand Contact Lenses with HYDRACLEAR® PLUS are also
indicatedfortherapeuticuseasabandagelensforthefollowingacuteandchronicocular
conditions:

x
For corneal protection in lid and corneal abnormalities such as entropion, trichiasis,
tarsalscarsandrecurrentcornealerosion.Inaddition,theyareindicatedforprotection
wheresuturesorocularstructuremalformation,degenerationorparalysismayresultin
theneedtoprotectthecorneafromexposureorrepeatedirritation.
x
Forcornealpainreliefinconditionssuchasbullouskeratopathy,epithelialerosionand
abrasion,filamentarykeratitis,andpostͲkeratoplasty.
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
x
For use as a barrier during the healing process of epithelial defects such as chronic
epithelialdefects,cornealulcer,neurotrophicandneuroparalytickeratitis,andchemical
burns.
x
Forpostsurgicalconditionswherebandagelensuseisindicatedsuchaspostrefractive
surgery,lamellargrafts,cornealflaps,andadditionalocularsurgicalconditions.
x
Forstructuralstabilityandprotectioninpiggybacklensfittingwherethecorneaand
associatedsurfacesaretooirregulartoallowforcornealrigidgaspermeable(RGP)lenses
to be fitted. In addition, the use of the lens can prevent irritation and abrasions in
conditions where there are elevation differences in the host/graph junction or scar
tissue.
ACUVUE OASYS® Brand Contact Lenses with HYDRACLEAR® PLUS when prescribed for
therapeuticusemaybewornforDailyWearorExtendedWear.
AllACUVUE®BrandContactLenseshaveUVBlockingtohelpprovideprotectionagainst
transmissionofharmfulUVradiationtothecorneaandintotheeye.

WARNING:UVabsorbingcontactlensesareNOTsubstitutesforprotectiveUVabsorbing
eyewear suchas UVabsorbinggogglesor sunglassesbecausetheydonotcompletely
covertheeyeandsurroundingarea.YoushouldcontinuetouseUVabsorbingeyewear
asdirected.

Note: LongͲterm exposure to UV radiation is one of the risk factors associated with
cataracts. Exposure is based on a number of factors such as environmental conditions
(altitude, geography, cloud cover) and personal factors (extent and nature of outdoor
activities).AllACUVUE®BrandContactLenseshaveUVblockingtohelpprovideprotection
againsttransmissionofharmfulUVradiationtothecorneaandintotheeye.However,
clinicalstudieshavenotbeendonetodemonstratethatwearingUVblockingcontactlenses
reduces the risk of developing cataracts or other eye disorders. Consult your Eye Care
Professionalformoreinformation.

WEARSCHEDULE

ThewearingandreplacementscheduleshouldbedeterminedbytheEyeCareProfessional.
Patients may tend to over wear the lenses initially. The Eye Care Professional should
emphasisetheimportanceofadheringtotheinitialmaximumwearingschedule.Regular
checkups,asdeterminedbytheEyeCareProfessional,arealsoextremelyimportant.



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DailyWearͲDailyDisposable

ACUVUE®BrandContactLensesprescribedforDailyWearͲDailyDisposable(lessthan24
hours,whileawake)asshowninTable1,areintendedtobewornonceonadailydisposable
basis and are to be discarded upon removal. When used in this way, no cleaning or
disinfectionisrequired.
1•DAY ACUVUE® TruEye® Brand Contact Lenses have not been developed for use with
contactlenscleanersordisinfectionsystems.Lensesshouldbediscardedafteruse.Start
eachwearingperiodwithafreshnewlens.
DailyWearͲFrequentReplacement
AllACUVUE®Vita™BrandContactLensesprescribedforDailyWear–FrequentReplacement
(lessthan24hours,whileawake)asshowninTable1,aretobediscardedandreplaced
everymonth.
AllotherACUVUE®BrandContactLensesprescribedforDailyWearͲFrequentReplacement,
aretobediscardedandreplacedeverytwoweeks.
AllACUVUE®BrandContactLensesasshowninTable1,undertheheadingofDailyWearͲ
Frequent Replacement are to be cleaned, rinsed and disinfected each time the lens is
removedusingachemicaldisinfectionsystemonly.

ExtendedWear

ACUVUE® Brand Contact Lenses prescribed for Extended Wear, (greater than 24 hours,
includingwhileasleep)asshowninTable1,maybeusedcontinuouslyforupto7days/6
nights and should be discarded upon removal. When used in this way, no cleaning or
disinfectionisrequired.

ItisrecommendedthatthenewcontactlenswearerfirstbeevaluatedonaDailyWearͲ
FrequentReplacementschedule.IfintheopinionoftheEyeCareProfessional,thepatient
isdeterminedtobeanacceptableExtendedWearcandidate,theEyeCareProfessionalis
encouragedtodetermineawearschedulebasedupontheresponseofthepatient.

Onceremoved,itisrecommendedthatthelensremainsoutoftheeyeforaperiodofrest
overnightorlonger.TheEyeCareProfessionalshouldexaminethepatientduringtheearly
stagesofExtendedWear.


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CONTRAINDICATIONS

DONOTUSEACUVUE®BrandContactLenseswhenanyofthefollowingconditionsexist,
whenprescribingforrefractiveametropia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eye).
• 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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lensesprescribedonafrequentreplacementwearschedule.
• Anyactivecornealinfection(bacterial,fungal,protozoalorviral).
• Ifeyesbecomeredorirritated.

ForTHERAPEUTICUSE,theEyeCareProfessionalmayprescribeACUVUEOASYS®Brand
ContactLenseswithHYDRACLEAR®PLUS,toaidinthehealingprocessofcertainocular
conditions,whichmayincludethosecitedabove.

WARNINGS

(DailyWear=lessthan24hours,whileawake;ExtendedWear=greaterthan24hours,
includingwhileasleep).
Proper useandcareofcontactlenses and lenscareproducts,including lenscases,are
essentialforsafeuse.Problemsfromwearingcontactlensesorusinglenscareproducts
couldresultinseriousinjurytotheeye.
Patientsshouldbeadvisedofthefollowingwarningspertainingtocontactlenswear:
• ACUVUE®BrandDailyDisposableContactLensesareprescribedfordailywearandare
forsingleuse.Studieshaveshownthatdailydisposablesoftcontactlenswearreduces
theriskofsomecomplicationsincludingdiscomfortandinflammationthatare
associatedwithlenscareandhandling,andreusecanputyouatgreaterriskofthese
problems.
• 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.†
• Eyeproblems,includingcornealulcers,candeveloprapidlyandleadtolossofvision.
• Studieshaveshownthattheriskofulcerativekeratitisisgreaterforextendedwear
contactlensusersthanfordailywearusers.
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• Whendailywearusersweartheirlensesovernight(outsidetheapprovedindication),
theriskofulcerativekeratitisis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.
• Studieshaveshownthattheriskofulcerativekeratitisamongcontactlensuserswho
smokeisgreaterthanamongnonͲsmokers.
• Donotexposecontactlensestowaterduringswimming,otherwatersportsorbathing
asthiscouldincreasetheriskofseriouseyeinfectionfrommicroorganismswhichcould
leadtovisionloss.Iflenseshavebeensubmersedinwater,thepatientshoulddiscard
andreplacethemwithanewpair.TheEyeCareProfessionalshouldbeconsultedfor
recommendationsregardingwearinglensesduringanyactivityinvolvingwater.

Ifpatientsexperienceeyediscomfort,excessivetearing,visionchanges,rednessoftheeye
orotherproblemsareexperienced,theyshouldbeinstructedtoimmediatelyremovetheir
lensesandthewearershouldpromptlycontacttheirEyeCareProfessional.Itis
recommendedthatcontactlenswearersshouldseetheirEyeCareProfessionalroutinely
asdirected.
†NewEnglandJournalofMedicine,September21,1989,321(12),pp.773Ͳ783

PRECAUTIONS

Whattodoifproblemsoccur

PLEASEADVISEYOURPATIENTTOREMOVECONTACTLENSESIMMEDIATELYANDSEEK
ADVICEFROMTHEIREYECAREPROFESSIONAL.

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transmissibility,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theeyeshouldbecarefullymonitored
bytheprescribingEyeCareProfessional.
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
• Duetothereductioninlighttransmittancewithcosmeticallytintedlensessomepatients
mayexperiencevisualsymptomswhilewearing1•DAYACUVUE®DEFINE®BrandContact
LenseswithLACREON®.Inaddition,somepatientsmayexperienceperipheralawareness
duetotheopaqueirispattern.
• Patients who wear the ACUVUE® Brand Contact Lenses to correct presbyopia using
monovisionormultifocalcorrection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lensforeachpatient.
• 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asterilesalinesolutionthatisrecommendedforinͲeyeuse.
• EyeCareProfessionalsshouldinstructthepatienttoremovethelensesimmediatelyif
theeyesbecomeredorirritated.
• Eye Care Professionals should carefully instruct patients about the following care
regimenandsafetyprecautions.

HandlingPrecautions
• BeforeleavingtheEyeCareProfessional'soffice,thepatientshouldbeabletoputon
andpromptlyremovelensesorshouldhavesomeoneelseavailablewhocandothisfor
them.
• DONOTuseifthesterileblisterpackageisopenedordamaged.
• 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.
• Donottouchcontactlenseswiththefingersorhandsifthehandsarenotfreeofforeign
materials,asmicroscopicscratchesofthe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 ACUVUE® Brand Contact
LensesandthoseprescribedbytheEyeCareProfessional.
• Alwayshandlelensescarefullyandavoiddroppingthem.
• Neverusetweezersorothertoolstoremovelensesfromthelenscontainer.Carefully
removethelensbyslidingitupthesideofthecontainer.
• Donottouchthelenswithfingernails.
• Close supervision is necessary for the Therapeutic use of all ACUVUE OASYS® Brand
Contact Lenses with HYDRACLEAR® PLUS. Ocular medications used during treatment
withabandagelensshouldbecloselymonitoredbytheEyeCareProfessional.Incertain
ocularconditions,onlytheEyeCareProfessionalwillinsertandremovethelenses.In
thesecases,patientsshouldbeinstructednottohandlethelensesthemselves.
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
LensWearingPrecautions

• Ifthelenssticks(stopsmoving)ontheeye,followtherecommendeddirectionsin"Care
foraStickingLens".Thelensshouldmovefreelyontheeyeforthecontinuedhealthof
theeye.IfnonͲmovementofthelenscontinues,thepatientshouldbeinstructedto
immediatelyconsulthisorherEyeCareProfessional.
• NeverwearlensesbeyondtheperiodrecommendedbytheEyeCareProfessional.
• Ifaerosolproducts,suchashairspray,areusedwhilewearinglenses,exercisecaution
andkeepeyescloseduntilthesprayhassettled.
• Avoidallharmfulorirritatingvapoursandfumeswhilewearinglenses.
• Never allow anyone else to wear your lenses. Sharing lenses greatly increases the
chancesofeyeinfections.
• Aftertherecommendedwearingschedule,alwaysdiscardlenseswornasprescribedby
theEyeCareProfessional.

SolutionPrecautions

• Differentsolutionscannotalwaysbeusedtogetherandnotallsolutionsaresafeforuse
withalllenses.Useonlyrecommendedsolutions.
• ThepatientshouldnotchangesolutionswithoutconsultingtheirEyeCareProfessional.
• Neverusesolutionsrecommendedforrigidgaspermeable(RGP)contactlenses.
• Alwaysusefresh,unexpiredlenscaresolutionsandlenses.
• Alwaysfollowdirectionsinthepackageinsertsfortheuseofcontactlenssolutions.
• Useonlyachemical(notheat)lenscaresystem.Useofaheat(thermal)caresystemcan
damageACUVUE®BrandContactLenses.
• Sterileunpreservedsolutions,whenused,shouldbediscardedafterthetimespecified
inthedirections.
• Donotusesalivaoranythingotherthantherecommendedsolutionsforlubricatingor
wettinglenses.
• Always keep the lenses completely immersed in the recommended storage solution
whenthe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)Lens"iflenssurfacedoesbecomedriedout.

LensCasePrecautions

Lens cases can be a source of bacterial growth and require proper use, cleaning and
replacementatregularintervalsasrecommendedbythelenscasemanufacturerorEyeCare
Professional.


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
OtherTopicstoDiscusswithPatients

• AlwayscontacttheEyeCareProfessionalbeforeusinganymedicinesoreyeͲdropsinthe
eyes.
• Certainmedications,suchasantihistamines,decongestants,diuretics,musclerelaxants,
tranquilizersandthoseformotionsicknessmaycausedrynessoftheeye,increasedlens
awarenessorblurredvision.Shouldsuchconditionsexist,properremedialmeasures
shouldbeprescribed..
• Oralcontraceptiveuserscoulddevelopvisualchangesorchangesinlenstolerancewhen
usingcontactlenses.Patientsshouldbecautionedaccordingly.
• Aswithanycontactlens,followͲupvisitsarenecessarytoassurethecontinuinghealth
ofthepatient'seyes.ThepatientshouldbeinstructedastoarecommendedfollowͲup
schedule.

WhoShouldKnowThatthePatientisWearingContactLenses?

• Informallofyourdoctors(HealthCareProfessional)aboutbeingacontactlenswearer.
• 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.

ADVERSEREACTIONS

The patient should be informed that the following problems may occur when wearing
ACUVUE®BrandContactLenses:

• Theeyemayburn,stingand/oritch.
• Theremaybelesscomfortthanwhenthe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 oedema,
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haloesaroundobjects,photophobia,or
symptomsofeyedrynessmayalsooccurifthelensesareworncontinuouslyorfortoo
longatime.




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
Thepatientshouldbeinstructedtoconductasimple3ͲpartselfͲexaminationatleastonce
aday.Theyshouldaskthemselves:
• Howdothelensesfeelonmyeyes?
• Howdomyeyeslook?
• HaveInoticedachangeinmyvision?

If the patient reports any problems, he or she should be instructed to IMMEDIATELY
REMOVETHELENS.Ifthediscomfortorproblemstops,thepatientshouldthenlookclosely
atthelens.Ifthelensisinanywaydamaged,thepatientSHOULDNOTputthelensbackon
theeye.Thepatientshoulddiscardthelensandapplyanewfreshlensontheeye.

Ifthelenshasdirt,aneyelash,orforeignbodyonit,ortheproblemstopsandthelens
appearsundamaged,heorsheshouldbeinstructedtodisposeofthelensandapplyanew
freshlens.Iftheproblemcontinues,thepatientSHOULDNOTputthelensbackontheeye
butIMMEDIATELYCONSULTHISORHEREYECAREPROFESSIONAL.

The patient should also be instructed NOT to use a new lens as selfͲtreatment for the
problem.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.Thepatientshouldbeinstructedtoseekimmediateprofessionalidentificationof
theproblemandprompttreatmenttoavoidseriouseyedamage.

Duringtherapeuticuseanadverseeffectmaybeduetotheoriginaldiseaseorinjuryormay
beduetotheeffects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injuredeye.Thepatientshouldbeinstructedtoavoidseriouseye
damagebycontactingtheEyeCareProfessionalIMMEDIATELYifthereisanincreasein
symptomswhilewearingthelens.

Lenscaredirections

When lenses are dispensed, the Eye Care Professional should provide the patient with
appropriate and adequate warnings and instructions in accordance with the individual
patient’slenstypeandwearingschedule.TheEyeCareProfessionalshouldrecommendan
appropriatecaresystemtailoredtothepatient’sindividualrequirements.

Failuretofollowthecorrectlenscareregimemayresultinseriousinjurytotheeye,as
describedinthesectionentitled–“Warnings”
Forcompleteinformationconcerningcontactlenshandling,care,cleaning,disinfectingand
storage,refertothePatientInstructionGuideforACUVUE®BrandContactLenses.
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
When ACUVUE® Brand Contact Lenses are recommended for frequent replacement, as
showninTable1,thelensesmustbecleanedanddisinfectedfollowingremovalbeforereͲ
use.Thelensesmaybedisinfectedusingachemicaldisinfectionsystemonly(e.g.multiͲ
purposeorhydrogenperoxidesystem).

TheEyeCareProfessionalshouldreviewwiththepatientlenscaredirections,includingbasic
informationonlenscasecleaningaswellasspecificinstructionsonthelenscareregimen
recommendedforthepatient.Sincesomelensmaterialscontainsilicone,asshowninTable
1,thewettabilitymaydifferwhendifferentlenscareproductsareused.

Careforasticking(nonͲmoving)lens

Ifthelenssticks(stopsmoving),thepatientshouldbeinstructedtoapplyafewdropsofa
recommendedlubricatingorrewettingsolutiondirectlytotheeyeandwaituntilthelens
beginstomovefreelyontheeyebeforeremovingit.IfnonͲmovementofthelenscontinues
afterafewminutes,thepatientshouldimmediatelyconsulttheEyeCareProfessional.

Careforadriedout(dehydrated)lens

IfanyACUVUE®Lensisofftheeyeforaprolongedperiod,itssurfacemaybecomedryand
graduallybecomenonͲwetting.Ifthisshouldoccur,discardthelensanduseanewone.
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CASUALTYDEPARTMENTWITHOUTDELAY.













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
REPORTINGOFADVERSEREACTIONS

All serious adverse experiences and adverse reactions observed in patients wearing
ACUVUE®BrandContactLensesorexperiencedwiththelensesshouldbereportedto:

Johnson&JohnsonMedicalLimited
PinewoodCampus
NineMileRide
Wokingham
RG403EW
UnitedKingdom
Tel:08000224222Fax:08007837029
EͲmail:ukcs@visgb.jnj.com

Additionalinformation

ForadditionalinformationconcerningACUVUE®BrandContactLensesandtoorderyour
freecopyofACUVUE®BrandContactLensesPatientInstructionGuides,pleasecontactthe
addressshownabove.

Manufacturedby:

Pleaserefertocartonforsiteofmanufacture

USA:
Johnson&JohnsonVisionCare,Inc.
7500CenturionParkway
Jacksonville
Florida,32256
USA
IRELAND:
Johnson&JohnsonVisionCare(Ireland)
TheNationalTechnologyPark
Limerick
Ireland

EUAuthorisedRepresentative:

Johnson&JohnsonMedicalLimited
PinewoodCampus
NineMileRide
Wokingham
RG403EW
UnitedKingdom
www.acuvue.com


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
Erläuterung:

Verpackungslösung: n Gepufferte Kochsalzlösung o Gepufferte Kochsalzlösung mit MethyletherͲCellulose p
GepufferteKochsalzlösungmitPovidon

Material:qLinsenmaterialenthältSilikonunderfülltdieKlasse1UVͲAbsorptionskriterienmiteinerTransmissibilität
vonwenigerals1%UVB(280Ͳ315nm)und10%UVAͲStrahlung(316Ͳ380nm).

AlletafilconAProdukteerfüllendieKlasse2UVͲAbsorptionskriterienmiteinerTransmissibilitätvonwenigerals5%
UVBund50%UVAͲStrahlung.























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
INHALT

ACUVUE® Kontaktlinsen sind einzeln in gepufferter Kochsalzlösung in sterilen Blistern
verpackt (Verpackungslösung: siehe Tabelle 1). NICHT VERWENDEN, wenn die sterile
Blisterverpackunggeöffnetoderbeschädigtwurde.

VERWENDUNGSZWECK

SphärischeACUVUE®Kontaktlinsen

FürTagestragen(TT)undverlängertesTragen(vT)gemäßTabelle1,zurKorrektureiner
Fehlsichtigkeit(KurzͲundWeitsichtigkeit)amgesundenAugebeiPersonenmitoderohne
Aphakie,füreinenAstigmatismusbis1,00D.

1•DAYACUVUE®DEFINE®withLACREON®sindauchgeeignet,umdasAussehenderAugen
zuverbessernoderzuverändern.

TorischeACUVUE®Kontaktlinsen

Für Tagestragen und verlängertes Tragen gemäß Tabelle 1, zur Korrektur einer
Fehlsichtigkeit(KurzͲundWeitsichtigkeit)amgesundenAugebeiPersonenmitoderohne
Aphakie,füreinenAstigmatismus.

MehrstärkenACUVUE®Kontaktlinsen

Für Tagestragen und verlängertes Tragen, wie in Tabelle 1 beschrieben, für die Korrektur
brechungsbedingt  fehlsichtiger Personen (Kurzsichtigkeit und Weitsichtigkeit) bestimmt, die
entwederalterssichtig,linsenlosodermitIntraokularlinsenausgestattetsindundgesundeAugen
miteinemAstigmatismusvonmaximal0,75Daufweisen.

Zusätzlich sind ACUVUE OASYS® Kontaktlinsen with HYDRACLEAR® PLUS auch als
VerbandlinsefürfolgendeakuteundchronischeSymptomeangezeigt:

x
ZumSchutzderCorneabeilidͲundcornealenAbnormitätenwieEntropium,Trichiasis,
tarsalenNarbenoderwiederkehrendencornealenErosionen.Zusätzlichsindsieauch
dortangezeigt,woWundnähte,okuläreFehlbildungenoderLähmungeneinenSchutz
derCorneavorBelastungenoderwiederholtenIrritationenerforderlichmachen.
x
ZurcornealenSchmerzlinderungwiebeiKeratopathiabullosa,epithelialerErosionund
Abrasion,KeratitisfilamentosaundnachKeratoplastik.
x
ZurNutzungalsBarrierewährenddesHeilungsprozessesbeiepithelialenDefektenwie
chronischen epithelialen Defekten, ulzerativer Keratitis, neurotropher Keratopathie,
neuroparalytischerKeratitisundVerätzungen.
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
x
ZurNachversorgungbeichirurgischenEingriffen,beideneneinVerbandlinsengebrauch
angezeigt
ist,
wie
nach
refraktiver
Chirurgie,
lamellierender
Keratoplastik,
HornhautlamellenundzusätzlichenaugenchirurgischenBegleitumständen.
x
ZurstrukturellenStabilisierungundzumSchutzbeiHuckepackͲSystemen,beidenendie
CorneaundangeschlosseneOberflächenzuirregulärgestaltetsindundkeineAnpassung
mit einer formstabilen, gasdurchlässigen Kontaktlinse ermöglichen. Die Kontaktlinse
kann zudem dazu beitragen, Reizungen und Abrasionen bei Profilunterschieden am
Übergang zwischen Transplantat und Empfängerhornhaut oder an Narbengewebe zu
lindern.
DieACUVUEOASYS®KontaktlinsenwithHYDRACLEAR®PLUSfürtherapeutischeZwecke
könnenfürdasTagestragenoderfürdasverlängerteTragenangepasstwerden.
AlleACUVUE®KontaktlinsensindmiteinemUVͲSchutzausgestattet,derdazubeitragen
kann,dieHornhautunddasInneredesAugesvorschädlicherUVͲStrahlungzuschützen.

WARNUNG: UVͲabsorbierende Kontaktlinsen sind KEIN Ersatz für UVͲabsorbierende
BrillenwieUVͲabsorbierendeSchutzbrillenoderSonnenbrillen,weilsiedasAugeundden
Augenbereichnichtvollständigabschirmen.SiesolltendaherweiterhinUVͲabsorbierende
Brillentragen.

Hinweis:EinelangfristigeUVͲExpositionderAugengehörtzudenRisikofaktorenfürGrauen
Star. Die Exposition ist von zahlreichen Faktoren abhängig. Zu diesen gehören
Umweltfaktoren(Höhe,Geografie,Bewölkung)sowiepersönlicheFaktoren(Umfangund
Art der Aktivitäten im Freien). Alle ACUVUE® Kontaktlinsen sind mit einem UVͲSchutz
ausgestattet,derdazubeiträgt,dieHornhautunddasInneredesAugesvorschädlicherUVͲ
Strahlungzuschützen.EswurdenjedochkeineklinischenStudiendurchgeführt,umden
Nachweiszuerbringen,dassdasTragenvonKontaktlinsenmitUVͲSchutzdasRisikovon
Grauem Star oder anderen Augenbeschwerden reduziert. Wenden Sie sich an Ihren
Kontaktlinsenanpasser,umausführlichereInformationenzuerhalten.

TRAGEMODUS

DerTragemodusundAustauschrhythmusmussdurchdenKontaktlinsenanpasserfestgelegt
werden.Kontaktlinsenträgerneigenmanchmaldazu,dieKontaktlinsenanfangszulangezu
tragen. Der Kontaktlinsenanpasser sollte dem Kontaktlinsenträger verdeutlichen, wie
wichtig die exakte Einhaltung des anfänglichen maximalen Tragemodus ist. Auch
regelmäßigeKontrollendurchdenKontaktlinsenanpassersindvongrößterBedeutung.



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
TagestragenͲKontaktlinsenfürdeneinmaligenGebrauch
Die ACUVUE® Kontaktlinsen sollten beim Tagestragen für den einmaligen Gebrauch
(wenigerals24StundenimWachzustand)gemäßTabelle1nureinmalgetragenundtäglich
nachdemAbnehmenentsorgtwerden.IndiesemFallistkeineReinigungoderDesinfektion
erforderlich.
1•DAY
ACUVUE®
TruEye®
Kontaktlinsen
sind
nicht
für
die
Nutzung
von
Kontaktlinsenpflegemitteln und Desinfektionssystemen entwickelt worden. Die Linsen
solltennachdemGebrauchentsorgtwerden.StartenSiejedeTrageperiodemiteinerneuen
Linse.
WiederverwendbareKontaktlinsenzumTagestragen
AlleACUVUE®VitaTMKontaktlinsenzumTagestragen(wenigerals24Stundenim
Wachzustand),wieinTabelle1beschrieben,müssenjedenMonatentsorgtund
ausgetauschtwerden.
AlleanderenwiederverwendbarenACUVUE®KontaktlinsenzumTagestragenmüssenalle
zweiWochenentsorgtundausgetauschtwerden.

Alle ACUVUE® Kontaktlinsen gemäß Tabelle 1 (Spaltenüberschrift Tagestragen –
Wiederverwendbar)müssennachjedemAbnehmenmiteinemchemischenPflegesystem
gereinigt,abgespültunddesinfiziertwerden.

VerlängertesTragen

ACUVUE®KontaktlinsenzumverlängertenTragen(längerals24Stunden,alsoauchüberNacht)
gemäßTabelle1könnenkontinuierlichbiszu7Tagen/6Nächtengetragenwerdenundmüssen
nach dem Abnehmen entsorgt werden. Eine Reinigung oder Desinfektion ist hierbei nicht
erforderlich.

Der Kontaktlinsenanpasser sollte zunächst im Rahmen des Tagestragens von
wiederverwendbaren Kontaktlinsen feststellen, ob das verlängerte Tragen für den
KontaktlinsenträgerinFragekommt.IstdiesderFall,solltederKontaktlinsenanpasserden
TragemodusindividuellaufdenKontaktlinsenträgerabstimmen.

NachdemAbnehmensollenmindestensüberNachtkeineneueKontaktlinsenaufgesetzt
werden. Der Kontaktlinsenanpasser sollte den Kontaktlinsenträger in der Anfangszeit
häufigerkontrollieren.



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
GEGENANZEIGEN

KEINE ACUVUE® Kontaktlinsen zur Korrektur einer Fehlsichtigkeit anpassen, wenn
mindestens eines der nachstehend genannten Symptome des Auges oder Augenlids
vorliegt.

• AkuteodersubakuteEntzündungoderInfektionderVorderkammerdesAuges.
• Alle Erkrankungen, Verletzungen oder Anomalien von Hornhaut, Bindehaut oder
Augenlidern.
• SchwereVerminderungderTränensekretion(trockeneAugen).
• HypästhesiederHornhaut(verminderteHornhautempfindlichkeit).
• JeglichesystemischeErkrankungmitAuswirkungenaufdasAuge,diedurchKontaktlinsen
verstärktwerdenkann.
• Allergische Reaktionen der Augenoberfläche oder Augenumgebung, die durch das
TragenvonKontaktlinsenoderdenGebrauchvonKontaktlinsenͲPflegemittelnausgelöst
oderverstärktwerden.
•AllergischeReaktionaufInhaltsstoffeinPflegelösungen,wieQuecksilberoder
Thiomersal.
•JeglicheaktivenHornhautentzündungen(BakterienͲ,PilzͲoderVireninfektion).
•WenndieAugenrotodergereiztsind.

ACUVUE
OASYS®
Kontaktlinsen
with
HYDRACLEAR®
PLUS
können
auch
zu
THERAPEUTISCHEN ZWECKEN angepasst werden, um den Heilungsprozess bestimmter
Symptomezuunterstützen(unteranderemdievorgenanntenSymptome).

WARNUNGEN

(TäglichesTragen=wenigerals24StundenimWachzustand;verlängertesTragen=länger
als24Stunden,alsoauchüberNacht).
Die richtige Anwendung und Pflege der Kontaktlinsen sowie der richtige Gebrauch der
Pflegeprodukte(u.a.dieReinigungdesAufbewahrungsbehälters)sindunerlässlichfürdie
sichereNutzungderKontaktlinsen. ProblemebeimTragen derKontaktlinsen oder beim
GebrauchderPflegeproduktekönnenzuschwerenSchädigungenamAugeführen.

DieKontaktlinsenträgersindüberdiefolgendenWarnungenhinsichtlichdesTragensvon
Kontaktlinsenzuinformieren:

• ACUVUE®EinͲTagesKontaktlinsensindfürdentäglichenundeinmaligenGebrauch
konzipiert.Studienhabengezeigt,dassweicheTageslinsendasRisikovoneinigen
KomplikationenwieDiskomfortundEntzündungen,diemitderLinsenpflegeundder
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
Handhabungverbundensind,reduzieren.EinWiederverwendenkanneinerhöhtes
RisikofürdieseProblemenachsichziehen.
• ProblemebeimTragenderKontaktlinsenoderbeimGebrauchderPflegeprodukte
können zu schweren Schädigungen am Auge führen. Die Kontaktlinsenträger sind
daraufhinzuweisen,dassdierichtigeAnwendungundPflegederKontaktlinsensowie
der
richtige
Gebrauch
der
Pflegeprodukte
(u.
a.
die
Reinigung
des
Aufbewahrungsbehälters) unerlässlich für die sichere Nutzung der Kontaktlinsen
sind.†
• Augenbeschwerden (z. B. Hornhautgeschwüre) können sich rasch entwickeln und
zumSehverlustführen.
• In Studien wurde festgestellt, dass das Risiko einer ulzerativen Keratitis bei
KontaktlinsenträgernimvTͲModushöheristalsimTTͲModus.
• WennTTͲTrägerdieKontaktlinsenüberNachtaufdemAugebelassen(entgegendem
freigegebenen Verwendungszweck dieser Linsen), ist das Risiko einer ulzerativen
KeratitishöheralsbeiTTͲTrägern,diedieKontaktlinsenbestimmungsgemäßnuram
Tagtragen.
• DasGesamtrisikoeinerulzerativenKeratitiskanndurchsorgfältigeBeachtungder
Vorschriften für die Pflege der Kontaktlinsen und des Aufbewahrungsbehälters
vermindertwerden.
• In Studien wurde festgestellt, dass das Risiko einer ulzerativen Keratitis bei
Kontaktlinsenträgern,diezugleichRauchersind,höheristalsbeiNichtrauchern.
• KontaktlinsensolltenbeimSchwimmen,BadenoderbeiWassersportartennichtmit
demWasserinBerührungkommen,dadiesdasRisikovonschweren
AugeninfektionendurchMikroorganismen,diezuSehverlustführenkönnen,erhöht.
WennLinsenmitWasserinBerührunggekommensind,solltendieseentsorgtund
miteinemneuenPaarersetztwerden.DerKontaktlinsenspezialistsolltefür
EmpfehlungenfürdasTragenvonKontaktlinsenbeiWasseraktivitätenkonsultiert
werden.
WennReizungenoderRötungendesAuges,ÄnderungendesSehvermögensoder
andereProblemeauftreten,solltendieKontaktlinsenträgerdieKontaktlinsensofort
vomAugenehmenundsichanihrenKontaktlinsenanpasserwenden.Der
KontaktlinsenträgersolldenKontaktlinsenanpasserinregelmäßigenAbständenzur
Kontrolleaufsuchen.
†NewEnglandJournalofMedicine,September21,1989,321(12),pp.773Ͳ783





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
VORSICHTSMAßNAHMEN

WEISENSIEDENKONTAKTLINSENTRÄGERAN,DIEKONTAKTLINSENBEIAUFTRETENDEN
PROBLEMENSOFORTZUENTFERNENUNDSICHANDENKONTAKTLINSENANPASSERZU
WENDEN.

BesondereVorsichtsmaßnahmenfürKontaktlinsenanpasser

Aufgrund der geringen Anzahl von Patienten, die an klinischen KontaktlinsenͲStudien
teilnehmen, wurden der Aufbau und die materialbedingten Linseneigenschaften, sowie
sämtliche Stärkenparameter nicht in ausreichender Zahl bewertet. Daher sollte der
Kontaktlinsenanpasser bei der Auswahl des Aufbaus und der Eigenschaften der
Kontaktlinsen alle Linseneigenschaften berücksichtigen, die einen Einfluss auf die
LeistungsfähigkeitderLinsenunddieAugengesundheithabenkönnen.Dazugehörendie
Sauerstoffdurchlässigkeit,dieBenetzbarkeit,zentraleundperiphereLinsendickesowieder
DurchmesserderoptischenZone.

Der potentielle Einfluss dieser Faktoren auf die Augengesundheit des Patienten muss
sorgfältiggegendieNotwendigkeitderKorrektureinerFehlsichtigkeitabgewogenwerden.

Daher müssen Augengesundheit und die Leistungsfähigkeit der Linsen durch den
Kontaktlinsenanpassersorgfältigüberwachtwerden.

• Durch die reduzierte Lichtdurchlässigkeit bei Kontaktlinsen mit Handhabungstönung
können beim Tragen von 1•DAY ACUVUE® DEFINE® mit LACREON® bei manchen
Personen visuelle Symptome auftreten. Zudem können manche Kontaktlinsenträger
aufgrunddesopakenIrismustersdieFarbederKontaktlinsewahrnehmen.
• Kontaktlinsenträger,dieACUVUE®KontaktlinsentragenundIhreAlterssichtigkeitmittels
monovisionodermultifocalkorrigieren,erreicheneventuellwederfürdieNähenochfür
dieFernedieoptimaleSehqualität.DieAnforderungenandasSehensindindividuell
verschieden und müssen bei der Auswahl der optimalen Linsen für jeden Träger
berücksichtigtwerden.
• Fluorescein, ein gelber Farbstoff, darf nicht verwendet werden, solange sich die
Kontaktlinsen auf dem Auge befinden. Die Kontaktlinsen können diesen Farbstoff
aufnehmenundsichverfärben.WennsichFluoresceinaufdenAugenbefindet,sinddie
AugenmiteinerfürdieVerwendungamAugezugelassenensterilenKochsalzlösungzu
spülen.
• Kontaktlinsenanpasser sollten den Kontaktlinsenträger anweisen, die Linsen sofort
abzunehmen,wenndieAugenrotodergereiztwerden.
• Kontaktlinsenanpasser
müssen
Kontaktlinsenträger
sorgfältig
über
folgende
PflegeanweisungenundSicherheitsmaßnahmeninformieren.
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
VorsichtsmaßnahmenfürdieVerwendung

• BevorSieIhrenKontaktlinsenanpasserverlassen,solltenSieentwederselbstinderLage
sein,dieKontaktlinsenaufzusetzenundabzunehmenoderjemandeninderNähehaben,
derdasfürSietunkann.
• NICHT VERWENDEN, wenn die sterile Blisterverpackung geöffnet oder beschädigt
wurde.
• HändevordemAnfassenderLinsenstetswaschenundspülen.Kosmetika,Lotionen,
Cremes, Deodorants, Sprays oder Seife dürfen nicht in die Augen oder auf die
Kontaktlinsengelangen.DieKontaktlinsenambestenvordemAuftragenvonMakeͲup
aufsetzen.
• BerührenSieKontaktlinsennichtmirdenFingernoderHänden,wenndieHändenicht
freivonFremdkörpernsind,dasonstmikroskopischeKratzerandenLinsenentstehen
könnten,dieeinverzerrtesSehenund/oderVerletzungenamAugehervorrufenkönnten.
• BefolgenSiesorgfältigdieHandhabungsanweisungenzumAufsetzenundAbnehmen,zur
Reinigung,Desinfektion,AufbewahrungundTrageempfehlung,dieindenHandhabungsͲ
ratgebern für ACUVUE® Kontaktlinsen beschrieben sind, die Sie von Ihrem
Kontaktlinsenanpasser für die angepassten Kontaktlinsen ausgehändigt bekommen
sollten.
• BehandelnSieKontaktlinsenstetssorgfältigundlassenSiesienichtfallen.
• VerwendenSieniemalsPinzettenoderandereWerkzeuge,umIhreKontaktlinsenaus
dem Kontaktlinsenbehälterzuentfernen. Entnehmen Sie dieKontaktlinse, indemSie
diesevorsichtigseitlichausdemBehälterherausschieben.
• BerührenSiedieKontaktlinsennichtmitdenFingernägeln.
• Die
therapeutische
Verwendung
aller
ACUVUE
OASYS®
Kontaktlinsen
with
HYDRACLEAR®PLUSmussstrengüberwachtwerden.EinemedikamentöseBehandlung
des
Auges
während
der
Behandlung
mit
einer
Verbandlinse
muss
vom
Kontaktlinsenanpasserstrengüberwachtwerden.BeimanchenSymptomendarfnurder
KontaktlinsenanpasserdieLinsenaufsetzenundabnehmen.IndiesenFällenmüssendie
Patientenangewiesenwerden,dieKontaktlinsennichtselbstzuverwenden.

VorsichtsmaßnahmenfürdasTragenvonKontaktlinsen

• WenndieKontaktlinsezufestaufdemAugehaftet,sichalsonichtmehrbewegt,sollten
unbedingtdieEmpfehlungenzur„VorgehensweisebeieinerfestsitzendenKontaktlinse”
beachtet werden. Die Kontaktlinse muss sich auf dem Auge frei bewegen, um die
Augengesundheitzuerhalten.WenndieKontaktlinseweiterhinnichtfreibeweglichist,
solltederKontaktlinsenträgerunverzüglichdenKontaktlinsenanpasseraufsuchen.
• Kontaktlinsen nie über einen längeren, als vom Kontaktlinsenanpasser, empfohlenen
Zeitraumtragen.
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
• Wenn während des Tragens von Linsen Aerosolprodukte wie Haarspray verwendet
werden,mussvorsichtigvorgegangenwerdenunddieAugengeschlossenbleiben,bis
sichdasSprayverflüchtigthat.
• AlleschädlichenoderreizendenDämpfeoderRauchmüssenwährenddesTragensvon
Kontaktlinsenvermiedenwerden.
• Lassen Sie niemals andere Personen Ihre Kontaktlinsen tragen.  Der Austausch von
Kontaktlinsen zwischen verschiedenen Personen führt zu einem erhöhten Risiko von
Augeninfektionen.
• Entsorgen Sie Kontaktlinsen nach dem empfohlenen Tragemodus stets gemäß den
EmpfehlungendesKontaktlinsenanpassers.

VorsichtsmaßnahmenfürPflegemittel

• Verschiedene KontaktlinsenͲPflegemittel können nicht immer zusammen verwendet
werden, und nicht alle Mittel sind zum sicheren Gebrauch mit allen Kontaktlinsen
geeignet.VerwendenSienurempfohleneKontaktlinsenͲPflegemittel.
• Wechseln Sie nie Ihre Pflegemittelmarke ohne vorherige Konsultation Ihres
Kontaktlinsenspezialisten.
• VerwendenSieniePflegemittel,diefürharteKontaktlinsen(formstabileKontaktlinsen)
empfohlenwerden.
• Verwenden Sie stets frische KontaktlinsenͲPflegemittel und Kontaktlinsen, die das
Verfallsdatumnichtüberschrittenhaben.
• BefolgenSiebeimGebrauchvonKontaktlinsenͲPflegemittelnstetsdieAnweisungender
Packungsbeilage.
• Verwenden
Sie
ausschließlich
chemische
KontaktlinsenͲPflegesysteme
(keine
SterilisationdurchHitze).DieVerwendungeinesPflegesystems,dasWärmeverwendet
(thermischeDesinfektion)kannACUVUE®Kontaktlinsenbeschädigen.
• Sterile, nicht konservierte Pflegemittel müssen nach Gebrauch entsprechend dem
Zeitraumentsorgtwerden,derindenAnweisungenangegebenist.
• Verwenden Sie keinesfalls Spucke oder andere als die empfohlenen Mittel, um die
Kontaktlinsenzubenetzen.
• DieKontaktlinsenmüssenstetsvollständigvonderempfohlenenAufbewahrungslösung
bedecktsein,wennsienichtgetragenwerden(Aufbewahrung).EinelängereAustrocknung
reduziertdieBenetzbarkeitderKontaktlinsenoberfläche.BefolgenSiedieAnweisungenzur
Pflege der Kontaktlinsen in „Vorgehensweise bei einer ausgetrockneten (dehydrierten)
Kontaktlinse“,wenndieLinsenoberflächeausgetrocknetist.

VorsichtsmaßnahmenfürdenAufbewahrungsbehälter

Aufbewahrungsbehälter für Kontaktlinsen können Bakterienwachstum verursachen und
erfordern korrekte Verwendung, Reinigung und Austausch in regelmäßigen Abständen,
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
gemäß den Empfehlungen des Herstellers des Aufbewahrungsbehälters oder des
Kontaktlinsenanpassers.

AndereThemenzurDiskussionmitKontaktlinsenträgern

• WendenSiesichstetsandenAugenarzt,bevorSiedieAugenmedikamentösbehandeln
oderAugentropfenbenutzen.
• Bestimmte Medikamente, beispielsweise Antihistamine, Dekongestiva, Diuretika,
Muskelrelaxanzien, Tranquilizer und Mittel gegen Reisekrankheit, können eine
AustrocknungderAugen,einverstärktesFremdkörpergefühlundverschwommenesSehen
zurFolgehaben.IndiesenFällensindgeeigneteGegenmaßnahmenzuergreifen.
• BeiKontaktlinsenträgerinnen,dieeinEmpfängnisverhütungsmitteleinnehmen,können
Sehqualitätsschwankungen auftreten und/oder die Verträglichkeit der Kontaktlinsen
verändern.Patientenmüssendaraufhingewiesenwerden.
• Wie bei allen Kontaktlinsen sind regelmäßige Kontrollen notwendig, um die
Augengesundheit des Patienten sicherzustellen. Der Patient muss über einen
empfohlenenNachsorgeplaninformiertwerden.

Wersolltewissen,dassderPatientKontaktlinsenträgt?

• InformierenSiealleIhreÄrztedarüber,dassSieKontaktlinsentragen.
• InformierenSieIhrenArbeitgeberinjedemFalldarüber,dassSieKontaktlinsentragen.
BeibestimmtenTätigkeitenistdasTrageneinerSchutzbrillevorgeschriebenbzw.das
TragenvonKontaktlinsenuntersagt.

NEBENWIRKUNGEN

DerPatientistzuinformieren,dassbeimTragenvonACUVUE®Kontaktlinsendiefolgenden
Problemeauftretenkönnen:

• DasAugekannbrennen,stechenund/oderjucken.
• DasAugekanngereizterseinalsbeimerstenAufsetzenderKontaktlinsen.
• Eskannsichsoanfühlen,alsobSieetwasimAugehätten(Fremdkörper,Kratzer).
• Unter Umständen können periphere Infiltrate, periphere Hornhautgeschwüre und
ErosionderHornhautzuvorübergehendenBeeinträchtigungenführen.Eskönnenauch
weitere physiologische Veränderungen auftreten, beispielsweise lokale oder
generalisierteÖdeme,SymptomevontrockenenAugen,NeubildungvonGefäßeninder
Hornhaut, Hornhautverfärbungen, Gefäßinjektionen, Anomalien der Lidbindehaut,
Entzündung der Regenbogenhaut oder Bindehautentzündung, die bei geringer
Ausprägungklinischakzeptabelsind.
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
• StarkerTränenfluss,eineungewöhnlicheSekretbildungodereineRötungderAugenkönnen
ebenfallsauftreten.
• Verminderte
Sehschärfe,
verschwommenes
Sehen,
Wahrnehmungsstörungen,
Farbsäume um Objekte und Personen, Photophobie oder trockene Augen können
ebenfalls auftreten, wenn die Kontaktlinsen kontinuierlich oder zu lange getragen
werden.
DerPatientsollteangewiesenwerden,mindestenseinmaltäglicheinen3ͲPunkteͲSelbsttest
durchzuführen. ErSolltesichfolgendeFragenstellen:

• WiefühlensichdieKontaktlinsenaufmeinenAugenan?
• WiesehenmeineAugenaus?
• HabeicheineÄnderungderSehqualitätfestgestellt?

BerichtetderKontaktlinsenträgerübereinesderProbleme,sollteerangewiesenwerden,
DIELINSESOFORTABZUNEHMEN.VerschwindendieBeschwerdenoderdasProblem,sollte
der Kontaktlinsenträger sich die Kontaktlinse genau ansehen. Wenn die Kontaktlinse in
irgendeinerArtbeschädigtist,sollderKontaktlinsenträgerdieseNICHTwiederaufsetzen.
DerKontaktlinsenträgersolltedieLinseentsorgenundeineneueLinseaufsetzen.

BefindetsichSchmutz,eineWimperodereinFremdkörperaufderKontaktlinseundein
FremdköpergefühlverschwindetnachdemAbnehmenderKontaktlinsevomAuge,sollte
der Kontaktlinsenträger die Kontaktlinse auch dann entsorgen, wenn sie unbeschädigt
scheint.InderFolge,kanndanneineneue,frischeKontaktlinseaufgesetztwerden.Besteht
dasProblemnachdemAbsetzenderKontaktlinseweiterhin,sollderKontaktlinsenträger
KEINE neue  Kontaktlinse  mehr aufsetzen, sondern UNVERZÜGLICH DEN KONTAKTͲ
LINSENANPASSERAUFSUCHEN.

DerKontaktlinsenträgersollteauchdazuangewiesenwerden,KEINEneueKontaktlinseals
Selbstbehandlung des Problems zu verwenden. Der Kontaktlinsenträger soll darüber
informiert werden, dass bei Auftreten eines der oben genannten Symptome ernsthafte
BeschwerdenwieeineInfektion,einHornhautgeschwür,NeubildungvonGefäßenodereine
Entzündung der Regenbogenhaut vorliegen können. Der Kontaktlinsenträger soll
angewiesenwerden,dasProblemsofortmedizinischuntersuchenundbehandelnzulassen,
umeineernsthafteSchädigungderAugenzuvermeiden.

BeitherapeutischemEinsatzkanneineNebenwirkungdurchdieursprünglicheKrankheit
oder Verletzung oder durch das Tragen von Kontaktlinsen auftreten. Es besteht die
Möglichkeit der Verschlimmerung der bestehenden Krankheit/Beschwerden, wenn eine
weicheKontaktlinsezutherapeutischenZweckenverwendetwird,umeinverletztesAuge,
beidembereitsSymptomevorliegen,zubehandeln.DerPatientsollteangewiesenwerden,
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
denKontaktlinsenanpasserSOFORTaufzusuchen,wennsichdieSymptomebeimTragender
Linsenverstärken,umeineernsthafteSchädigungderAugenzuverhindern.

AnweisungenzurPflegederKontaktlinsen

BeiderAnpassungvonLinsensolltederKontaktlinsenanpasserdemKontaktlinsenträger
geeignete, adäquate Warnungen und Anweisungen geben, die zum individuellen
Kontaktlinsentyp
und
Tragemodus
des
Kontaktlinsenträgers
passen.
Der
Kontaktlinsenanpasser sollte ein geeignetes Pflegesystem empfehlen, das auf die
individuellenAnforderungendesKontaktlinsenträgersabgestimmtist.

Eine Nichteinhaltung der Anweisungen zur korrekten Pflege von Kontaktlinsen kann zu
ernsthaftenAugenschädigungenführen,wieimAbschnitt„Warnungen“beschrieben.

Vollständige Informationen zur Verwendung, Pflege, Reinigung, Desinfektion und
Aufbewahrung von Kontaktlinsen finden Sie in der Ratgeberbroschüre für ACUVUE®
Kontaktlinsen.

WennACUVUE®KontaktlinsenzurWiederverwendunggemäßTabelle1empfohlenwerden,
muss die Linse nach dem Abnehmen und vor dem Aufsetzen gereinigt und desinfiziert
werden.DieKontaktlinsendürfenausschließlichmiteinemchemischenSystemdesinfiziert
werden(z.B.MehrzweckͲoderWasserstoffperoxidͲSystem).

DerKontaktlinsenanpassersolltemitdemKontaktlinsenträgerdieAnweisungenzurPflege
der Kontaktlinsen (allgemeine Informationen, Reinigung der Kontaktlinsen) sowie die
individuellfürdiesenKontaktlinsenträgerfestgelegtenPflegeanweisungenbesprechen.Da
dasMaterialmancherKontaktlinsenSilikonenthält,wieinTabelle1dargestellt,kanndie
Benetzbarkeit variieren, wenn unterschiedliche KontaktlinsenͲPflegemittel verwendet
werden.

Vorgehensweisebeieinerfestsitzenden(nichtbeweglichen)Kontaktlinse

Wenn die Kontaktlinse fest am Auge haftet, sich also nicht mehr bewegt, sollte der
Kontaktlinsenträger
einige
Tropfen
einer
empfohlenen
BenetzungsͲ
oder
NachbenetzungslösungdirektaufdasAugegebenunddannabwarten,bisdieKontaktlinse
wieder frei auf dem Auge beweglich ist. Erst danach soll die Kontaktlinse vom Auge
genommenwerden.WenndieKontaktlinseauchnacheinigenMinutennochnichtwieder
freibeweglichist,solltederKontaktlinsenträgerunverzüglichdenKontaktlinsenanpasser
aufsuchen.


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
Vorgehensweisebeieinerausgetrockneten(dehydrierten)Kontaktlinse

WenneineACUVUE®KontaktlinsenfüreinenlängerenZeitraumvomAugeabgenommen
wird,kanndieOberflächeaustrocknenundnachundnachihreBenetzbarkeitverlieren.
DieKontaktlinseistindiesemFallzuentsorgenunddurcheineneueKontaktlinsezu
ersetzen.
NOTFÄLLE
DerKontaktlinsenträgeristdarüberzuinformieren,dassbeimEindringenvonChemikalien
jeglicher Art (Haushaltsreiniger, FlüssigͲGartendünger, Schädlingsbekämpfungsmittel,
Laborchemikalienusw.)indasAugewiefolgtvorzugehenist:DIEAUGENSOFORTMITVIEL
WASSER
SPÜLEN
UND
UNVERZÜGLICH
EINEN
AUGENARZT
ODER
DIE
AMBULANZ/NOTAUFNAHMEEINERKLINIKAUFSUCHEN.

MELDUNGVONNEBENWIRKUNGEN

AlleFälleerheblicherNebenwirkungenundUnverträglichkeiten,diebeimTragenoderim
ZusammenhangmitdenACUVUE®Kontaktlinsenbeobachtetwerden,sindbeifolgender
Stellezumelden:


Germany
Johnson&JohnsonMedicalGmbH
RobertͲKochͲStraße1,22851Norderstedt,Tel.:0800/1002590,Fax:01803/000311

Austria
Johnson&JohnsonMedicalProducts
Gunoldstr.16,1190Wien,Tel.:01/36025Ͳ235,Fax:01/36025Ͳ516


Switzerland
Johnson&JohnsonAG
Gubelstr.34,6300Zug,Tel.:0800/563992,Fax:0800/820082






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
WeitereInformationen

Um weitere Informationen zu ACUVUE® Kontaktlinsen zu erhalten oder Ihre kostenlose
RatgeberbroschürezuACUVUE®Kontaktlinsenzubestellen,wendenSiesichbitteunterder
obenaufgeführtenAdresse.

Hersteller:

HerstellungsortsieheVerpackung

USA:
Johnson&JohnsonVisionCare,Inc.
7500CenturionParkway
Jacksonville
Florida,32256
USA
IRELAND:
Johnson&JohnsonVisionCare(Ireland)
TheNationalTechnologyPark
Limerick
Ireland

BevollmächtigterinderEU:
Johnson&JohnsonMedicalLimited
PinewoodCampus
NineMileRide
Wokingham
RG403EW
UnitedKingdom
www.acuvue.com












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
INHOUD

ACUVUE® contactlenzen worden geleverd in afzonderlijke steriele blisterverpakkingen,
waarbij de lens is ingelegd in een gebufferde zoutoplossing (zie tabel 1 bij
Verpakkingsoplossing).NIETGEBRUIKENalsdesterieleverpakkinggeopendofbeschadigd
is.

GEBRUIKSBESTEMMING

ACUVUE®sferischecontactlenzen

Dezezijngeschiktvoordagelijksgebruikoflangduriggebruik,zoalsaangegevenintabel1,
voordeoptischecorrectievanrefractieveametropie(myopieenhyperopie)bijpersonen
metenzondernatuurlijkelens(afakie)enverdergezondeogen,meteenastigmatismevan
1,00Dofminder.

1•DAYACUVUE®DEFINE®BrandContactLenseswithLACREON®zijnookbedoeldomhet
oogteverfraaienofteveranderen.


ACUVUE®BrandContactLensesforAstigmatism

Dezezijngeschiktvoordagelijksgebruikoflangduriggebruik,zoalsaangegevenintabel1,
voordeoptischecorrectievanrefractieveametropie(myopieenhyperopie)bijpersonen
metenzondernatuurlijkelens(afakie)enverdergezondeogen,meteenastigmatisme.

ACUVUE®BrandContactLensesforPresbyopia

Dezezijngeschiktvoordagelijksgebruikoflangduriggebruik,zoalsaangegevenintabel1,
voordeoptischecorrectievanrefractieveametropie(myopieenhyperopie)bijpersonen
metpresbyopie,metenzondernatuurlijkelens(afakie)enverdergezondeogen,meteen
astigmatismevan0,75Dofminder.

Daarnaast kunnen ACUVUE OASYS® contactlenzen met HYDRACLEAR® PLUS worden
voorgeschrevenvoortherapeutischgebruikalsbandagelensingevalvandevolgendeacute
enchronischeoogaandoeningen:

x
Voorbeschermingvanhethoornvliesbijaandoeningenvanhetooglidenhethoornvlies,
zoals entropion, trichiasis, tarsale littekens en recidiverende hoornvlieserosie.
Bovendienkunnendezecontactlenzenwordenvoorgeschreventerbeschermingingeval
vanhechtingenofvervorming,aantastingofverlammingvandeoogstructuuromhet
hoornvliestebeschermentegenblootstellingofherhaaldeirritatie.

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
x
Voor verlichting van pijn aan het hoornvlies, bijvoorbeeld in geval van bulleuze
keratopathie,epithelialeerosieenabrasie,filamentairekeratitis,ennakeratoplastiek.
x
Voorgebruikalseenbarrièretijdenshetgenezingsprocesvanepithelialeaandoeningen,
zoals
chronische
epitheliale
aandoeningen,
corneale
ulcer,
neurotrofe
en
neuroparalytischekeratitis,enchemischebrandwonden.
x
Voor gebruik na operaties wanneer het gebruik van een bandagelens wordt
voorgeschreven, zoals postͲrefractieve chirurgie, lamellaire transplantaties, corneale
flappenenandereoogchirurgischeomstandigheden.
x
VoorstructurelestabiliteitenbeschermingbijhetpiggyͲbacklenssysteemdatwordt
toegepastwanneerhethoornvliesenaangrenzendeoppervlakkenteonregelmatigzijn
omgangbarehardevormstabiele(RGP)lenzentekunnenaanmeten.Gebruikvandelens
voorkomt bovendien irritatie en pijnlijke ogen bij littekenweefsel of andere
onregelmatighedenophetoogoppervlak.
ACUVUEOASYS®contactlenzenmetHYDRACLEAR®PLUSdiewordenvoorgeschrevenvoor
therapeutischgebruik,kunnenwordengedragenopbasisvandagelijksgebruikof
langduriggebruik.
AlleACUVUE®contactlenzenzijnvoorzienvaneenUVͲfilteromdecorneatehelpenbijhet
beschermendeschadelijkegevolgenvanUVͲstraling.

WAARSCHUWING:UVͲabsorberendecontactlenzenzijnGEENvervangingvoorbeschermende
UVͲabsorberendebrillen,zoalseenUVͲabsorberendeskiͲofzonnebril,aangezienzehetoog
en het gebied eromheen niet volledigbedekken.U moet UVͲabsorberendebrillenblijven
dragenzoalsaangegeven.

Opmerking:langdurigeblootstellingaanUVͲstralingiseenvanderisicofactorenvoorhet
ontstaanvanstaar(cataract).Hetblootstellingsniveauisafhankelijkvaneenaantalfactoren,
zoalsomgevingsfactoren(hoogte,geografischelocatie,bewolking)enpersoonlijkefactoren
(soortenduurvanactiviteitenindebuitenlucht).AlleACUVUE®contactlenzenzijnvoorzien
vaneenUVͲfilterdatdecorneaenhetooghelptbeschermentegendeschadelijkegevolgen
van UVͲstraling. Tot dusverre zijn er echter geen klinische onderzoeken uitgevoerd die
aantonendathetdragenvancontactlenzenmetUVͲfilterhetrisicoophetontstaanvan
cataract of andere oogziekten vermindert. Raadpleeg voor meer informatie uw
contactlensspecialist.

DRAAGSCHEMA

HetdraagͲenvervangschemadienentewordenvastgestelddoordecontactlensspecialist.
Lensdragers zijn vooral in het begin geneigd de lenzen te lang te dragen. De
contactlensspecialist dient te wijzen op het belang van het volgen van het maximum
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draagschema voor de beginperiode. Daarnaast zijn regelmatige controles, zoals
voorgeschrevendoordecontactlensspecialist,buitengewoonbelangrijk.

Dagelijksgebruik(Eenmaliggebruik)
ACUVUE®contactlenzen,voorgeschrevenvoorDagelijksgebruikͲEenmaliggebruik(voor
minderdan24uurgebruik,niettijdenshetslapen)zoalsaangegevenintabel1,zijnbedoeld
als daglenzen voor eenmalig gebruik en moeten na het uitnemen worden weggegooid.
Desinfectieofreinigingvandelenzenisinditgevaloverbodig.
1.DAY ACUVUE® TruEye® Brand contactlenzen zijn niet ontwikkeld voor gebruik in
combinatiemetcontactlensreinigersofdesinfectiesystemen.Delenzendienenteworden
weggegooidnagebruik.Startelkedraagperiodemeteenfrissenieuwecontactlens.
DagelijksgebruikͲRegelmatigevervanging
Alle ACUVUE® Vita™ contactlenzen voor Dagelijks gebruik Ͳ Regelmatige vervanging (voor
minderdan24uurgebruik,niettijdenshetslapen)zoalsaangegevenintabel1,moetenelke
maanddoornieuwelenzenwordenvervangen.
AlleandersACUVUE®contactlenzenvoorDagelijksgebruikͲRegelmatigevervangingmoeten
elketweewekendoornieuwelenzenwordenvervangen.
AlleACUVUE®contactlenzendieintabel1onderdekopDagelijksgebruikͲRegelmatige
vervangingzijnvermeld,moetentelkensnahetuitnemenwordengereinigd,afgespoelden
gedesinfecteerd, waarbij uitsluitend een chemisch desinfectiesysteem mag worden
gebruikt.

Langduriggebruik

ACUVUE® contactlenzen voor Langdurig gebruik (voor minder dan 24 uur gebruik, ook
tijdenshetslapen)zoalsaangegevenintabel1,zijnbedoeldvooraaneengeslotengebruik
totmaximaal7dagen/6nachtenenmoetennahetuitnemenwordenweggegooid.Deze
gebruikswijzemaaktreinigenofdesinfecterenoverbodig.

Hetisraadzaamombijnieuwecontactlensdragerseersttebekijkenhoezeopeenschema
van Dagelijks gebruik Ͳ Regelmatige vervanging van contactlenzen reageren. Als de
contactlensspecialistvanmeningisdatdeklanteengeschiktekandidaatisvoorlangdurig
gebruik, wordt de specialist aangeraden om op basis van de respons van de klant een
draagschemaoptestellen.

Nahetuitnemenvandecontactlenzenwordtaanbevolenomdezegedurendedeperiode
vannachtrust oflangeruit hetoogte laten.Gedurende debeginperiodevanlangdurig
gebruikdientdecontactlensspecialistdedragerregelmatigteonderzoeken.
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
CONTRAͲINDICATIES

GEBRUIKGEENACUVUE®contactlenzenalséénvandevolgendesituatiesvantoepassingis
wanneerucontactlenzenvoorschrijftvoorcorrectievanrefractieveametropie.

• Acuteofsubacuteontstekingofinfectievandevoorsteoogkamer.
• Elke oogaandoening, beschadiging of afwijking van de cornea, de conjunctiva of de
oogleden.
• ErnstigelacrimalesecretieͲinsufficiëntie(drogeogen).
• Cornealehypesthesie(verminderdecornealegevoeligheid).
• Elkesystemischeaandoeningdieinvloedkanhebbenopdeogenofdoorhetdragenvan
contactlenzenkanverergeren.
• Allergische reacties van het oogoppervlak of aanhangsels, die kunnen worden
veroorzaakt of verergerd door het dragen van contactlenzen of het gebruik van
lensvloeistof.
•Allergievooreeningrediënt,zoalskwikofThimerosal,ineenoplossingdieisbedoeld
voorhetonderhoudvanlenzenvoorregelmatiggebruik.
•Eenactievecornealeinfectie(bacterie,schimmel,protozoönofvirus).
•Rodeofgeïrriteerdeogen.

Voor THERAPEUTISCH GEBRUIK kan de contactlensspecialist ACUVUE OASYS®
contactlenzenmetHYDRACLEAR®PLUSvoorschrijvenalshulpbijhetgenezingsprocesvan
bepaaldeoogaandoeningen,waartoebovengenoemdeaandoeningenkunnenbehoren.

WAARSCHUWINGEN

(Dagelijksgebruik=contactlensvoorminderdan24uurgebruik,terwijlwakker;Langdurig
gebruik=contactlensvoormeerdan24uurgebruik,ooktijdensslaap).Eenjuistenzorgvuldig
gebruikvancontactlenzenenlensverzorgingsproducten,metinbegripvanlenshouders,is
essentieelvooreenveiliggebruik.Problemenvoortkomenduithetdragenvancontactlenzen
ofhetgebruikvanproductenvoorhetonderhoudvancontactlenzenkunnenernstigeschade
aandeogenveroorzaken.

Dragersmoetenopdehoogtewordengebrachtvandevolgendewaarschuwingenmet
betrekkingtothetdragenvancontactlenzen:

• ACUVUE® daglenzen worden voorgeschreven voor het dragen overdag en voor
eenmaliggebruik.Studieshebbenaangetoonddathetdragenzachtedaglenzenhet
risicoverminderdophetkrijgenvansommigecomplicatieswaaronderdiscomforten
ontstekingendiezijngerelateerdaanhetverzorgenenhanterenvanlenzen,endat
hethergebruikvanlenzeneengroterrisicovormtophetkrijgenvanvoorgenoemde
problemen.
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• Problemen met contactlenzen of producten voor het onderhoud van contactlenzen
kunnen ernstige schade aan de ogen veroorzaken. Dragers moeten erop worden
gewezen dat het voor een veilig gebruik van contactlenzen en producten voor het
onderhouddaarvan,inclusieflenshouders,essentieelisomdezeproductenopdejuiste
maniertegebruikenenteverzorgen.†
• Oogproblemen,metinbegripvancornealeulcers,kunnenzichinraptempoontwikkelen
enkunnenleidentotverminderingvandevisus.
• UitonderzoeksresultatenblijktdathetrisicoopulceratievekeratitisgroterisbijEWͲ
dragersdanbijDWͲdragers.
• Bij DWͲdragers die hun lenzen 'snachts inhouden (en daarmee afwijken van de
goedgekeurdeindicatie),ishetrisicoopulceratievekeratitisgroterdanbijdragersdie
delenzenniet'snachtsinhouden.
• Het risicoop ulceratieve keratitis kan in hetalgemeen wordenverminderd door de
richtlijnenvoorhetverzorgenvandelenzennauwkeurigtevolgen,metinbegripvanhet
schoonmakenvandelenshouder.
• Uit onderzoeksresultaten blijkt dat het risico op ulceratieve keratitis groter is bij
dragersdierokendanbijnietͲrokers.
• Stel uw lenzen niet bloot aan contact met water tijdens zwemmen, andere
watersportenofhetnemenvaneenbadomdatdithetrisicovergrootophetkrijgen
vaneenserieuzeooginfectiedoormicroͲorganismenwatkanleidentothetverlies
vanhetgezichtsvermogen.Alslenzenincontactzijngeweestmetwater,dientde
gebruikerdezewegtegooienentevervangendooreennieuwpaarlenzen.Udient
uwoogzorgprofessionalteraadplegenvooradviezenoverhetgebruikvanlenzen
tijdensactiviteitenmetwater.

Alsdeogenvandedragerpijnlijkaanvoelen,meerdannormaaltanenofroodzijn,alshet
gezichtsvermogenvermindertofzichandereproblemenvoordoen,moetendecontactlenzen
onmiddellijkuitgenomenwordenenmoetdedragerdirectcontactopnemenmetzijnofhaar
contactlensspecialist.Contactlensdragerswordenaangeradenregelmatigeenbezoekbrengen
aanhuncontactlensspecialist,zoalsvoorgeschrevenisdoordecontactlensspecialist.

†Bron:NewEnglandJournalofMedicine,21September1989,321(12),pp.773Ͳ783

VOORZORGSMAATREGELEN

Wattedoenbijproblemen

ADVISEER DE DRAGER OM DE CONTACTLENZEN ONMIDDELLIJK UIT TE NEMEN EN
CONTACTOPTENEMENMETDECONTACTLENSSPECIALISTVOORADVIES.


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
Specialevoorzorgsmaatregelenvoordecontactlensspecialist

Vanwegehetkleineaantaldeelnemersaanklinischeonderzoekennaarlenzen,wordende
beschikbare refractie waarden, de ontwerpconfiguraties of de lensparameters van het
lensmateriaal niet geëvalueerd bij een statistisch significant aantal deelnemers.
Contactlensspecialisten moeten daarom bij de keuze van een passend lensontwerp en
lensparametersallekernmerkenvandelensinaanmerkingnemendievaninvloedkunnen
zijn op de lensprestaties en de oculaire gezondheid, inclusief zuurstoftransmissie,
bevochtigingsmogelijkheden,centraleenperiferedikteendiametervandeoptischezone.

Demogelijkeinvloedvandezefactorenopdeoculairegezondheidvandedragermoet
zorgvuldigwordenafgewogentegendenoodzaakvanrefractievecorrectie;omdiereden
moetdevoorschrijvendecontactlensspecialistdeoculairegezondheidvandedragerende
lensprestatiesvoorhetooghetnauwlettendindegatenhouden.

• Vanwegedeverminderdelichtdoorlatendheidvangekleurdelenzenkunnensommige
dragers van 1•DAYACUVUE® DEFINE® Brand Contact LenseswithLACREON® visuele
symptomen ervaren. Daarnaast kan bij sommige dragers door het ondoorzichtige
irispatrooneenbewustzijnvandeperiferievandelensoptreden.
• Voor dragers van de ACUVUE® contactlenzen voor correctie van presbyopie met
monovision of multifocal zal de optische correctie van verziendheid of bijziendheid
wellichtnietoptimaalzijn.Dewensentenaanzienvanscherpzichtzijnvoorelkedrager
andersendecontactlensspecialistmoetdaarmeerekeninghoudenbijdekeuzevaneen
passendtypelens.
• Fluoresceïne,eengelekleurstof,magnietwordengebruiktzolangdeFRQWDFWOHQ]HQQRJ
RSKHWRRJ]LWWHQDecontactlenzennemendezekleurstofopenverkleurendaardoor.Als
fluoresceïne in de ogen wordt gebruikt, moeten de ogen worden gespoeld met een
sterielezoutoplossingdieaanbevolenwordtvoorgebruikindeogen.
• Decontactlensspecialistmoetdedragernadrukkelijkwijzenopdenoodzaakdelenzen
bijrodeofgeïrriteerdeogenonmiddellijkteverwijderen.
• Decontactlensspecialistmoetdedragerookinformerenoverhetonderhoudschemaen
deveiligheidsvereisten.

Voorzorgsmaatregelenvoorgebruik

• Voordatdedragerdepraktijkvandecontactlensspecialistverlaat,moethijofzijinstaat
zijnomcontactlenzenintezettenengemakkelijkuittenemenofmoeteriemandanders
zijndiedecontactlenzenvoorhemofhaarkanuitnemen.
• NIETGEBRUIKENalsdesterieleverpakkinggeopendofbeschadigdis.
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• Wasenspoelaltijduwhandenvoordatucontactlenzenaanraakt.Zorgdatdeogenof
lenzennietincontactkomenmetcosmetica,lotions,zeep,crèmes,deodorantsofsprays.
DelenzenkunnenhetbestewordeningebrachtvoordatmakeͲupwordtgebruikt.
• Raakdecontactlenzennietmetdevingersofhandenaanalsdehandenniethelemaal
schoonzijn,omdatdaardoormicroscopischkleinekrassenopdelenzenkunnenontstaan
watzichtstoornissenen/ofbeschadigingenvanhetoogkanveroorzaken.
• Houd nauwgezet de instructies voor gebruik, inbrengen, uitnemen, schoonmaken,
desinfecteren, opbergen en dragen van de lenzen aan zoals beschreven in het
instructieboekjebijACUVUE®contactlenzenendelenzendiewordenvoorgeschreven
doordecontactlensspecialist.
• Behandeldelenzenmetzorgenlaatzenietvallen.
• Gebruikgeenpincetofanderhulpmiddelomdelenzenuitdelenshoudertehalen,tenziju
speciaal voor dat doel een hulpmiddel hebt gekregen. Haal de lens voorzichtig uit de
lenshouderdoordezelangsdewandvandelenshoudertelatenglijden.
• Raakdelensnietaanmetdevingernagels.
• AlleACUVUEOASYS®contactlenzenmetHYDRACLEAR®PLUSvoortherapeutischgebruik
moetenondersupervisiewordengebruikt.Gebruikvangeneesmiddelenvoordeogen
moettijdensbehandelingmet een bandagelens nauwgezet wordengevolgddoorde
contactlensspecialist. Bij sommige oogaandoeningen zal de contactlensspecialist de
lenzen inͲ en uitnemen. In deze gevallen moet de contactlensspecialist de drager
verzoekendecontactlenzennietzelfintebrengen.

Voorzorgsmaatregelenvoorhetdragen

• Alsdelensaanhetoogplakt(nietbeweegt),volgtuderichtlijnenin"Hetverzorgenvan
eenplakkende(nietͲbewegende)lens".Delensmoetvrijophetoogkunnenbewegen
om de gezondheid van de ogen op termijn te waarborgen. Als de contactlens blijft
plakken,moetdedragerhetadvieskrijgenonmiddellijkcontactoptenemenmetde
contactlensspecialist.
• Draagdelenzennietlangerdanaanbevolendoordecontactlensspecialist.
• Wanneeruspuitbussenmetbijvoorbeeldhaarlakgebruiktterwijlulenzeninhebt,moet
udatvoorzichtigdoenendeogengeslotenhoudentotdatallesprayisneergedaald.
• Vermijdschadelijkeofirriterendedampenenrookwanneerulenzendraagt.
• Laatanderemensenuwlenzennietdragen.Hetdelenvancontactlenzenvergrootde
kansopeenooginfectieenorm.
• .Gooinahetverstrijkenvanaanbevolendraagperiodedegedragenlenzenaltijdweg
volgensdeaanwijzingenvandecontactlensspecialist.


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
Voorzorgsmaatregelenvoordecontactlensvloeistof

x
Verschillendecontactlensvloeistoffenkunnennietaltijdsamenwordengebruikten
niet alle vloeistoffen zijn veilig voor alle lenzen. Gebruik alleen de aanbevolen
vloeistoffen.
x
Dedragermoetnietvancontactlensvloeistofveranderenzonderoverlegmetzijnof
haarcontactlensspecialist.
x
Gebruikgeenvloeistoffendiezijnaanbevolenvoorvormstabielelenzen(RGPͲlenzen).
x
Gebruikalleencontactlensvloeistofenlenzenwaarvandeuiterstehoudbaarheidsdatumnog
nietisverstreken.
x
Volgvoorinstructiesvoorgebruikvancontactlensvloeistoffenaltijddeaanwijzingen
indeproductbijlage.
x
Gebruikvoordelenzenuitsluitendeenchemischdesinfectiesysteem(geenhitte).Gebruikvan
een hittedesinfectiesysteem (thermale desinfectie) kan de ACUVUE® contactlenzen
beschadigen.
x
NietͲgeconserveerde,sterieleoplossingenmoetennagebruikopdeaangegeventijdworden
weggegooid.
x
Gebruik geen speeksel of iets anders dan de aanbevolen vloeistoffen voor het
bevochtigenvandecontactlenzen.
x
Houddelenzenvolledigondergedompeldindeaanbevolenopslagoplossingalsde
lenzennietwordengedragen.Langereperiodenvanblootstellingaanluchtverkleinen
dekansdathetoppervlakvandelensweervochtigwordt.Volgdeaanwijzingenin
"Hetverzorgenvaneenuitgedroogde(gedehydrateerde)lens"alshetoppervlakvan
delenzendroogwordt.


Voorzorgsmaatregelenvoordelenshouder

Contactlenshouders kunnen een bron van bacteriën zijn en moeten op de juiste wijze
wordengebruiktenregelmatigwordengereinigdenvervangenvolgensdeaanwijzingenvan
delenshouderfabrikantofdecontactlensspecialist.

Anderezakendiedragersmoetenweten

x
Vraag uw contactlensspecialist ook om advies voordat u geneesmiddelen of
oogdruppelsgebruiktinuwogen.
x
Sommige
medicijnen,
zoals
antihistaminica,
decongestiva,
diuretica,
spierverslappers, kalmerende middelen en medicijnen tegen zeeͲ, luchtͲ of
wagenziekte,kunnendrogeogenveroorzaken,delenzenmeervoelbaarmakenofhet
zicht vertroebelen. Als zich dergelijke omstandigheden voordoen, moeten er
passendemaatregelenwordengenomen.
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
x
Gebruikers van de anticonceptiepil kunnen bij het gebruik van contactlenzen
veranderingen ondervinden in hun zicht of in de mate waarin zij contactlenzen
kunnenverdragen.Dragersmoetenhieroverwordeningelicht.
x
Voorallecontactlenzengeldtdatvervolgbezoekenaandecontactlensspecialistde
gezondheidvanhetoogoptermijnwaarborgen.Decontactlensspecialistmoeteen
dedragerverzoekenzichtehoudenaangemaaktevervolgafspraken.

Wiemoetwetendatucontactlenzendraagt?

• Brengalluwartsen(behandelaars)opdehoogtevanhetfeitdatucontactlenzendraagt.
• Brengookdewerkgeveraltijdopdehoogtevanhetfeitdatucontactlenzendraagt.Bij
sommige werkzaamheden kan oogbescherming vereist zijn of is het dragen van
contactlenzenwellichtniettoegestaan.

BIJWERKINGEN

Dedragermoetopdehoogtewordengebrachtvanhetfeitdatdevolgendeproblemen
kunnenoptredentijdenshetdragenvanACUVUE®contactlenzen:

• Deogenkunnenbranden,prikkenofjeuken.
• Delenzenkunnennaverloopvantijdmindercomfortabelaanvoelen.
• Dedragerkanhetgevoelkrijgendaterietsinhetoogzit(stofje,krasje).
• Er kunnen tijdelijke verslechteringen ontstaan vanwege perifere infiltraten, perifere
cornealeulceratieencorneaͲerosie.Ookkunnenanderefysiologischeindicatiesworden
waargenomen,zoalslokaalofalgemeenoedeem,cornealeneovascularisatie,corneale
staining,vaatingroei,tarsaleafwijkingen,iritisenconjunctivitis.Sommigehiervanzijnin
beperktemateklinischaanvaardbaar.
• Deogenkunnenmeertranendannormaal,eenongebruikelijkeafscheidingvertonenof
deogenkunnenroodworden.
• Onscherp zicht, wazig zicht, halo’s of bogen rondom voorwerpen, fotofobie of
symptomenvandrogeogenkunnenzicheveneensvoordoenbijaaneengeslotenofte
langgebruikvandecontactlenzen.

Decontactlensspecialistmoetdedrageradviserendagelijkseensimpele,driedeligezelftest
uittevoeren.Hierbijbeantwoordtdedragerdevolgendedrievragen:
• Hoevoelendelenzenaan?
• Hoezienmijnogeneruit?
• Merkikeenverschilinmijngezichtsvermogen?

Alsdedragereenprobleemervaart,moethijofzijdeCONTACTLENZENONMIDDELLIJK
UITNEMEN.Zodrahetongemakofprobleemstopt,moetdedragerdelenzenonderzoeken.
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
Wanneerdelenzenopenigemanierzijnbeschadigd,magdedragerdelenzenNIETopnieuw
inbrengen.Hijofzijmoetdelenzenweggooienenvervangendooreennieuwe.

Alsopdecontactlenseenstofjeofeenwimperisachtergebleven,ofalshetprobleemstopt
endelensonbeschadigdlijkt,moetdedragerhetadvieskrijgendelenswegte

gooienentevervangendooreennieuwe.Alshetprobleemzichopnieuwvoordoet,magde
dragerdelensNIETmeerinbrengenenmoethijofzijONMIDDELLIJKCONTACTOPNEMEN
METDECONTACTLENSSPECIALIST.

Adviseer de drager ook om NIET een nieuwe lens te gebruiken om het probleem zelf te
verhelpen.Wijsdedragereropdatdebovenstaandesymptomenkunnenwijzenopeenernstige
aandoening,zoalsinfectie,cornealeulcer,neovascularisatieofiritis.Raaddedrageraanomzo
snelmogelijkmedischehulpensnellebehandelingtezoekenvoorhetprobleemomernstige
oogbeschadigingentevoorkomen.

Bijtherapeutischgebruikvandecontactlenzenkunnenzichbijwerkingenvoordoendieeen
gevolgkunnenzijnvanofweldebehandeldeaandoeningofverwonding,ofvanhetdragen
vandecontactlenzen.Hetismogelijkdateenbestaandeaandoeningofconditieverergert
wanneereenzachtecontactlenswordtgebruiktvoordebehandelingvaneenaangedaan
oog. Raad de drager aan om ONMIDDELLIJK contact op te nemen met de
contactlensspecialistwanneerdesymptomentijdenshetdragenvanlenzenverergerenom
ernstigeoogbeschadigingentevoorkomen.

Richtlijnenvoorlensverzorging

De contactlensspecialist dient bij het verstrekken van contactlenzen de drager alle
waarschuwingeneninstructiesvoorhetdesbetreffendelenstypeendraagschemameetedelen.
Decontactlensspecialistdienteensysteemaantebevelendatgeschiktisvoordeindividuele
vereistenvandedrager.

Hetnietnavolgenvandejuisterenigingsprocedurekanleidentoternstigoogletsel,zoals
beschrevenin hetgedeelte"Waarschuwingen". Voorvolledigeinformatie overgebruik,
verzorging,schoonmaak,desinfectieenbewarenvandeACUVUE®contactlenzenkuntuhet
instructieboekjevoorlensdragersraadplegen.

ACUVUE® contactlenzen die in tabel 1 onder de kop Dagelijks gebruik Ͳ Regelmatige
vervanging zijn vermeld, moeten telkens na het uitnemen en vóór hergebruik worden
gereinigdengedesinfecteerd.Voordedesinfecteringvandelenzenmaguitsluitendeen
chemischdesinfectiesysteemwordengebruikt(bijvoorbeeldeenallesͲinͲéénvloeistofof
waterstofperoxideoplossing).
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

Neem de richtlijnen voor contactlensverzorging door met de drager, inclusief de
basisinformatie over contactlensverzorging en het reinigen van de lenshouder, en de
specifiekeinstructiesmetbetrekkingtothetschemavoorcontactlensverzorgingdatude
dragerhebtvoorgeschreven.Aangezienbepaaldlensmateriaalsiliconebevat,zoalsintabel
1 is aangegeven, kan de bevochtigbaarheid variëren bij het gebruik van verschillende
productenvoorhetonderhoudvancontactlenzen.

Hetverzorgenvaneenplakkende(nietͲbewegende)lens

Alsdecontactlensgaatplakken(nietmeerbeweegt),moetdedragereenpaardruppelsvan
deaanbevolenbevochtigendevloeistofrechtstreeksophetoogaanbrengenenvervolgens
wachten totdat de contactlens vrij op het oog begint te bewegen alvorens deze uit te
nemen.Alsdecontactlensnaeenpaarminutennogsteedsnietbeweegt,moetdedrager
onmiddellijkcontactopnemenmetdecontactlensspecialist.

Hetverzorgenvaneenuitgedroogde(gedehydrateerde)lens

AlseenACUVUE®contactlenszichgedurendelageretijdbuitenhetoogbevindt,kanhet
lensoppervlakdroogwordenengeenvochtmeeropnemen.Vervangdecontactlensindat
gevaldooreennieuwe.

NOODGEVALLEN
De drager moet worden verteld wat te doen als er een willekeurig chemisch product
(schoonmaakproducten, onkruidverdelgers, chemische stoffen, enzovoort) in de ogen
terechtkomt:DEOGENONMIDDELLIJKSPOELENMETKRAANWATERENONMIDDELLIJK
CONTACT OPNEMEN MET DE CONTACTLENSSPECIALIST OF NAAR DE AFDELING
SPOEDEISENDEHULPVANEENZIEKENHUISGAANZONDERUITSTEL.



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
BIJWERKINGENMELDEN
Alleernstigeafwijkendereactiesenbijwerkingendiewordenwaargenomenbijdragersvan
ACUVUE®contactlenzenofdiewordenwaargenomentijdenshetgebruikvandelenzen,
dienentewordengemeldaan:

Johnson&JohnsonMedicalBV,
Computerweg14,3800ADAmersfoort
Tel:+31(0)334500500
Fax:+31(0)334500505

Aanvullendeinformatie

Voor meer informatie over ACUVUE® contactlenzen of bestellingen van gratis
instructieboekjesvoorlensdragerskuntucontactopnemenmetdeophetbovenvermelde
adres.

Fabrikant:
Raadpleegdeverpakkingvoorplaatsvanfabricage


USA:
Johnson&JohnsonVisionCare,Inc.
7500CenturionParkway
Jacksonville
Florida,32256
USA
IRELAND:
Johnson&JohnsonVisionCare(Ireland)
TheNationalTechnologyPark
Limerick
Ireland


GeautoriseerdevertegenwoordigervoordeEU:
Johnson&JohnsonMedicalLimited
PinewoodCampus
NineMileRide
Wokingham
RG403EW
UnitedKingdom
www.acuvue.com




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
7ÇER7K

ACUVUE®BrandContactLensesürünleri,lenslertamponlanmŦƔsalinsolüsyoniçindeolacak
ƔekildeayrŦsterilambalajlariçindeteminedilir(AmbalajSolüsyonlarŦiçinbkz.Tablo1).Steril
blisterambalajaçŦlmŦƔsaveyahasargörmüƔseKULLANMAYIN.

KULLANIMAMACI

ACUVUE®SphericalBrandContactLenses

Bu ürünler, Tablo 1’de gösterildiŒi gibi Günlük KullanŦm ve Uzun Süreli KullanŦm için
tasarlanmŦƔ olup gözlerinde hastalŦk bulunmayan ve 1.00D veya altŦnda astigmatizm
bulunan,afakikveyaafakikolmayankiƔilerderefraktifametropinin(miyopivehipermetropi)
optikolarakdüzeltilmesineyöneliktir.

1•DAYACUVUE®DEFINE®BrandContactLenseswithLACREON®ürünleriayrŦcagözlerin
görünüƔünüiyileƔtirmekveyadeŒiƔtirmekiçindetasarlanmŦƔtŦr.

ACUVUE®BrandContactLensesforAstigmatism

Bu ürünler, Tablo 1’de gösterildiŒi gibi Günlük KullanŦm  veya Uzun Süreli KullanŦm için
tasarlanmŦƔ olup gözünde hastalŦk olmayan astigmatizmasŦ bulunan, fakik veya afakik
kiƔilerde refraktif ametropinin (miyopluk ve hipermetropi) optik olarak düzeltilmesine
yöneliktir.

ACUVUE®BrandContactLensesforPresbyopia

Bu ürünler, Tablo 1’de gösterildiŒi gibi Günlük KullanŦm ve Uzun Süreli KullanŦm için
tasarlanmŦƔ olup gözlerinde hastalŦk bulunmayan, presbit, fakik veya afakik, 0.75D veya
altŦnda astigmatizmasŦ bulunan kiƔilerde, refraktif ametropinin (miyopi ve hipermetropi)
optikolarakdüzeltilmesineyöneliktir.

ACUVUEOASYS®BrandContactLenseswithHYDRACLEAR®PLUSürünleri,ayrŦca,aƔaŒŦdaki
akutvekronikokülerƔartlariçinbirbandajlensolarakterapötikkullanŦmadauygundur:

x
Entropiyon,trikiyazis,tarsalyaralarvetekrarlayankorneayŦpranmalarŦgibigözkapaŒŦve
korneayŦpranmalarŦndakorneanŦnkorunmasŦiçin.Ekolarak,sütürlerveyaoküleryapŦ
Ɣekil bozukluŒu, dejenerasyonu veya felci nedeniyle, korneayŦ tahriƔ olma veya
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
tekrarlanan Ɣekilde tahriƔ olmaya karƔŦ korumanŦn gerektiŒi durumlarda koruma
saŒlamakiçindekullanŦlŦrlar.
x
Büllözkeratopati,epitelyalerozyonveyŦpranma,filamenterkeratitvepostͲkeratoplasti
gibidurumlardakorneaaŒrŦsŦnŦndindirilmesiiçin.
x
Kronikepitelyalkusurlar,korneaülseri,nörotropikvenöroparalitikkeratitvekimyasal
yanŦklargibiepitelyalkusurlarŦniyileƔmesürecindebirbariyerolarakkullanmakiçin.
x
Postrefraktifcerrahi,lamellergreftler,korneafleplerivediŒerokülercerrahiƔartlarŦgibi
bandajlenskullanŦmŦnŦnuygunolduŒuameliyatsonrasŦkoƔullariçin.
x
KorneaveiliƔkiliyüzeylerin,korneasertgazgeçirgen(RGP)lenslerintakŦlmasŦnaizin
vermeyecekƔekildeaƔŦrŦdüzensizolduŒupiggybacklenstakmadurumlarŦndayapŦsal
stabilitevekorumaiçin.Ekolarak,host/grafikbirleƔimiveyayaradokusundayükselme
farklŦlŦklarŦnŦnolduŒukoƔullardalensinkullanŦlmasŦtahriƔveyŦpranmayŦönleyebilir.
ACUVUE OASYS® Brand Contact Lenses with HYDRACLEAR® PLUS ürünleri, terapötik
kullanŦm için reçete edildikleri takdirde, Günlük KullanŦm veya Uzun Süreli KullanŦm için
uygundur.
TümACUVUE®BrandContactLensesürünleri,zararlŦUVradyasyonunkorneayavegözün
içinegeçmesiniönlemeyeyardŦmcŦolmakiçinUVBlokajŦ(KorumasŦ)içerir.

UYARILAR:UVemicikontaktlensler,gözüveçevresindekialanŦntamamŦnŦkapatmadŦklarŦ
içinUVemicikenarlŦgözlüklerveyagüneƔgözlüklerigibikoruyucuUVemicigözlüklerin
yerineKULLANILAMAZLAR.UVemicigözlükleritalimatlarŦndabelirtildiŒigibikullanmaya
devametmelisiniz.

Not:UVradyasyonunauzunsüremaruzkalmakkataraktileiliƔkilendirilenriskfaktörlerinden
biridir.Maruzkalma,çevreselkoƔullar(rakŦm,coŒrafyabulutörtüsü)vekiƔiselfaktörler(dŦƔ
mekandayapŦlanetkinliklerinuzunluŒuveyapŦsŦ)gibibirdizifaktörebaŒlŦdŦr.TümACUVUE®
BrandContactLensesürünleri,zararlŦUVradyasyonunkorneayavegözüniçinegeçmesine
karƔŦkorumasaŒlamayayardŦmcŦolmakiçinUVblokajlŦ(korumalŦ)kontaktlensleriçerir.
Ancak, UV blokajlŦ kontakt lens takmanŦn katarakt ve diŒer göz hastalŦklarŦnŦn geliƔmesi
riskiniazalttŦŒŦnŦgösterenklinikçalŦƔmalaryapŦlmamŦƔtŦr.DahafazlabilgiiçinGözHastalŦklarŦ
UzmanŦnŦzadanŦƔŦn.

KULLANIMPROGRAMI

Hastalar baƔlangŦçta lensi aƔŦrŦ uzun süre takma eŒiliminde olabileceŒi için, kullanŦm ve
deŒiƔim  programŦ, Göz HastalŦklarŦ UzmanŦ tarafŦndan belirlenmelidir. Göz HastalŦklarŦ
UzmanŦ, baƔlangŦçtaki maksimum takma programŦna uymanŦn önemini vurgulamalŦdŦr.
AyrŦcaGözHastalŦklarŦUzmanŦnŦnbelirleyeceŒidüzenlikontrollerdeçokönemlidir.

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GünlükKullanŦm–GünBoyuncaKullanveAt
Tablo1’degösterildiŒigibi,GünlükKullanŦm–GünBoyuncaKullanveAt(uyanŦkhaldeyken
24saattenkŦsasürelikullanŦm)içinreçeteedilenACUVUE®BrandContactLensesürünleri,
günboyuncakullanŦlmaküzeregündebirkeztakŦlacakƔekildetasarlanmŦƔtŦrveçŦkarŦldŦktan
sonraatŦlmalŦdŦr.BuƔekildekullanŦldŦŒŦndatemizlemeveyadezenfekteetmekgerekmez.
1•DAY ACUVUE® TruEye® Brand Contact Lensleri, kontakt lens  temizleme veya
dezenfeksiyon sistemleri uygulamasŦ ile  kullanŦlmak üzere geliƔtirilmemiƔtir. Lensler
kullanŦldŦktansonraatŦlmalŦdŦr.HerbirkullanŦmsüresineyenibirlensilebaƔlanmalŦdŦr.
GünlükKullanŦmͲSŦkDeŒiƔtirme
GünlükKullanŦm–SŦkDeŒiƔtirme(uyanŦkhaldeyken24saattenkŦsasürelikullanŦm)için
reçeteedilentümACUVUE®Vita™MarkaKontaktLenslerTablo1’degösterildiŒigibi,her
ayatŦlmalŦvebiryenisiyledeŒiƔtirilmelidir.
Günlük KullanŦm– SŦk DeŒiƔtirme için reçete edilen diŒer tüm ACUVUE® Marka Kontakt
LenslerikihaftadabiratŦlmalŦveyenisiyledeŒiƔtirilmelidir.
Tablo1’degösterildiŒigibiGünlükKullanŦm–SŦkDeŒiƔtirmebaƔlŦŒŦaltŦndakitümACUVUE®
BrandContactLensesürünleri,lensinherçŦkarŦlŦƔŦndatemizlenmeli,yŦkanmalŦveyalnŦzca
birkimyasaldezenfeksiyonsistemikullanŦlarakdezenfekteedilmelidir.

UzunSüreliKullanŦm

Tablo1’degösterildiŒigibiUzunSüreliKullanŦm(uykudahil24saattenuzunsürelikullanŦm)
içinreçeteedilenACUVUE®BrandContactLensesürünleri,7gün/6gecesüreylesürekli
olarakkullanŦlabilirveçŦkarŦldŦktansonraatŦlmalŦdŦr.BuƔekildekullanŦldŦŒŦndatemizlikveya
dezenfeksiyongereklideŒildir.

Yeni kontakt lens kullanacak kiƔinin öncelikle bir Günlük KullanŦm – SŦk DeŒiƔtirme
programŦyladeŒerlendirilmesiönerilir.GözHastalŦklarŦUzmanŦnŦngörüƔünegöre,hastanŦn
Uzun Süreli KullanŦn için uygun bir aday olduŒu saptanŦrsa, Göz HastalŦklarŦ UzmanŦnŦn
hastanŦnyanŦtŦnŦtemelalanbirkullanŦmprogramŦbelirlemesiönerilir.

ÇŦkartŦldŦktansonralensinbirgeceveyadahauzunsüreyledinlenmeiçingözetakŦlmamasŦ
önerilir.GözHastalŦklarŦUzmanŦ,UzunSüreliKullanŦmŦnilkaƔamalarŦndahastayŦmuayene
etmelidir.



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
KONTRAEND7KASYONLAR

Refraktif ametropi kullanŦmŦ için reçete ederken aƔaŒŦdaki durumlardan herhangi biri
mevcutsa,ACUVUE®BrandContactLensesürünleriniKULLANMAYIN.

• GözünönkamerasŦnŦnakutveyasubakutenflamasyonuveyaenfeksiyonu.
• Kornea,konjunktivaveyagözkapaklarŦnŦetkileyenherhangibirgözhastalŦŒŦ,yaralanma
veyaanormallik.
• LakrimalsekresyonunciddiorandayetersizolmasŦ(gözkuruluŒu).
• Kornealhipoestezi(korneahassasiyetindeazalma).
• Kontakt lens takmanŦn kötüleƔtirebileceŒi veya gözü etkileyebileceŒi herhangi bir
sistematikhastalŦk.
• KontaktlenstakmakveyakontaktlenssolüsyonukullanmaknedeniyleortayaçŦkanveya
Ɣiddetlenebilenoküleryüzeyveyaadnekseaitalerjikreaksiyonlar.
x
SŦk deŒiƔtirme kullanŦm programŦ ile reçete edilen lenslerin bakŦmŦ için kullanŦlacak
solüsyonuniçindekicŦvaveyaThimerosalgbiherhangimaddeyeolanalerji.
x
Herhangibiraktifkorneaenfeksiyonu(bakteri,mantar,protozoalveyavirüsünyolaçtŦŒŦ).
x
GözkŦzarŦklŦŒŦveyagözüntahriƔolmasŦ.

Göz HastalŦklarŦ UzmanŦ, TERAPÖT7K KULLANIM AÇISINDAN, yukarŦda adŦ geçenleri de
içerebilecekbelirliokülerƔartlarŦniyileƔmesürecineyardŦmcŦolmasŦamacŦyla,ACUVUE
OASYS®BrandContactLenseswithHYDRACLEAR®PLUSürünlerinireçeteedebilir.


UYARILAR

(GünlükKullanŦm=24saattenaz,uyanŦkken;UzunSüreliKullanŦm=24saattenfazla,uyuma
süresidahil).
KontaktlenslerinvelenskutularŦdahillensbakŦmürünlerinindoŒrukullanŦmvebakŦmŦ,
güvenli kullanŦm açŦsŦndan temel esastŦr. Kontakt lenslerin veya lens bakŦm ürünlerinin
kullanŦmŦndankaynaklanansorunlar,gözdeciddiyaralanmalaranedenolabilir.

HastalarakontaktlenskullanŦmŦylailgiliaƔaŒŦdakiuyarŦlariletilmelidir:
•
ACUVUEMarkaGünlükkullanatlenslerteksefergünlükkullanŦmiçinreçete
edilirler.ÇalŦƔmalarlensbakŦmŦvekullanŦmŦileiliƔkilidiskonforveenflamasyonda
içerenbazŦkomplikasyonlarŦngünlükkullanatyumuƔakkontaktlenslerileazaldŦŒŦnŦ
göstermiƔtirvetekrarkullanŦmbuproblemlerinoluƔmasŦndandahabüyükriskeyol
açmaktadŦr.
• Kontakt lens veya lens bakŦm ürünleriyle ilgili sorunlar,gözde ciddi yaralanmalara
nedenolabilir.Hastalar,kontaktlenslerinvelenskutularŦdahillensbakŦmürünlerinin
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doŒru kullanŦm ve bakŦmŦnŦn, bu ürünlerin güvenli kullanŦmŦ açŦsŦndan temel esas
olduŒuhususundauyarŦlmalŦdŦr.†
• KorneaülserleridahilolmaküzeregözsorunlarŦhŦzlŦbirƔekildegeliƔebilirvegörme
kaybŦnanedenolabilir.
• ÇalŦƔmalar,ülseratifkeratitriskinin,uzunsürelikullanŦlanlenskullanŦcŦlarŦiçingünlük
kullanŦlanlenskullanŦcŦlarŦnagöredahayüksekolduŒunugöstermiƔtir.
• Günlük lens kullanŦcŦlarŦ lenslerini geceleri de çŦkartmadan kullanŦyorlarsa (onaylŦ
endikasyonun dŦƔŦnda), bu kullanŦcŦlar için ülseratif keratit riski lensi geceleri
kullanmayanlaragöredahayüksektir.
• Genelülseratifkeratitriski,lenskutusununtemizlenmesidedahilolmaküzerelens
bakŦmtalimatlarŦnadikkatleuyulmasŦyoluylaazaltŦlabilir.
• ÇalŦƔmalar, sigara içenkontaktlens kullanŦcŦlarŦ için ülseratif keratit riskinin sigara
içmeyenkullanŦcŦlaragöredahayüksekolduŒunugöstermiƔtir.
•
Kontaktlenslerinizi,yüzerken,diŒersusporlarŦyaparkenveyabanyoesanasŦnda
suyamaruzbŦrakmayŦnbumicroorganizmalarŦnnedenolduŒuciddigözenfeksiyon
riskiniartŦrŦrvegörmekaybŦnanedenolabilir.EŒerlenslerinizilesuyadalarsanŦz,
hastalensleriniçŦkarmalŦveyenibirçiftlensiledeŒiƔtirmelidir.SuiçindeyapŦlan
herhangibiraktivitedelenslerinkullanŦlabilmesiileilgilitavsiyealmakiçinbirgöz
saŒlŦŒŦuzmanŦnadanŦƔŦlmalŦdŦr
Hasta,gözrahatsŦzlŦŒŦ,aƔŦrŦgözyaƔarmasŦ,görmededeŒiƔiklikler,gözdekŦzarŦklŦkveyadiŒer
sorunlaryaƔarsa,kontaktlenslerihemençŦkartmalarŦsöylenmelivelensikullanankiƔiacilen
Göz HastalŦklarŦ UzmanŦyla iletiƔim kurmalŦdŦr. Kontakt lens kullanŦcŦlarŦnŦn, talimatlarda
belirtildiŒigibirutinolarakGözHastalŦklarŦUzmanŦnakontrolegitmeleriönerilir.

†NewEnglandJournalofMedicine,21september,1989,321(12),s.773Ͳ783

ÖNLEMLER

SorungörüldüŒündenyapŦlmasŦgerekenler

LÜTFEN HASTANIZA KONTAKT LENSLER7 HEMEN ÇIKARTMASINI VE GÖZ HASTALIKLARI
UZMANINDANTIBB7YARDIMALMASINISÖYLEY7N.

GözHastalŦklarŦUzmanlarŦiçinÖzelÖnlemler

LenslerinklinikaraƔtŦrmalarŦndaçokfazlasayŦdainsanyeralmadŦŒŦiçin,tümrefraktifgüçler,
tasarŦm yapŦlandŦrmalarŦ veya lens malzemelerindeki lens parametreleri, deŒerlendirme
açŦsŦndananlamlŦsayŦlarüzerindedeŒerlendirilmemektedir.Bunedenle,GözHastalŦklarŦ
UzmanŦnŦn uygun lens tasarŦmŦ ve parametrelerini seçerken lensin oksijen iletebilirliŒi,
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Ŧslanabilirlik,merkeziveperiferikkalŦnlŦkveoptikalançapŦgibilensperformansŦnŦveoküler
saŒlŦŒŦetkileyebilecekbütünniteliklerinigözönünealmalŦdŦr.

Bu faktörlerin hastanŦn oküler saŒlŦŒŦ üzerindeki potansiyel etkisi, hastanŦn refraktif
düzeltmeihtiyacŦkarƔŦsŦndadikkatlicetartŦlmalŦdŦr.BuyüzdenhastanŦndevamedenoküler
saŒlŦŒŦvegözüzerindekilensinperformansŦGözHastalŦklarŦUzmanŦtarafŦndandikkatlice
izlenmelidir.

x
Kozmetik olarak renklendirilmiƔ lenslerde ŦƔŦk geçiƔinin azalmŦƔ olmasŦna baŒlŦ olarak
1•DAY ACUVUE® DEFINE® Brand Contact Lenses with LACREON® kullanan hastalarŦn
bazŦlarŦkullanŦmsŦrasŦndagörmeileilgilisemptomlarŦtecrübeedebilirler.EkolarakbazŦ
hastalaropakirispaterninebaŒlŦçevreselgörüƔtedahaduyarlŦolabilirler.
x
Monovizyon veya multifocal kullanarak presbiyopiyi düzeltmek için ACUVUE® Brand
ContactLensesürünlerinikullananhastalar,uzaŒŦveyayakŦnŦgörmekiçineniyidüzeltilmiƔ
görüƔkeskinliŒineeriƔemeyebilir.GörmeyleilgiligereksinimlerkiƔidenkiƔiyedeŒiƔirveher
birhastaiçinenuygunlenstürünüseçerkengözönünealŦnmalŦdŦr.
x
SarŦrenklibirboyaolanflorosein,lenslertakŦlŦykenkullanŦlmamalŦdŦr.LenslerbuboyayŦ
emerverenkleribozulur.GözlerdefloroseinkullanŦldŦŒŦdurumlarda,gözdekullanŦmiçin
önerilensterilbirtuzsolüsyonuylagözleryŦkanmalŦdŦr.
• Göz HastalŦklarŦ UzmanŦ, hastaya gözlerin kŦzarmasŦ veya tahriƔ olmasŦ durumunda
lensleriderhalçŦkarmasŦyönündetalimatvermelidir.
• GözHastalŦklarŦUzmanŦ,aƔaŒŦdakibakŦmrejimivegüvenlikönlemlerihakkŦndahastayŦ
itinaylabilgilendirmelidir.

LenslereDokunmayla7lgiliÖnlemler

• GözHastalŦklarŦUzmanŦnŦnyanŦndanayrŦlmadanöncehastanŦnlensleriuygunbir
Ɣekilde takŦp çŦkartabildiŒinden veya bunu hastanŦn yerine yapabilecek bir
baƔkasŦnŦnhastayayardŦmcŦolabileceŒindeneminolunmalŦdŦr
• SterilblisterambalajaçŦlmŦƔsaveyahasargörmüƔseKULLANMAYIN.
• Kontakt lenslere dokunmadan önce eller yŦkanmalŦ ve durulanmalŦdŦr. Kozmetik
malzeme, losyon, sabun, krem, deodorant veya spreyleri gözler veya lenslerle temas
etmemelidir.Lenslerimakyajyapmadanöncetakmakeniyisidir.
• LenslerüzerindegörüƔünbozulmasŦve/veyagözezarargelmesinenedenolacakƔekilde
mikroskobik çizilmeler oluƔabileceŒinden, ellerde yabancŦ maddeler varsa kontakt
lenslereelveyaparmaklarladokunulmamasŦgerekir.
• ACUVUE®BrandContactLensesürünlerininveGözHastalŦklarŦUzmanŦnŦnreçeteettiŒi
ürünlereait“HastaTalimatKŦlavuzu”içindekikullanŦm,yerleƔtirme,çŦkarma,temizleme,
dezenfekteetme,saklamavekullanŦmtalimatlarŦnaitinaylauyulmalŦdŦr.
• LenslerherzamanitinaylatutulmalŦvedüƔürülmemelidir.
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• LensikabŦndançŦkartmakiçinaslacŦmbŦzveyabaƔkabiraletkullanmayŦnŦz.Lensi,kabŦn
yanyüzeylerindenkaydŦrarakdikkatliceçŦkartŦn.
• LensleretŦrnaklarladokunulmamalŦdŦr.
• Tüm ACUVUE® OASYS® Brand Contact Lenses with HYDRACLEAR® PLUS ürünlerinin
Terapötik kullanŦmŦ yakŦndan denetim gerektirir. Bandaj lensi ile tedavi sŦrasŦnda
kullanŦlanokülerilaçlarGözHastalŦklarŦUzmanŦtarafŦndanyakŦndanizlenmelidir.BazŦ
okülerdurumlarda,lensleriyalnŦzcaGözHastalŦklarŦUzmanŦtakmalŦveçŦkarmalŦdŦr.Bu
türdurumlarda,hastalaralensleredokunmamalarŦiçintalimatverilmelidir.

LensKullanŦmŦyla7lgiliÖnlemler

• LensgözeyapŦƔŦyorsa(hareketetmiyorsa),“YapŦƔan(hareketetmeyen)lensleriçinbakŦm”
bölümündeki tavsiye edilen talimatlara bakŦn. Gözün saŒlŦŒŦnŦ korumak için lensin göz
üzerindeserbestçehareketetmesigerekir.Lenshalenhareketetmiyorsa,hastayahemen
GözHastalŦklarŦUzmanŦnadanŦƔmasŦyönündetalimatverilmelidir.
• LensleraslaGözHastalŦklarŦUzmanŦtarafŦndantavsiyeedilensüredendahauzunbirsüre
takŦlmamalŦdŦr.
• LenslertakŦlŦykensaçspreyigibiaerosolürünlerkullanŦlŦrsa,dikkatliolunmalŦvesprey
çökenekadargözlerkapalŦtutulmalŦdŦr.
• Lens takarkenher türzararlŦ veyatahriƔ edici buharveya dumandan uzak durulmasŦ
gerekir.
• Asla baƔkalarŦnŦn lenslerinizi takmalarŦna izin vermeyin. Lensleri paylaƔmak, göz
enfeksiyonlarŦnŦngörülmeolasŦlŦŒŦnŦbüyükölçüdeartŦracaktŦr.
• Önerilen kullanŦm programŦnŦn ardŦndan, her zaman, takŦlan lensleri Göz HastalŦklarŦ
UzmanŦtarafŦndanreçeteedildiŒiƔekildeatŦn.

Solüsyonla7lgiliÖnlemler

• FarklŦsolüsyonlarherzamanbiraradakullanŦlamazvehersolüsyonunbütünlenslerle
birliktekullanŦlmasŦgüvenlideŒildir.YalnŦzcaönerilensolüsyonlarŦkullanŦn.
• HastagözdoktorunadanŦƔmadansolusyonlarŦnŦdeŒiƔtirmemelidir.
• Sertgazgeçirgen(RGP)kontaktlensleriçinönerilensolüsyonlarŦaslakullanmayŦn.
• Herzaman,yeni,kullanŦmsüresigeçmemiƔlensbakŦmsolüsyonlarŦkullanŦn.
• HerzamankontaktlenssolüsyonlarŦnŦnkullanŦmŦnayönelikprospektüslerdekitalimatlarŦ
izleyin.
• YalnŦzca (ŦsŦ deŒil) kimyasal lens bakŦm sistemi kullanŦn. IsŦ (termal) bakŦm sistemi
ACUVUE®BrandContactLensesürünlerinezararverebilir.
• KullanŦldŦklarŦ takdirde, steril korunmayan solüsyonlar talimatlarda belirtilen süre
sonundaatŦlmalŦdŦr.
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• Lensleri kayganlaƔtŦrmak veya Ŧslatmak için önerilen solüsyonlar dŦƔŦnda hiçbir Ɣey veya
tükürükkullanmayŦn.
• Lensleri kullanŦlmadŦŒŦ zamanlarda (saklarken) önerilen saklama solüsyonu içine tam
olarak batmŦƔ bir Ɣekilde bekletin. Uzun süreli kuruma lens yüzeylerinin ŦslatŦlabilir
durumagelmebecerisiniazaltŦr.LensyüzeyikuruduŒutakdirde“KurumuƔ(susuzkalmŦƔ)
lensleriçinbakŦm”bölümündekitalimatlarŦizleyin.

LensKutusuyla7lgiliÖnlemler

LenskutularŦbakterilerinüreyebileceŒibirkaynakolabilirvelenskutusuüreticisininveya
Göz HastalŦklarŦ UzmanŦnŦn önerdiŒigibi düzgün bir ƔekildekullanŦlmalŦ, temizlenmeli ve
düzenliaralŦklarladeŒiƔtirilmelidir.

HastalarlaKonuƔulmasŦGerekenDiŒerKonular

• BazŦhastalarkozmetikolarakboyanmŦƔlenslerinŦƔŦkiletimindeazalmahissedebildiŒiiçin,
kimi hastalar 1•DAY ACUVUE® DEFINE® Brand Contact Lenses with LACREON®
taktŦklarŦndabazŦbelirtilerhissedebilir.AyrŦca,opakirismodelisebebiylekimihastalar
periferalrahatsŦzlŦkdahissedebilir.
• GöziçinherhangibirilaçveyagözdamlasŦkullanŦlmadanönceherzamanGözHastalŦklarŦ
UzmanŦna danŦƔŦlmalŦdŦr.  Antihistaminikler,dekonjestanlar,diüretikler,kasgevƔeticiler,
sakinleƔtiricilervehareketbozukluklarŦnayönelikilaçlargibibelirliilaçlar,gözkuruluŒuna,
lense karƔŦ duyarlŦlŦktaartŦƔa veyabulanŦk görmeye neden olabilir. Bu tür durumlarsöz
konusuysa,uyguntedaviönlemlerinebaƔvurulmalŦdŦr
• Oral kontraseptif kullananlarda, kontakt lens kullanŦrken görmede ve lense karƔŦ
duyarlŦlŦktadeŒiƔikliklergörülebilir.HastagerektiŒigibiikazedilmelidir.
• BütünlensleriçinolduŒugibi,hastanŦngözsaŒlŦŒŦnŦnsürekliolarakkorunmasŦnŦsaŒlamak
içintakipamaçlŦgörüƔmelergereklidir.HastayatakipamaçlŦgörüƔmeprogramŦönerisi
hakkŦndabilgiverilmelidir.

HastanŦnKontaktLensTaktŦŒŦnŦKimlerinBilmesiGerekir?

• Doktorlara(GözHastalŦklarŦUzmanlarŦvediŒeruzmanlŦkalanŦndakidoktorlar)hastanŦn
kontaktlenskullanŦcŦsŦolduŒukonusundabilgiverilmelidir.
• HastanŦniƔvereninekontaktlenskullandŦŒŦhususundabilgiverilmelidir.BazŦiƔler,göz
koruma cihazlarŦnŦn kullanŦlmasŦnŦ veya hastanŦn kontakt lens kullanmamasŦnŦ
gerektirebilir.




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YANETK7LER

Hasta, ACUVUE® Brand Contact Lenses ürünleri kullanŦrken aƔaŒŦdaki sorunlarŦn
görülebileceŒihususundabilgilendirilmelidir:

• Gözleryanabilir,batmave/veyakaƔŦnmaolabilir.
• LensgözeilkkezyerleƔtirildiŒindendahaazbirrahatlŦkhissiolabilir.
• GözdebirƔeyvarmŦƔgibihissedilebilir(yabancŦcisim,gözbölgesininkaƔŦnmasŦ).
• Periferikinfiltrat,periferikkorneaülserlerivekorneayŦpranmasŦnedeniylebazŦgeçici
bozukluklar görülebilir. Lokal veya genel ödem, kornea neovaskülarizasyonu, kornea
lekelenmesi,enjeksiyon,tarsalanormallikler,iritisvekonjunktivitgibi(bunlarŦnbazŦlarŦ,
düƔük düzeylerde klinik olarak kabul edilebilirdir) diŒer fizyolojik anormallikler de
görülebilir.
• AƔŦrŦsulanma,olaŒanolmayangözyaƔŦsekresyonuveyagözkŦzarŦklŦŒŦoluƔabilir.
• Lenslerin sürekli olarak veya çok uzun bir süre takŦlmasŦ durumunda görüƔ keskinliŒi
bozulmasŦ; bulanŦk görüƔ; nesnelerin etrafŦnda ŦƔŦk halkasŦ veya gökkuƔaŒŦ benzeri
görüntülergörmeveyagözkuruluŒusemptomlarŦoluƔabilir.

Hastalardanher gün en az bir kez 3 adŦmdan oluƔan bir kontrol yapmalarŦ istenmelidir.
KendilerineƔunlarŦsormalarŦgerekir:

• GözümdekilenslernasŦlhissediyorum?
• GözlerimnasŦlgörünüyor?
• GörüƔümdebirdeŒiƔiklikhissettim?

Hasta bir sorun olduŒunu bildirirse, LENSLER7 DERHAL ÇIKARMASI talimatŦ verilmelidir.
RahatsŦzlŦkveyasorungeçerse,hastalensedikkatlicebakmalŦdŦr.LensherhangibirƔekilde
hasargörmüƔse,hastalensitekrargözüneTAKMAMALIDIR.HastalensiatmalŦvegözüne
yenibirlenstakmakiçinbaƔvurmalŦdŦr.

LenskirlenmiƔse,üzerindekirpikveyayabancŦbirƔeyvarsayadaproblemgeçmiƔvelens
hasargörmemiƔselensiatmalŦveyenibirlenstakmalŦdŦr.Sorundevamedersehastalensi
tekrar
TAKMAMALI
bunun
yerine
HEMEN
GÖZ
HASTALIKLARI
UZMANINA
BAbVURMALIDIR.

Hastaya,sorunukendisiçözmekiçinyenibirlensKULLANMAMASItalimatŦdaverilmelidir.
Hasta,
yukarŦdaki
belirtilerin
oluƔmasŦ
durumunda,
enfeksiyon,
kornea
ülseri,
neovaskülarizasyon veya iritis gibi ciddi bir durum olabileceŒi konusunda uyarŦlmalŦdŦr.
Hastaya,sorununuzmanlarcabelirlenmesivegözegelebilecekciddibirzarardankorunmasŦ
içinhementŦbbŦyardŦmalmasŦgerektiŒisöylenmelidir.

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
TerapötikkullanŦmsŦrasŦndakarƔŦlaƔŦlanyanetki,orijinalhastalŦŒaveyayaralanmayada
kontaktlenskullanmanŦnetkisisonucuortayaçŦkabilir.ÖncedenhastalŦklŦbirgözütedavi
etmek amacŦyla terapötik kullanŦm için yumuƔak kontakt lens kullanŦldŦŒŦnda mevcut bir
hastalŦŒŦn ya da saŒlŦkla ilgili bir durumun kötüleƔmesi olasŦlŦŒŦ vardŦr. Hastaya, lens
kullanŦlŦrkensemptomlardabirkötüleƔmeolmasŦdurumundagözünciddibirƔekildezarar
görmemesiiçinHEMENbirGözHastalŦklarŦUzmanŦnabaƔvurmasŦtalimatŦverilmelidir.

LensbakŦmtalimatlarŦ

LensverilirkenGözHastalŦklarŦUzmanŦ,hastanŦnlensinintürüvekullanmaprogramŦnagöre
hastayayeterliveuygunuyarŦlaryapmalŦvetalimatvermelidir.GözHastalŦklarŦUzmanŦ,
hastanŦnkiƔiselgereksinimlerinegöreuyarlanmŦƔ,uygunbirbakŦmsistemiönermelidir.

Lens bakŦmŦnda doŒru yöntemin izlenmemesi gözlere ciddi bir Ɣekilde zarar verebilir.
“UyarŦlar”bölümündebunlarŦnayrŦntŦlarŦaçŦklanmŦƔtŦr.

Kontakt lenslerin kullanŦmŦ, bakŦmŦ, temizlenmesi, dezenfekte edilmesi ve saklanmasŦ
konusunda kapsamlŦ bilgi almak için ACUVUE® Brand Contact Lenses ürünlerine yönelik
HastaTalimatKŦlavuzunabakŦn.

ACUVUE® Brand Contact Lenses ürünleri, Tablo 1’de gösterildiŒi gibi, sŦk deŒiƔtirme için
önerilmiƔse, lensler çŦkarŦldŦktan sonra ve yeniden kullanŦlmadan önce temizlenmeli ve
dezenfekte edilmelidir. Lensler, yalnŦzca bir kimyasal dezenfeksiyon sistemi kullanŦlarak
(örn.çokamaçlŦsistemveyahidrojenperoksitsistemi)dezenfekteedilebilir.

GözHastalŦklarŦUzmanŦ,lenskutusutemizliŒiileilgilitemelbilgilervehastaiçinönerilen
lensbakŦmprogramŦileilgiliözeltalimatlardahilolmaklensbakŦmtalimatlarŦnŦhastayla
birlikteincelemelidir.BazŦlensmalzemeleri,Tablo1’degösterildiŒigibi,silikoniçerdiŒiiçin
farklŦlensbakŦmürünlerikullanŦldŦŒŦndaŦslanabilirliktedeŒiƔikliklergözlenebilir.

YapŦƔan(hareketetmeyen)lensiçinbakŦm

Lens yapŦƔŦyorsa (hareket etmiyorsa) hasta, önerilen gözyaƔŦ damlasŦ veya sulandŦrma
solüsyonundan doŒrudan gözüne birkaç damla damlatmasŦ ve çŦkartmadan önce lensin
serbestbirƔekildehareketetmesinibeklemesiyönündeuyarŦlmalŦdŦr.Birkaçdakikasonra
lenshalenhareketetmiyorsa,hastahemenGözHastalŦklarŦUzmanŦnadanŦƔmalŦdŦr.
KurumuƔ(susuzkalmŦƔ)lensiçinbakŦm

ACUVUE®BrandLensürünleriuzunbirsüreiçingözdençŦkartŦlmŦƔsayüzeyikuruyabilirve
giderekŦslatŦlamazbirhalegelir.Budurummeydanagelirse,lensiatŦnveyenisinikullanŦn.
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
AC7LDURUMLAR
Herhangi bir kimyasal türünün (evde kullanŦlan ürünler, bahçe iƔlerinde kullanŦlan
solüsyonlar, laboratuvar kimyasallarŦ vb.) gözlere sŦçramasŦ durumunda, hasta, aƔaŒŦdaki
iƔlemleri yapmasŦ gerektiŒi hususunda bilgilendirilmelidir: GÖZLER7N7Z7 HEMEN SUYLA
YIKAYINVEGÖZHASTALIKLARIUZMANINDANTIBB7YARDIMALINVEYAGEC7KMEKS7Z7N
B7RHASTANEN7NAC7LSERV7S7NEG7D7N.
TERSETK7LER7NB7LD7R7LMES7

ACUVUE®BrandContactLensesürününükullananhastalardagözlemlenenveyalenslerle
ilgiliolarakgörülenciddidüzeydekitümtersetkivesorunlaraƔaŒŦdakiadresebildirilmelidir:

Johnson&JohnsonSihhiMalzemeSan.veTic.Ltd.bti.
MehmetÖzçelik7ƔmerkezErtürkSok.No:5
34810KavacŦkͲBeykoz/7stanbul
Tel:02166803781
Faks:02163310806
























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
Ekbilgiler

ACUVUE®BrandContactLensürünleriyleilgiliekbilgileralmakveACUVUE®BrandContact
Lenses ürünlerine yönelik Hasta Talimat KŦlavuzlarŦnŦn ücretsiz kopyasŦnŦ edinmek için
yukarŦdakiadrestekiMüƔteriHizmetleriileiletiƔimkurabilirsiniz.

Üretici:
ÜretimtesisiiçinlütfenkutuyabakŦn




USA:
Johnson&JohnsonVisionCare,Inc.
7500CenturionParkway
Jacksonville
Florida,32256
USA
IRELAND:
Johnson&JohnsonVisionCare(Ireland)
TheNationalTechnologyPark
Limerick
Ireland

ABYetkiliTemsilcisi:
Johnson&JohnsonMedicalLimited
PinewoodCampus
NineMileRide
Wokingham
RG403EW
UnitedKingdom
www.acuvue.com
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CR-6291, v1.0
 
 
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64
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(IN000327) 
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©Johnson&JohnsonMedicalLimited.2017
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ACUVUE®2®, 1•DAY ACUVUE®, 1•DAY ACUVUE® MOIST, ACUVUE® ADVANCE® with HYDRACLEAR®, ACUVUE OASYS® with
HYDRACLEAR®PLUS,ACUVUEOASYS®withHydraLuxeTM,VITATM,1•DAYACUVUE®TruEye®,ACUVUE®ADVANCE®PLUSwith
HYDRACLEAR®,1•DAYACUVUE®DEFINE®withLACREON®,aretrademarksofJohnson&JohnsonMedicalLimited
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Revisiondate:August2017
ACUVUE®
BrandContactLensesPackageInsert
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IN000327
CR-6291, v1.0
 
 
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JJVC CONFIDENTIAL

  LENS FITTING CHARACTERISTICS
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CR-6291, v1.0
 
 
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CR-6291, v1.0
 
 
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CR-6291, v1.0
 
 
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JJVC CONFIDENTIAL

 PATIENT REPORTED OUTCOMES
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CR-6291, v1.0
 
 
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JJVC CONFIDENTIAL

APPENDIX 
E:
METHODOLOGY 
FOR 
PREPARATION 
AND
OCULAR 
INSTILLATION OF FLUORESCENT MICROSPHERES

Methodology for the ocular instillation of fluorescent microspheres
1)
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For dispensing of microsphere suspension directly onto ocular surface:
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For dispensing of microsphere suspension onto the back surface of a contact lens prior to 
application (RE Only):
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CR-6291, v1.0
 
 
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JJVC CONFIDENTIAL

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CR-6291, v1.0
 
 
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JJVC CONFIDENTIAL

APPENDIX F: EUROLENS RESEARCH SOP ‘THE SET-UP, MEASUREMENT OF 
VISUAL ACUITY AND PROCEDURES FOR CARRYING OUT AN OVER 
REFRACTION USING THE EUROLENS COMPUTERIZED LOGMAR VA CHART’
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12a 
 
 
 
 
 
 
 
 
Eurolens Research 
 
Clinical 
Standard Operating Procedure 
 
 
 
 
 
The set up, measurement of visual acuity and 
procedures for carrying out an over refraction 
using the Eurolens computerised logMAR  
VA chart  
 
 
 
 
 
Neil Chatterjee 
Research Optometrist 
 
 
First issued: v0; July 8, 2009 
Reviewed (with changes): v1; February 7, 2014 
Reviewed (no changes): v1; February 2, 2016 
Reviewed (with changes): v2; December 19, 2017 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
4 
Confidential 
 
Microsoft Excel software.  The chart is displayed through an external monitor 
connected to the Apple Mac via its monitor socket and appropriate cable. 
2. The Eurolens chart is similar in design to the traditional Bailey-Lovie logMAR chart, 
however it uses a reversed Sloan font as the optotype.  The need for the reversed 
font is due to the chart being viewed indirectly in a mirror in a 3m consulting room.  
The chart is mounted on an adjustable mount, above the subject’s head. 
3. The indirect viewing makes the effective distance of the chart 6m from the subject.  
This 6m distance is the standard testing distance in optometric practice. 
4. High (100%) and low (10%) contrast VA measurements can be taken with the chart. 
5. The VA measurement from the Eurolens chart is intended to be equivalent to that 
obtained from the traditional Bailey-Lovie logMAR charts at 6m.  The Eurolens chart 
has two advantages over the Bailey-Lovie.  The Eurolens chart does not fade or 
discolour (which reduces legibility).  Further, unlike the fixed Bailey-Lovie chart, the 
letters can be randomised on the Eurolens chart, which reduces the effect of memory 
influencing the subject’s VA score. 
 
Initial computer set up 
1. 
The Apple Macintosh should have the following installed:  
a. Reversed Sloan font (otf file, which should be copied to the Macintosh 
HD/Library/Fonts/ folder) 
b. Microsoft Office 2011 or later 
c. Eurolens chart v5 software 
2. 
The external monitor should be connected to the Mac.  It will require the use of an 
appropriate adaptor and cable. 
3. 
The additional monitor should be recognised automatically by the Mac.  The Mac 
should configure the monitor as a second desktop.  To verify this, move the mouse 
pointer across the screen.  It should be possible to move the mouse pointer off the 
edge of the main screen and it should appear on the external monitor. 
4. 
The Eurolens Chart software is an Excel file called Eurolens Research chart.xls.  
This, for convenience, is located on the desktop. 
5. 
To run the chart, open the Excel file.  Click on “enable macros”. 
6. 
The chart should be displayed on the external monitor and the chart’s control panel 
should appear on the Mac’s main screen (Figure 1). 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
5 
Confidential 
 
 
Figure 1.  Chart control panel 
 
7. 
If the letter chart appears on the Mac’s main screen, it will need to be “dragged” onto 
the external monitor.  To do this the chart control box must be closed.  The main 
chart can now be dragged onto the second screen and maximised. 
8. 
To restart the control panel, click on the Excel icon in the dock.  Then in Excel’s 
menu, select.: Tools -> Macro-> Macros.  A macro box should appear, select the 
macro entitled ‘showform’ and click on run.  The chart’s control panel can be 
reopened if closed (e.g. accidentally) by repeating this step. 
 
Chart calibration procedure 
1. 
It is important the charts are calibrated before first use, to ensure the optotypes are 
of the correct size and contrast.  Minute adjustments of monitor contrast or 
brightness can affect the contrast of the letters (especially low). 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
6 
Confidential 
 
2. 
If the chart distance is set to 6m, the 0.8 letter on the computer chart should be the 
same height as that on the Bailey-Lovie chart, measuring just under 55mm high. 
3. 
The chart distance should then be set to the distance of the subject’s head to the 
chart. 
4. 
The monitor should be inclined downwards at an angle of approximately five 
degrees from the vertical.  The reason being the contrast of an LCD monitor can 
vary with tilt.  At five degrees of inclination, the monitor will be ‘straight on’ for the 
subject sat on the chair below. (see Appendix A) 
5. 
The monitor should then be calibrated using a Datacolor Spyder 4. Whilst 
calibrating, the room lights should be on full illumination and the monitor set to 
factory default values (all setting “standard”).  The corresponding monitor profile file 
generated should be saved and then used as the profile for the external monitor. 
6. 
The contrast of the low contrast chart should be measured.  The test spreadsheet 
(low contrast grey test.xlsx) should be displayed on the monitor with room lights on.  
Measurements of the luminance of the grey and white halves are taken with the 
spyder.  The luminance measurements are then averaged.  The contrast of the grey 
to white backgrounds is calculated as follows: 
 
% contrast = 
 
white lum – grey lum  x 100 
 
 
 
 
white lum  
7. 
The RGB vales of the grey background should be altered until the contrast is 
calculated to be approximately 10%.  This value is usually between 240 and 245 
units. 
8. 
Acuity measurements on the freshly calibrated chart should then be compared to 
those taken with two already calibrated charts.  This is done by measuring high and 
low contrast visual acuity with all three charts (in a randomised order on around 
eight subjects).  The acuity measurements of the three charts should all agree within 
two letters (0.04 logMAR) for high and low contrast acuity. 
9. 
If the high contrast acuity on the test chart does not agree with that of the control 
charts, then the “chart distance” value should be altered on the test chart, until it is in 
agreement with the controls. 
10. Once the high contrast acuity values are in agreement, the test chart’s low contrast 
acuity should be in agreement with the control.  If not then the “LC grey” value 
should be altered on the test chart until agreement is reached. 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
7 
Confidential 
 
11. Final settings for each monitor on 11 October 2017 are contained in Appendix B. 
 
Measurement of VA using the Eurolens chart 
General instructions 
 
1. 
The subject should be seated in the chair 3m from the mirror.  This will place the 
chart at a 6m testing distance. 
2. 
The default test chart for standard testing should be a 7-line chart ranging from 0.4 
to -0.2 (Figure 1). 
3. 
The subject’s acuity can be tested monocularly and/or binocularly according to the 
study protocol. 
4. 
If the subject cannot read the top line then increase letter size in 0.1 steps until the 
subject can see the top line.   
5. 
Adjusting the “number of lines” box can alter the number of rows of letters displayed 
on the chart.  Please note to display larger letters (over 0.4), then only one or three 
rows should be selected.  
6. 
Letters can be increased in size by 0.1 steps, by clicking on the “+0.1” box.  Letters 
can be increased in size to a maximum of 1.0. 
7. 
Letters can be decreased in size by clicking on “-0.1”. 
8. 
The control panel displays information on the optotypes currently displayed on the 
chart and their size in logMAR. 
9. 
The VA score is calculated using the same method as a traditional Bailey-Lovie 
chart, with each letter scoring 0.02 units and each complete line scoring 0.1 (see 
below). 
10. To display the high contrast chart select “high contrast”, similarly to display the low 
contrast chart select “low contrast”.  This will display letters of 100% and 10% 
contrast respectively 
11. The Mac generates the sequence of letters used in the chart randomly.  Clicking on 
“shuffle letters” can change the sequence of letters. 
12. Letters should be shuffled after each VA measurement to avoid the subject learning 
the chart. 
13. As the chart is at 6m, any over-refraction performed can be considered to be 
equivalent to that performed on a 6m Snellen chart i.e. at infinity. 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
8 
Confidential 
 
14. The 6m testing distance should also be taken into account when comparing logMAR 
scores obtained with the Bailey-Lovie chart at 3m.  The Bailey-Lovie scores should 
differ by -0.3. 
 
Subject instructions (standard chart display) 
After positioning the subject at the desired test distance, initiate the testing as follows: 
1. 
Ask the subject to read the smallest line where they feel they can easily read all the 
letters.  If the subject reads all the letters on the initial line, encourage them to 
continue reading the smaller lines until three or more letters on a 5- letter line are 
incorrectly identified. 
2. 
If the subject identifies one letter incorrectly on the initial line, ask them to read the 
line(s) above until one complete line has been identified correctly. Then encourage 
the subject to continue reading the smaller lines/letters until three or more letters on 
a 5-letter line are incorrectly identified. Note: The subject is to be encouraged to 
read and even guess at the letters until three or more letters are incorrectly 
identified. 
Scoring 
To determine the VA unit score for a given line: Take the maximum VA for the last line 
read (i.e. the line on which three or more letters were missed) and add +0.02 for every 
letter missed on the chart. 
For example: 
i) 
 0.00 line 
3 letters missed 
logMAR score +0.06 
 
ii) 
+0.20 line 
0 letters missed 
+0.10 line 
2 letters missed 
  
 0.00 line 
3 letters missed 
logMAR score +0.10 
 
iii) 
-0.20 line 
0 letters missed 
-0.30 line 
2 letter missed 
-0.40 line 
4 letters missed 
logMAR score –0.28 
 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
9 
Confidential 
 
Over-refraction 
Unless the clinical study protocol states otherwise the following procedures should be 
carried out: 
1. 
Visual acuity using the Eurolens chart will be measured with no over-refraction in 
place.  The study protocol may require that this be carried out monocularly or 
binocularly. 
2. 
A binocular over-refraction should be carried out using the chart at 6m.  This 
procedure will control accommodation and allow accurate assessment of the 
subject’s visual status.  These results will allow the Investigator to judge whether or 
not the contact lens BVP is acceptable. 
Bailey Lovie chart 
LogMAR visual acuity can also be measured on a card-based Bailey-Lovie chart.  The 
use of this chart is covered in more detail in the relevant SOP1.  In summary the 
differences are: 
1. 
Unless specified the Bailey-Lovie chart is used at a testing distance of 3m as it is 
viewed directly. 
2. 
The font used (5x5 sans-serif font)2 is that defined in the British Standard: BS 4274.  
3. 
If the Bailey-Lovie is used at 3m, then it should not be used as a target to determine 
over-refraction.  Instead an alternative chart (e.g. Snellen) positioned at 6m should 
be used. 
 
References 
1. 
Eurolens Research Standard Operating Procedure.  Assessment of visual 
performance using the Bailey-Lovie logMAR visual acuity test chart and procedures 
for carrying out an over-refraction. 
2. 
BS 4274-1:2003.  Visual acuity test types. Test charts for clinical determination of 
distance visual acuity – Specification.   
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
10 
Confidential 
 
 
Appendix A.  Screen inclination calculation 
 
To calculate chart inclination 
 
Tan (angle of chart inclination) = Subject’s distance below chart 
 
 
 
     Subject to chart distance (parallel to floor) 
Room 
1.015  
1.014  
1.013 
1.012 
Subject’s 
distance below 
chart (eye to top 
of monitor) (cm)* 
50 
65 
 
65 
65 
Subject to chart 
distance (parallel 
to floor) (cm) 
600 
605 
610 
600 
Calculated chart 
inclination 
(degrees) 
4.7 
6.1 
6.1 
6.2 
Table 2: Eurolens clinic room screen inclination. 
 
* Subject with Eurolens ID 2023 of  average UK male height (175cm, ONS data) was 
used 
 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
11 
Confidential 
 
Appendix B.  Example of chart settings (11 October 2017) 
 
Clinic room 
1.012 
1.013 
1.014 
1.015 
1.018 
Monitor number  4 
5 
3 
1 
2 
Chart distance 
(m) 
6.0 
6.1 
6.05 
6.0 
6.1 
LC grey 
240 
240 
243 
240 
237 
 
Table 3: Eurolens clinic room chart settings 
All monitors calibrated were a BenQ G2255 displaying the chart at native resolution 
(1920x1080). 
 
Appendix C.  Revisions to chart software 
2008 
Initial clinic version of computer chart software 
 
01/02/2013 v5 
2013 version of chart software was rewritten for compatibility with Office 2011 and Mac 
OSX10.8.  Contains the following amendments: 
 - Colours of the control box have been altered for better legibility with office 2011 
 - Chart letter display was updated for 16:9 monitors 
 - Letter size is calculated correctly for chart distance 
 - Low contrast letters contrast adjustable from chart control panel.  
 
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JJVC CONFIDENTIAL

APPENDIX G: EUROLENS RESEARCH SOP ‘EXAMINATION OF THE ANTERIOR 
SEGMENT USING SLIT LAMP BIOMICROSCOPY’
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JJVC CONFIDENTIAL

 
 
 
 
 
 
 
 
Eurolens Research 
 
 
 
 
Clinical 
Standard Operating Procedure 
 
 
 
 
Examination of the anterior segment 
using slit lamp biomicroscopy 
 
 
Carole Maldonado-Codina 
Associate Director 
 
 
First issued: v0; May 20, 2002 
Reviewed (with changes): v2; June 26, 2009 
Reviewed (no changes): v2; October 14, 2011 
Reviewed (with changes): v3; March 4, 2014 
Reviewed (with changes): v4; February 2, 2016 
Reviewed (no changes): v4; February 5, 2018 
 
 
 
 
 
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Eurolens Research                     Slit lamp biomicroscopy (v4) 
   February 2, 2016 
 
 
 
                                           
          
 Confidential 
3 
Summary 
The slit lamp biomicroscope is a high quality illuminating observation system which 
allows the external and internal ocular structures to be assessed in detail. The Efron 
Grading Scales for Contact Lens Complications1 will be used to quantify most of the 
observations made.  If an alternative grading scale is to be used this will be detailed in 
the study protocol. 
 
Definitions 
External ocular structures in this procedure refer to the following structures: conjunctiva, 
sclera, limbus and associated blood vessels, cornea, lids, lashes and tear film.  
Internal ocular structures in this procedure refer to the anterior chamber. 
Wratten 12 filter – A yellow filter which enhances the contrast of fluorescein staining 
when viewed using cobalt blue light. 
 
Procedure 
1. Using the recommended settings for slit width, magnification and filter, examine 
the external and internal ocular structures2. The following primary signs should 
be graded using the Efron Grading Scales: conjunctival redness, limbal redness, 
corneal neovascularisation, epithelial microcysts, corneal oedema and corneal 
infiltrates. The following secondary signs are also usually graded using the Efron 
Grading Scales: blepharitis and meibomian gland dysfunction. The number of 
mucin balls present are counted and recorded. 
2. Instil sodium fluorescein (using a fluorescein ophthalmic strip wetted with saline) 
in both eyes and using cobalt blue light and a Wratten 12 filter or similar yellow 
filter, examine and grade the following: corneal and conjunctival staining.  The 
location and ‘type’ of any staining is also usually recorded. Corneal staining type 
is usually divided into the following categories: no staining, toxicity, SEAL, foreign 
body/abrasion, inferior dehydration and non-specific. 
3. The upper eyelid should then be everted and examined both with cobalt blue light 
(with the yellow filter in place) and with white light (no filter in place).  The grading 
of upper palpebral conjunctivitis should then be made with the Efron Grading 
Scales.   
4. If a soft contact lens needs to be applied after the examination, irrigate the eye 
with unpreserved sterile saline once the examination has been completed in 
order to remove excess sodium fluorescein. 
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JJVC CONFIDENTIAL

APPENDIX H: CRITERIA FOR ASSESSMENT OF OPTIMAL/NON-OPTIMAL 
LENS APPLICATION AND EYEGENIE TECHNIQUE.

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Criteria for assigning a subject as having either optimal or non-optimal lens application 
technique:
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Criteria for assigning a subject as having either optimal or non-optimal Eyegenie 
technique:
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CR-6291, v1.0
 
 
Page 170 of 175
JJVC CONFIDENTIAL

APPENDIX I: IMAGE CAPTURE SYSTEM AND PROCEDURES
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Specification of the image capture system 
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CR-6291, v1.0
 
 
Page 171 of 175
JJVC CONFIDENTIAL

APPENDIX J: BLINK ANALYSIS
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CR-6291, v1.0
 
 
Page 172 of 175
JJVC CONFIDENTIAL

APPENDIX K: VAS SCALE

CR-6291, v1.0
 
 
Page 173 of 175
JJVC CONFIDENTIAL

PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
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CR-6291, v1.0
 
 
Page 175 of 175
JJVC CONFIDENTIAL