Guidance for Industry
Guidance for Premarket
Submissions of Orthokeratology
Rigid Gas Permeable Contact
Lenses
Document issued on April 10, 2000
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Vitreoretinal & Extraocular Devices Branch
Division of Ophthalmic, Ear, Nose and Throat Devices
Office of Device Evaluation Preface
Public Comment:
Comments and suggestions may be submitted at any time for Agency
consideration to
James F. Saviola, O.D.
DOED/VEDB/HFZ-460
9200 Corporate Blvd, Rm 250
Rockville, MD  20850
Comments may not be acted upon by the Agency until the document is next revised
or updated.  For questions regarding the use or interpretation of this guidance contact
James F. Saviola, O.D. at 240 276-4232 or by electronic mail at
james.saviola@fda.hhs.gov
Additional Copies:
World Wide Web/CDRH/ home page:  http://www.fda.gov/cdrh/ode/guidance/1134.pdf
or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 1134
when prompted for the document shelf number. TABLE OF CONTENTS
1.   INTRODUCTION...............................................................................................................4
2.  PRECLINICAL.....................................................................................................................6
3.  CLINICAL............................................................................................................................7
A. Introduction..............................................................................................7
B. Project Goals............................................................................................7
C. Patient Selection.......................................................................................7
D. Protocol....................................................................................................8
E. Issues.......................................................................................................9
F. Results...................................................................................................10
G. Additional Considerations for Overnight Wear Studies
(Prospective Investigations)....................................................................13
H. Retrospective Data.................................................................................13
I. Recommended Orthokeratology Data Tables..........................................14
4.  SHIPPING CONTAINER LABEL......................................................................................23
5.  PACKAGE INSERT...........................................................................................................24
6.  PATIENT INFORMATION BOOKLET (PART 1) FOR POTENTIAL USERS:................36
7.  PATIENT INSTRUCTIONS (PART 2) AFTER YOUR TN (generic name)
RIGID GAS PERMEABLE CONTACT LENSES FOR ORTHOKERATOLOGY
HAVE BEEN FITTED........................................................................................................46
8.  PROFESSIONAL FITTING AND INFORMATION GUIDE.............................................57 1
Guidance  for Premarket Submissions of
Orthokeratology Rigid Gas Permeable
Contact Lenses
1.  INTRODUCTION
This guidance document is intended to provide guidance for rigid gas permeable (RGP)
contact lens manufacturers that submit marketing applications for contact lenses intended for
use as orthokeratology devices.  A large segment of the document is devoted to a labeling
template that includes the primary package, a package insert, a practitioner fitting guide and a
two part patient booklet.  Detailed examples of specific labeling components required by
regulation are provided.  A primary goal of the labeling is to communicate reasonable
expectations of success to the user.
In order to develop the necessary information for the labeling, the clinical portion of the
guidance identifies specific recommendations for a clinical protocol to develop performance
data for submission of a daily wear premarket notification (510(k)) or an overnight wear
premarket approval application (PMA).  These clinical criteria are recommended to
adequately demonstrate safety and effectiveness for the intended use of temporary reduction
of refractive error.  Sample data reporting tables that are supplemental to the standard contact
lens clinical data reporting tables found in the clinical sections of previous contact lens and
lens care guidance documents are also included.
The preclinical aspects that are necessary to demonstrate the safety and effectiveness of the
device for its intended use are incorporated by reference to previous contact lens guidance
documents and are not repeated in this document.
We consider clinical studies of contact lenses for daily wear to be non-significant risk,
whereas studies of overnight use or extended wear to be significant risk investigations.
Significant risk investigations require an IDE.  For overnight or extended wear contact lens
studies an adequate investigational plan and informed consent document should be presented
to an institutional review board (IRB) and the Food and Drug Administration (FDA) for
review and approval.  IRB approval is always required before initiating a clinical study of
both significant risk and non-significant risk devices while significant risk studies require
both IRB and FDA approvals before initiating clinical testing.
                                               
1 This document is intended to provide guidance.  It represents the Agencys current thinking
on this topic.  It does not create or confer any rights for or on any person and does not
operate to bind FDA or the public.  An alternative approach may be used if such approach
satisfies the requirements of the applicable statute, regulations, or both.
Page 4 of 72 Clinical data should be obtained in accordance with an investigational plan that will ensure
subject protection and the development of data adequate to support the safety and
effectiveness of the device for its intended use.
The information in this guidance document is intended to assist persons in the collection and
preparation of data for a 510(k) or PMA submission.  This document does not create legal
requirements.  It identifies the preclinical and clinical areas that FDA believes should be
addressed to establish valid scientific evidence as required by the act. The use of this
document to prepare preclinical and clinical protocols will not ensure IDE approval, PMA
approval, or 510(k) clearance.  By following the recommendations in this document the
necessary aspects of a submission should be addressed.
One may either follow the recommendations in this guidance document or use different data
collection protocols and analysis procedures.  We are available to discuss alternative
approaches in advance to help prevent the expenditure of time and effort on activities that
may not address the relevant issues associated with these devices.
Preclinical or clinical data in other documents on file with CDRH may be incorporated by
reference.  To be referenced, documents such as IDEs, 510(k)s, PMAs or device master files
(DMFs) should have been submitted by the applicant, or the applicant should provide CDRH
with appropriate authorization from the holder.  This authorization should be in the form of a
letter addressed to the Document Mail Center, HFZ-401, CDRH, 9200 Corporate Blvd.,
Rockville, Maryland 20850, referencing the correct document number.
The Division of Ophthalmic, Ear, Nose and Throat Devices (DOED) should be consulted if
you have questions concerning remain this guidance document.  DOED's telephone number
is 301-594-1744.
Page 5 of 72 2.  PRECLINICAL
The preclinical areas that should be addressed consist of manufacturing/chemistry,
toxicology, and microbiology information.  The guidance for preclinical information is
referenced to the Premarket Notification (510(K) Guidance Document for Daily Wear
Contact Lenses dated May 12, 1994, or the most current version.  The types of manufacturing
data and preclinical testing that should be completed prior to seeking IDE approval from an
IRB and FDA, or prior to submitting a 510(k) or PMA for review are contained therein.
Each section includes a summary of the basic requirements and suggested methods for
meeting these requirements.
A manufacturer may be able to address many of the preclinical aspects by reference to an
approved PMA or SE 510(k) for the material.  If the material to be used for the
orthokeratology lens is obtained from another source, a letter of reference may be obtained
from the material supplier.
Guidance for color additive requirements and procedure for adding lens finishing laboratories
for manufacturing and marketing of RGP contact lenses are incorporated by reference to the
aforementioned Premarket Notification (510(K) Guidance Document for Daily Wear Contact
Lenses dated May 12, 1994.
Page 6 of 72 3.  CLINICAL
A.  Introduction
The clinical portion of this document includes additional elements of specific clinical
data collection and suggested methodologies to be included in the protocol.  This is in
addition to the information included in the Premarket Notification (510(K) Guidance
Document for Daily Wear Contact Lenses dated May 12, 1994.  The clinical protocol
is part of the investigational plan and should be submitted to an IRB and FDA in
order to obtain approval of an IDE.
The design of an investigation to demonstrate the safety and efficacy of
orthokeratology (also known as Precise Corneal Molding, Controlled Kerato-
Reformation, Ortho Focus, etc.) may involve daily wear and/or overnight (sleep time)
wear of rigid gas permeable lenses employing a reverse geometry design.  As this
procedure has been practiced for the past several years, retrospective clinical data
may be useful in establishing endpoints in the design of a prospective study.
B.   Project Goals
The study goals should be clearly stated, including definitions of success that are
defined in objective, quantifiable parameters.
For example, success should be defined as:
  A specific level of uncorrected visual acuity,
  A level of stability of corneal topographic eccentricity values,
  A level of attempted versus achieved reduction in manifest refractive error
(the proportions of subjects within  0.50,  1.00, and  2.00 of the targeted
amount of correction).
The unaided acuity (manifest acuity) and changes in refraction that occur with the
procedure are to be emphasized.  It is recommended that a LogMAR Chart (also
known as EDTRS) be used although a Snellen Chart is acceptable.
C.  Patient Selection
This should include any known factors that would qualify or disqualify an individual
as being suitable candidate for Ortho K.  If there are specific goals or labeling claims
in mind, we recommend subsets of special cases to support those goals or labeling
claims.
Page 7 of 72 Examples of entrance criteria may include but are not limited to:
  Degree of myopia, such as -4.00 diopters or less,
  Level of corneal eccentricity as measured by corneal topography,
  Degree of corneal and refractive astigmatism,
  Stability of pre-treatment refractive error,
  History of corneal refractive surgery,
  Ocular health status, especially, corneal,
  Systemic health conditions that have ocular/corneal components,
  Medications having ocular/corneal effects, and
  Reproductive status for female subjects.
D. Protocol
In developing the protocol, a number of issues should be considered.
  What are the desired labeling claims?
  What are the specific goals of the study?
  What are the inclusion and exclusion criteria for the subjects?
Multi-center data would provide information on the consistency of results from the
methodology applied and eliminates the inherent bias in utilizing only one
investigator.
A study of 50 to 60 completed subjects from a minimum of 3 to 5 clinical sites is
recommended for a daily wear orthokeratology study.  The patients should be
followed for a minimum of three (3) months, although a longer period may be
necessary to reach defined stability.
Stability should be defined by quantifiable measures such as:
  the determination of when the eccentricity (e) value reaches 0,
  lack of change in corneal topography readings,
  a change in refractive error of  0.50 D as determined by two consecutive
refractions performed at a specific time interval,
  unaided visual acuity changes (also determined by two consecutive assessments
performed at a specific time interval).
The proposed values and endpoints for these variables may be projected from
retrospective data documented in the literature or verifiable unpublished clinical
reports.
For an overnight or extended wear study please refer to section G below.
Page 8 of 72 E.  Issues
The practitioners should follow an established methodology during the study.  This
will allow the sponsor the opportunity to collect data that is combinable for statistical
analysis. The following data should be collected during the study:
 
  Number of patients screened.
  Number of patients entered into the program based on the established
inclusion and exclusion criteria for selecting patients.
  Number of previous PMMA and/or RGP lens wearers (data should be
reported separately for previous PMMA and/or RGP wearers vs. soft lens or
new wearers.
Established endpoints of efficacy:
  Number of lines of reduction of uncorrected acuity.
  Amount of change of corneal curvature to induce refractive error changes.
  Number of patients whose uncorrected acuity is 20/40, 20/30, or 20/20 or
better at 1 month and every 3 month follow up.  Analyze data with respect to
pretreatment data in the patient record.
  A level of attempted versus achieved reduction in manifest refractive error
(the proportions of subjects within  0.50,  1.00, and  2.00 of the targeted
amount of correction for the follow-up intervals from the time-point of
stability out to the end of the study).
  Stability should be defined by quantifiable measures such as the
determination of when the eccentricity (e) value reaches 0, lack of change in
corneal topography readings, a change in refractive error of  0.50 D as
determined by two consecutive refractions performed at a specific time
interval, and unaided visual acuity changes (also determined by two
consecutive assessments performed at a specific time interval).
  Number and criteria for discontinuance of patients.
  Length of time wearing the orthokeratology lens prior to changing over to
the Myopic Reduction Maintenance Lens (MRML) or the retainer lens.
  Longevity of procedure with minimum wear time of retainer lens after
stability of refractive reduction is achieved.
Established safety parameters:
  Signs/Symptoms, Complications, Adverse Events, Slit Lamp Findings, and
the associated grading scales for these findings; K-readings or Corneal Maps
and noted changes.
  Loss of baseline Best Corrected Visual Acuity of 2 or more lines and 1 or
more lines.
  Increase in corneal/refractive astigmatism of 2D or more and 1D or more as
compared to baseline.
Page 9 of 72   Identification of lens/mold fittings and criteria used to ascertain the needs for
these changes and lens replacements with reasons.
Design and wearing schedule of retainer lenses,
  Average number hours worn per day, or per week ( a patient diary may be
necessary to accurately collect wear time data);
  Associated signs, symptoms, complaints, complications, adverse events, slit
lamp findings.
  Patient information; brochures, informed consent, program description.
 
F.  Results
The above information should be collected, analyzed, and presented in tabular form
by the sponsor to address the following points:
Sample data tables that should be completed in addition to the standard data
reporting tables contained in the Premarket Notification (510(K) Guidance Document
for Daily Wear Contact Lenses dated May 12, 1994 are included in the appendices to
this section.
The following types of data analyses are considered important for the evaluation of
safety and effectiveness.
1.  Keratometry or Corneal topography:
Summary statistics do not provide an accurate description of the effects of
orthokeratology.  For this reason, FDA recommends the following analysis for
keratometry and/or corneal topography.
  An analysis of changes in keratometry measurements stratified by diopters
(keratometric) and meridia should be provided.
  An analysis of change in absolute corneal astigmatism should also be
provided.
  Analysis of corneal topography for changes in eccentricity along with
changes in the steep and flat meridia would provide additional information
in place of keratometry.
2.  Refractive Power:
An analysis of reduction of refractive error by pre-treatment manifest refraction
should be provided.  This should include:
Page 10 of 72   An analysis of pre-treatment refractive parameters stratified by sphere and
cylinder for subjects having astigmatic myopia.
  An analysis of pre-treatment refractive parameters in comparison to post-
treatment refractive parameters stratified by dioptric power for all
completed subjects at the 1 month and 3 month visits for daily wear and
the 6, 9, and 12 month visits for overnight wear.
  An analysis of the intended correction versus the achieved correction
stratified by dioptric power for all subjects as well as subjects completing
all visits.
  It is important for the practitioner to know when the patient has achieved
the maximum amount of reduction in refractive error that is going to be
achieved with orthokeratology so that the patient can be placed on a
maintenance program.
  A definition and method of determining refractive stability for the
orthokeratology procedure should be provided. A change in refractive
error of  0.50 D determined by two consecutive refractions performed at a
specific time interval should be included in this objective definition.  The
proposed values and endpoints for these variables may be projected from
retrospective data documented in the literature or verifiable unpublished
clinical reports.
  An analysis of the stability of the manifest refraction should be performed
for all eyes treated; for eyes treated for spherical myopia (and for eyes
treated for astigmatic myopia if applicable).
  This analysis should be performed for the overall cohort and on all
subjects who were seen at all visits specified in the protocol and stratified
by dioptric group, evaluated at the 95% confidence interval for the mean
difference (not the difference in the means).
  An analysis of the relationship between changes in keratometric readings
(or topographical changes) and corresponding reductions in manifest
refraction for  the overall cohort and subjects completing all visits
specified in the protocol, stratified by dioptric group should be provided.
3.  Visual Acuity:
The intended purpose of orthokeratology is the reduction of myopic refractive
errors so those individuals may reduce the need for corrective lenses for
functioning.  The practitioner needs to know what effects (namely the degree of
improvement in uncorrected visual acuity) that can be obtained by the
programmed reformation of the corneal surface induced by the reverse geometry
Page 11 of 72 process of the contact lens.  To address these objectives, the following data should
be presented in the marketing application:
  An analysis of uncorrected visual acuity pre- and post-treatment for
subjects who completed all visits stratified by dioptric group for the 1
month and each 3 month visits up to and including the 12 month visit for
overnight wear should be provided.  The amount of  pre-treatment myopia
in a dioptric range, along with the current initial uncorrected VA would
address this point.
  Information should be presented statistically and in tabular form regarding
subjects whose pre-treatment best corrected visual acuity was reduced by
1, 2, or 2 or more lines post-treatment.
  An analysis of pre- and post-treatment best corrected visual acuity
stratified by diopter for subjects who completed all visits specified in the
protocol should be provided.
4.  Wearing Time and Stability:
Two main goals of orthokeratology are the reduction of refractive error and,
improved uncorrected visual acuity.  It would be helpful for practitioners of
orthokeratology to know what are the minimum and maximum wearing schedules
necessary in order to maintain the reduction in refractive error with subsequent
improvement in visual acuity that was achieved while undergoing
orthokeratology. The application should include:
  An analysis of the effects of wearing schedule on the maintenance of the
refractive and visual acuity outcomes.  This may be addressed by
following subjects are different time points during the day, or by
scheduling follow up visits at different times such as early morning or late
afternoon.
  The time necessary to return to baseline corneal and refractive
measurements is a topic that would be of interest to potential users. While
it may be impractical to ask successfully completed subjects to return
lenses and monitor the time it takes to return to baseline, it is highly
recommended that discontinued subjects be monitored for longer than the
initial exit visit to address this issue.
5.  Intraocular Pressure (IOP):
Applanation tonometry measurements of subjects IOP at baseline, mid-study
and final visit are recommended.  The value of IOP as a predicting variable of
orthokeratology success has been discussed in the literature.  By prospectively
Page 12 of 72 collecting these data the manufacturer would be able to determine if this factor
should be addressed in the patient selection portion of the product labeling.
G. Additional Considerations for Overnight Wear Studies (Prospective Investigations)
The element of overnight wear for the purposes of modification of refractive error
indicates the Premarket Approval (PMA) process is necessary. This is a new
indication (for ortho K ), using a currently approved extended wear contact lens
material.
To date there has not been a marketing approval by FDA for an extended wear RGP
lens for use in an overnight orthokeratology procedure.  The overnight wear of
contact lenses is considered a significant risk to subjects that requires an
Investigational Device Exemption (IDE) prior to initiating clinical study.
If the IDE is not submitted by the PMA holder, a letter from the PMA holder granting
FDA permission to reference the currently approved extended wear indication should
be provided in the IDE.  The PMA holder should acknowledge that they are aware the
referenced company plans to conduct a clinical study for a new indication.
Primary safety issues include whether the orthokeratology corneal molding presents
additional risk overnight when the cornea is hypoxic.  Also there is concern that the
rates of corneal abrasion may be increased with overnight use and that irregular
astigmatism may develop.
To address these additional safety issues, a study of 150 to 200 completed subjects
followed for a twelve-(12) month duration is recommended.
H. Retrospective Data
Retrospective data are useful to support the study design and some protocol issues
such as sample size, length of study, likely candidates, number of visits during
treatment, special subsets of patients, or statistical justifications for prospective
studies.  These data also serve as prior clinical experiences that are required by
regulation to be submitted in an application (IDE).
Prior experience may be helpful in determining the training requirements for
clinicians.  However, due to difficulties is addressing the consistency of data
collection practices across all study sites, the record sampling plan and the
mechanism utilized to minimize bias, FDA does not recommend the use of
retrospective clinical data to support a marketing application.
Page 13 of 72 I.  Recommended Orthokeratology Data Tables
Supplemental to standard contact lens data tables
KERATOMETRY CHANGES FROM BASELINE TO FINAL VISIT
The charts should be done by pre-treatment dioptric group for all completed eyes:
 Keratometry Change from Baseline to Final Visit
Pretreatment Myopia  (Spherical Diopters)
 1.0 D 1.25 to 2.25 to 3.25 to 4.25 to 5.25 to
2.00 D 3.00 D 4.00 D 5.0 D 6.00 D
K Reading Change n/% n/% N/% n/% n/% n/%
FLATTEN H V H V H V H V H V H V
0.00
0.12 to 0.50
0.62 to 1.00
1.12 to 1.50
1.62 to 2.00
    Etc.
STEEPER
0.00
0.12 to 0.50
0.62 to 1.00
1.12 to 1.50
    etc.
Corneal topography may substitute for keratometry.  Eccentricity values should be included if
available.
Page 14 of 72  ABSOLUTE CHANGE IN CORNEAL CYLINDER
 FROM BASELINE TO FINAL VISIT
 Corneal Cylinder Change from Baseline to Final Visit
Pretreatment Myopia  (Spherical Diopters)
 1.0 D 1.25 to 2.25 to 3.25 to Etc, Totals
2.00 D 3.00 D 4.00 D
Astigmatism Change n/% n/% n/% n/% n/%
0.00
Decreases
0.12 to 0.50
0.62 to 1.00
1.12 to 1.50
1.62 to 2.00
    Etc.
Increase
0.00
0.12 to 0.50
0.62 to 1.00
1.12 to 1.50
   Etc.
Page 15 of 72 DEMOGRAPHICS OF REFRACTIVE PARAMETERS
 Pretreatment Myopia  (Spherical Diopters)
Corneal  1.0 D 1.25 to 2.25 to 3.25 to Etc. Totals
Astigmatism 2.00 D 3.00 D 4.00 D
n/% n/% n/% n/% n/%
0.00
0.12 to 0.50
0.62 to 1.00
1.12 to 1.50
1.62 to 2.00
    Etc.
 CHANGE IN REFRACTIVE PARAMETERS
 Tables for completed eyes at the1 month and for every 3 month visit.
 Refractive Change from Baseline Visit
Pretreatment Myopia  (Spherical Diopters)
Refractive Change  1.0 D 1.25 to 2.25 to 3.25 to Etc. Totals
2.00 D 3.00 D 4.00 D
Decrease n/% n/% n/% n/%
0.00
0.12 to 0.50
0.62 to 1.00
1.12 to 1.50
1.62 to 2.00
    Etc.
Increase
0.00
0.12 to 0.50
0.62 to 1.00
1.12 to 1.50
1.62 to 2.00
    Etc.
Page 16 of 72    
ACCURACY OF INTENDED VS. ACHIEVED CORRECTION*
STRATIFIED BY DIOPTRIC GROUP
AT EACH 3 MONTH VISIT
Pretreatment Myopia  (Diopters)
MR  1.0 D 1.25 to 2.25 to ETC. Totals
2.00 D 3.00 D
n/N (%) n/N (%) n/N (%) n/N (%)
 0.50 D
 1.00 D
 2.00 D
Etc.
Not Reported
Total
Overcorrected
>+1
>+2
Etc.
Undercorrected
<-1
<-2
Etc.
Not reported
Total
Page 17 of 72 STABILITY OF MANIFEST REFRACTION*
STRATIFIED BY DIOPTRIC GROUP
Change in Pre-treat and 1 and  3 Months
Spherical 1 Month n/N (%) n/N (%)
Diopters
Pre-treatment myopia
 1.0 D 1.25 to 2.25 to ETC.  1.0 D 1.25 to 2.25 to ETC.
2.00 D 3.00 D 2.00 D 3.00 D
n/N (%) n/N (%) n/N (%) n/N (%) n/N (%) n/N (%)
 1.00 D
1.25 to
2.00D
2.25 to
3.00
Etc.
Mean
Difference
SD
95% CI
*This analysis should be performed only on subjects who were present at all visits
specified in the protocol.  It should be continued for each 3 month interval.
Page 18 of 72 REDUCTION IN MANIFEST REFRACTION AS A FUNCTION OF
 KERATOMETRY CHANGE (stratified by preoperative manifest refraction )
Reduction of Pretreatment Myopia  ( Spherical Diopters)
at each 3 month Visit
 Keratometry Change  1.0 D 1.25 to 2.25 to 3.25 to Etc. Totals
in Flat meridian 2.00 D 3.00 D 4.00 D
n/N (%) n/N (%) n/N (%) n/N %) n/N (%) n/N (%)
Flatten
0.12 to 0.50
0.62 to 1.00
1.12 to 1.50
1.62 to 2.00
Etc.
Steepen
0.12 to 0.50
0.62 to 1.00
1.12 to 1.50
1.62 to 2.00
* For all eyes minus those intentionally undercorrected
Page 19 of 72 UCVA  STRATIFIED BY PRE-TREATMENT
DIOPTRIC GROUP
Tables for 1 month and each 3 months.
x  Month
Pretreatment Myopia  (Spherical Diopters)
UCVA  1.0 D 1.25 to 2.25 to 3.25 to Etc. Totals
2.00 D 3.00 D 4.00 D
n/% n/% n/% n/% n/%
20/20 or better
20/25 or better
20/32 or better
20/40 or better
20/80 or better
20/200 or better
Not reported
Total
SUMMARY OF INTRAOCULAR PRESSURE
Initial Visit 3 Month Final
IOP n/N (%) n/N (%) N/N (%)
* Indicate method of measurement
Page 20 of 72 CHANGE IN BEST SPECTACLE CORRECTED
VISUAL ACUITY INITIAL TO FINAL
STRATIFIED BY PRETREATMENT DIOPTRIC GROUP
Pretreatment Myopia  (Diopters)
Change in VA  1.0 D 1.25 to 2.25 to 3.25 to  ETC. Total
2.00 D 3.00 D 4.00 D
n/% n/% n/% n/% n/% n/%
Decrease > 2 lines
Decrease 2 lines
Decrease 1 line
No change
Increase 1 line
Increase 2 lines
Increase >2 lines
Not reported
Total
DATALINE LISTINGS OF EYES WITH LOSS OF   2 LINES OF BSCVA
Pre-treatment 3 Month
Patient UCVA MR BSCVA UCVA MR BSCVA
code
Page 21 of 72 SUMMARY OF KEY SAFETY AND EFFICACY VARIABLES
1 Month 3 Month each 3 Months
n/N (%) n/N (%) n/N (%)
Efficacy Variables
UCVA 20/20 or better*
UCVA 20/40 or better*
Change in sphere      0.50D
Change in sphere      1.00D
Change in sphere      1.50D
Change in sphere      2.00D
Change in sphere      2.50D
Change in sphere      3.00D
Safety Variables
Loss of   2 lines BSCVA
BSCVA worse than 20/40
Increase > 1 D cylinder
BSCVA worse than 20/25 if
20/20 or better pre-treatment
For all eyes minus those intentionally undercorrected
WEAR TIME EFFECT ON UNCORRECTED
VISUAL ACUITY
Tables 1 month and every 3 months
Daily Wear time (hours)
UCVA 0 to 4 4.1 to 6 6.1 to 8 8.1 to 10 10.1 to Etc. Total
12.0
n/N (%) n/N (%) n/N (%) n/N (%) n/N (%) n/N (%)
20/15
20/20
20/30
20/40
20/50 to 60
 Etc.
Not reported
Total
Page 22 of 72 4.  SHIPPING CONTAINER LABEL
TRADE NAME  (generic name) RIGID GAS PERMEABLE CONTACT LENS FOR
ORTHOKERATOLOGY -[Daily Wear][Overnight Wear]
CONTENTS: One/Two contact lens(es)
CAUTION: Non-sterile.  Clean and condition lenses prior to use.
Base Curve:
Diameter:
Power:
Secondary Curve:
Color:
Center Thickness:
Lot Number:
CAUTION: Federal law prohibits dispensing without a prescription.
Applicants Name
Address
Page 23 of 72 5.  PACKAGE INSERT
TRADE NAME (generic name) RIGID GAS
PERMEABLE CONTACT LENSES FOR ORTHOKERATOLOGY - [Daily Wear][Overnight
Wear]
IMPORTANT:  Please read carefully and keep this information for future use.  This
package insert is intended for the eyecare practitioner, but should be made available to
patients upon request.  The eyecare practitioner should provide the patient with the
patient instructions that pertain to the patient's prescribed lens.
CAUTION:  Federal Law Prohibits Dispensing Without a Prescription.
WARNING:  Contains a [identify] compound which harms public health and
environment by destroying ozone in the upper atmosphere.  A notice similar to
the above Warning has been placed in the patient information of this
product, pursuant to EPA regulation.]
DESCRIPTION:
Trade Name (TN) Rigid Gas Permeable (RGP) contact lenses for [daily wear][overnight
wear] orthokeratology are lathe cut contact lenses with [spherical] or [aspherical] anterior
or posterior surfaces in clear [and tinted] version.  The posterior curve is selected so as to
property fit an individual eye for orthokeratology and the anterior curve selected to
provide the necessary optical power for a temporary reduction of myopia.  A peripheral
curve system on the posterior surface allows tear exchange between the lens and the
cornea.
TN contact lenses for orthokeratology are made from a [fluoro silicone acrylate][silicone
acrylate][etc] polymer, generic name, with a water content of less than [ ] percent.  [The
tinted lens contains [listed name of color additive] as a color additive.]  TN contact lenses
for orthokeratology are to be worn for [daily wear only] [daily wear or overnight wear].
LENS PARAMETERS AVAILABLE:
Chord Diameter
Center Thickness  for Low Minus Lens:
for Plus Lens:
Base Curve
Secondary Curves
   Flatter or steeper than Base Curve
Page 24 of 72 Peripheral Curves
Flatter or steeper than Base Curve
Powers
Aspheric Lens Eccentricity
    (Oblate, Prolate or Tangent Conic)
The physical properties of the lens are:
Refractive Index
Light Transmittance...
Wetting Angle
(Contact Receding Angle)
Specific Gravity
Hardness
Water Content
0xygen Permeability and method of measurement
ACTIONS:
TN contact lenses for orthokeratology produce a temporary reduction of myopia by
changing the shape (flattening) of the cornea, which is elastic in nature.  Flattening the
cornea reduces the focusing power of the eye, and if the amount of corneal flattening is
properly controlled, it is possible to bring the eye into correct focus and compensate for
myopia.  Contact lenses rest directly on the corneal tear layer and can influence the
corneal shape.  Regular contact lenses are designed to cause little or no effect but TN
contact lenses for orthokeratology are designed to purposely flatten the shape of the
cornea by applying slight pressure to the center of the cornea.  If the central cornea is
flattened this reduces the focusing power of the eye, and if the amount of corneal
flattening is sufficient, it is possible to bring the eye into correct focus and compensate
for myopia.  After the contact lens is removed, the cornea retains its altered shape for part
or all of the remainder of the day.  (A Myopic Reduction Maintenance Lens or Retainer
Lens should be worn each day to maintain the corneal flattening, or the myopia will
revert back to the pretreatment level.)
INDICATIONS (USES):
The TN (generic name) Rigid Gas Permeable orthokeratology contact lenses are
indicated for use in the reduction of myopic refractive error in non-diseased eyes.  The
lens is indicated for [daily wear][extended wear from X to X days between removal for
cleaning and disinfection as recommended by the eye care practitioner] in an
orthokeratology fitting program for the temporary reduction of myopia of up to X.00
diopters.  The lens may be disinfected using a chemical disinfection system only.
Note:  To maintain the orthokeratology effect of myopia reduction lens wear must be
continued on a prescribed wearing schedule.
Page 25 of 72 CONTRAINDICATIONS (REASONS NOT TO USE:
DO NOT USE YOUR TN  contact lenses when any of the following conditions
exist:
  Acute and subacute inflammations or infection of the anterior segment of the eye.
  Any eye disease, injury, or abnormality that affects the cornea, conjunctiva or
eyelids.
  Severe insufficiency of tears (dry eyes)
  Corneal hypoesthesia (reduced corneal sensitivity).
  Any systemic disease which may affect the eye or be exacerbated by wearing contact
lenses.
  Allergic reactions of ocular surfaces or adnexa which 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 your contact lenses.
  Any active corneal infection (bacterial, fungal or viral).
  If eyes become red or irritated.
WARNINGS:
Caution: TN contact lenses for orthokeratology are shipped to the practitioner non-sterile.
Clean and condition lenses prior to use.
Incorrect use of contact lenses and lens care products can result in serious injury to the
eye.    It  is  essential  to  follow  your  eyecare  practitioner's  directions  and  all  labeling
instructions for proper use of contact lenses and lens care products.  Eye problems,
including corneal ulcers, can develop rapidly and lead to loss of vision.  If you experience
eye discomfort, excessive tearing, vision changes, or redness of the eye, immediately
remove your lenses and do not wear them until you have been examined by your eye care
practitioner.  All contact lens wearers should see their eyecare practitioner according to
the schedule given to them.
TN contact lenses for orthokeratology [are to be worn on a daily wear basis only.  Do not
wear your
lenses while sleeping, at the risk of serious adverse reactions.][may be worn on an
overnight wear basis while sleeping as recommended by the eye care practitioner.]
Studies have shown that contact lens wearers who are smokers have a higher incidence of
adverse reactions than nonsmokers.
Page 26 of 72 PRECAUTIONS:
Specific Precautions
  Clinical studies have demonstrated that contact lenses manufactured from the TN
(generic name) rigid gas permeable lens materials are safe and effective for their
intended use.  However, the clinical studies may not have included all design
configurations or lens parameters that are presently available in the materials.
Consequently, when selecting an appropriate lens design and parameter the eyecare
practitioner should consider all factors that effect lens performance and ocular health.
The potential impact of these factors should be weighed against the patient's needs;
therefore, the continuing ocular health of the patient and lens performance on the eye
should be carefully monitored.
  Patients should be instructed to follow the instructions below in order to prevent
damage to their eyes or lenses.
Solution Precautions
  Different solutions cannot always be used together, and not all solutions are safe for
use with all lenses.  Use only recommended solutions with the contact lenses.
  Do not heat the wetting/soaking solution and lenses.
  Always use fresh unexpired lens care solutions.
  Always follow directions in the package inserts of the contact lens solutions used.
  Use only a chemical lens care system.  Use of a heat (thermal) lens care system can
cause damage by warping TN contact lenses.
  Sterile unpreserved solutions, when used, should be discarded after the time specified
in the labeling directions.
  Do not use saliva or anything other than the recommended solutions for lubricating or
wetting lenses.
  Always keep the lenses completely immersed in the recommended storage solution
when the lenses are not being worn (stored).
Handling Precautions
  Always wash and rinse hands before handling lenses.  Do not get cosmetics, lotions,
soaps, creams, deodorants, or sprays in the eyes or on the lenses.  It is best to put on
Page 27 of 72 lenses before putting on makeup.  Water-base cosmetics are less likely to damage
lenses than oil-base products.
  Be certain that your fingers or hands are free of foreign material before touching your
contact lenses, 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 information booklet and those prescribed by your
eyecare practitioner.
  Always handle your lenses carefully and avoid dropping them.
  Never use tweezers or other tools to remove your lenses from the lens container
unless specifically indicated for that use.  Pour your lens into your hand.
  Do not touch the lens with your fingernails.
  To minimize lens warpage during cleaning, the lenses should be cleaned in the palm
of the hand rather than between the thumb and fingers.
Lens Wearing Precautions
  If  the lens sticks (stops moving) on the eye, follow the recommended directions on
Care for a Sticking Lens in the patient information booklet.  The lens should move
freely on the eye for the continued health of the eye.  If nonmovement of the lens
continues, you should immediately consult your eyecare practitioner.
  Never wear your contact lenses beyond the period recommended by your eyecare
practitioner.
  Avoid, if possible, all harmful or irritating vapors and fumes when wearing lenses.
  If aerosol products such as sprays are used while wearing lenses, exercise caution and
keep eyes closed until the spray has settled.
Lens Case Precautions
  Contact lens cases can be a source of bacterial growth.  To prevent contamination and
to help avoid serious eye  injury, always empty and rinse the lens case with fresh,
sterile rinsing solution and allow to air dry.
  Lens cases should be replaced at regular intervals as recommended by the lens case
manufacturer or eyecare practitioner.
Page 28 of 72 Topics to Discuss with the Eyecare Practitioner
  Ask  your eyecare practitioner about wearing your lenses during sporting activities.
  Always contact your eyecare practitioner before using any medicine in your eyes.
  As with any contact lens, follow-up visits are necessary to assure the continuing
health of your eyes.  You should be instructed as to a recommended follow-up
schedule.
Who Should Know That the Patient is Wearing Contact Lenses
  Inform your doctor (health care practitioner) about being a contact lens wearer.
  Always inform your employer of being a contact lens wearer.  Some jobs may require
the use of eye protection equipment or may require that you not wear contact lenses.
ADVERSE EFFECTS  (PROBLEMS AND WHAT TO DO:  Patient's should be
informed that the following problems may occur:
  Eyes stinging, burning, itching (irritation), or other eye pain
  Comfort is less than when lens was first placed on eye.
  Feeling of something in the eye such as a foreign body or scratched area.
  Excessive watering (tearing) of the eyes
  Unusual eye secretions
  Redness of the eyes
  Reduced sharpness of vision (poor visual acuity)
  Blurred vision, rainbows, or halos around objects
  Sensitivity to light (photophobia)
If you notice any of the above: IMMEDIATELY REMOVE YOUR LENSES.  
If the discomfort or problem stops, then look closely at the lens.  If the lens is in any way
damaged, DO NOT put the lens back on your eye.  Place the lens in the storage case and
contact your eyecare practitioner.  If the lens has dirt, an eyelash, or other foreign objects
on it, or the problem stops and the lens appears undamaged, you should thoroughly clean,
rinse and disinfect the lens; then reinsert it.  If the problem continues, you should
IMMEDIATELY remove the contact lenses and consult your eyecare practitioner.
When any of the above problems occur, a serious condition such as infection, corneal
ulcer, neovascularization, or iritis may be present.  You should be instructed to keep the
lens off the eye and seek immediate professional identification of the problem and
prompt treatment to avoid serious eye damage.
Page 29 of 72 CLINICAL STUDY RESULTS:
A total of # (# patients) eyes were enrolled in the clinical study with # eyes (# patients)
completing a minimum of # months of contact lens wear.  Of the completed eyes a total
of # eyes showed some reduction in myopic refractive error during the #-month time
period that the TN contact lenses for orthokeratology were worn.  The average reduction
was # diopters with a range from X to X diopters.
The average amount of myopia that can be expected to be corrected is shown in the
following table.  These values are only averages and some patients can be expected to
achieve more or less than these averages.
AVERAGE REDUCTION IN MYOPIA (Diopters)
INITIAL       REDUCTION
Myopia       Myopia
-1.00 #
-2.00 #
-3.00 #
-4.00 #
Etc. #
The amount of myopia reduced varied between patients and could not be predicted prior
to treatment.  There was an insignificant difference between the patients who wore
contact lenses prior to the study and those with no previous contact lens experience.
TN contact lenses for orthokeratology provided a temporary full reduction in some
patients with up to # diopters of myopia.  For patients with greater than # diopters of
myopia only a partial reduction of myopia can be expected.  The percentage of patients
that can be expected to achieve full or partial temporary refractive reduction is shown in
the following table.
Page 30 of 72 PERCENT OF EYES THAT ACHIEVED FULL OR PARTIAL
 TEMPORARY REDUCTION OF MYOPIA
INITIAL  FULL   UP TO 0.50 D. FINAL V.A. FINAL V.A.
MYOPIA TEMPORARY UNDER FULL 20/20 or better 20/40 or better
REDUCTION REDUCTION
<1.00 D % % % %
-1.25 to
- 2.00 D.
-2.25 to
- 3.00 D.
-3.25 to
- 4.00 D.
Etc.
For the patients (# eyes) that completed this study, the initial visual acuity by best
refraction was 20/20 or better for # eyes and 20/40 or better for all eyes (#).  At the final
visit, visual acuity with contact lenses was equal to or better than 20/20 for # eyes, 20/40
for # eyes and # eyes had a visual acuity of 20/70. # eyes had a one-line drop in visual
acuity for contact lenses compared to best refraction, # eyes had a two-line drop and #
eyes had a three-line drop.  In each case the reduced visual acuity was attributed to[give
reason].
The percentage of eyes that achieved uncorrected visual acuity of 20/20 or better and
20/40 or better in relation to the initial myopia is given in the above table.  A total of #
(%) eyes achieved a visual acuity of 20/20 or better and # ( %) eyes achieved 20/40 or
better.
EFFECTS ON ASTIGMATISM
Either increases or decreases in astigmatism may occur following orthokeratology.  Of
the # eyes (# patients) which completed the three month clinical,  % showed no change in
corneal astigmatism,   % showed a decrease less than one diopter, while  % showed an
increase less than one diopter and  % showed an increase greater than one diopter.
WEARING TIME
The average wearing time required for patients who wore TN contact lenses for
orthokeratology for various time periods was as follows:
Page 31 of 72 One week       hours/days
Two weeks       hours/days
One month        hours/days
Three months       hours/days
[Etc. days]
There was considerable variability, however, as many patients required several hours
more or less than the averages as shown for the [three][twelve]-month time period as
follows:
Daily Wear
Time Worn Percent of patients
0 to 4 hours % 4.1 to 8 hours %
8.1 to 12 hours % 12.1 to 16 hours %
Overnight Wear
Time Worn Percent of Patients
1 to 3 days % 3 to 4 days %
4 to 5 days % 5 to 7 dyas %
FITTING:
Conventional methods of fitting rigid contact lenses for orthokeratology  DO NOT
APPLY to the TN contact lenses for orthokeratology.  For a description of fitting
techniques, refer to the Fitting Guide for TN contact lenses for orthokeratology, copies of
which are available from:
Applicants Name
Address
WEARING SCHEDULE:
Although many practitioners have developed their own initial wearing schedules, the
following sequence is recommended as a guideline.  Patients should be cautioned to
follow the wearing schedule recommended by the eyecare practitioner regardless of how
comfortable the lenses feel.
The following schedule depends upon the professional judgment of the eyecare
practitioner and should be modified according to the response to the initial lenses.
Page 32 of 72 Daily Wear
Maximum wearing time:
Day Wearing Time (Hours)
1 3
2 6
3 7
4 8
5 9
6 10
7 15
8 and after All hours awake
Overnight Wear
Maximum Wearing Time
[Patients  should  be  advised  NOT  TO  SLEEP  while  wearing  TN  contact  lenses  for
orthokeratology.    Studies  have  not  been  conducted  to  show  that  the  TN  rigid  gas
permeable contact lens is safe to wear during sleep.]  There is a tendency for some
patients to overwear the lenses initially.  It is important to remind patients to adhere to the
maximum wearing schedule above.  In order to maintain the orthokeratology effect of
myopia reduction lens wear should be continued on a wearing scheduled determined by
the eye care practitioner.  Refer to the Professional Fitting and Information Guide for
information on Myopic Reduction Maintenance Lens or Retainer Lens wear.
LENS CARE DIRECTIONS:
Patient should be advised to follow the directions contained in the package insert for the
Adjunct Solutions.  The Adjunct Solutions which were used with TN contact lenses for
orthokeratology are as follows:
Chemical Lens Care System
Clean
Rinse
Disinfect
Store
Lubricate/Rewet
Enzyme
*   is a trade mark of    [Solution manufacturer].
Page 33 of 72 The directions from the package inserts from these products should be followed.  Failure
to adhere to these procedures may result in the development of serious ocular
complications.  A patient should not switch from one care system to another unless it has
been determined by the eyecare practitioner that this is necessary.  Do not mix or
alternate the disinfection and storage systems unless so indicated on the product label.
Always wash and rinse your hands thoroughly before handling your contact lenses.
TN contact lenses for orthokeratology must be both cleaned, rinsed and disinfected each
time you remove them.  One procedure does not replace the other.  Cleaning is necessary
to remove mucus and film from the lens surface.  Disinfecting is necessary to destroy
harmful germs.  To minimize lens warpage during cleaning, the lenses should be cleaned
in the palm of the hand rather than between the thumb and fingers.
Clean one lens first. (The recommended procedure is to always clean the same lens first
to avoid mix-ups).  Rinse the lens thoroughly to remove the cleaning solution.  Place the
lens into the correct storage chamber and fill the chamber with the recommended
disinfection solution as recommended by your eyecare practitioner.
Tightly close the top of each chamber of the lens storage case.
To disinfect your lenses, leave them in the solution for at least the period of time
indicated on the product label.  Leave the lenses in the unopened storage case until you
are ready to put them in your eye.
LENS CASE CLEANING AND MAINTENANCE:
Contact lens cases can be a source of bacteria growth.  Lens cases should be emptied,
cleaned, rinsed with solutions recommended by the lens case manufacturer, and allowed
to air dry.  Lens cases should be replaced at regular intervals as recommended by the
eyecare practitioner.
ENZYME CLEANING:
Enzyme cleaning may be recommended by your eyecare practitioner.  Enzyme cleaning
does not replace routine cleaning and disinfecting.  You should carefully follow the
instructions in the enzymatic cleaning labeling.
EMERGENCIES:
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 then remove lenses promptly.
CONTACT THE EYECARE PRACTITIONER OR VISIT A HOSPITAL
EMERGENCY ROOM WITHOUT DELAY.
Page 34 of 72 HOW SUPPLIED:
Each lens  is supplied non-sterile in an individual plastic case.  The case, packing slip or
invoice is marked with the base curve, dioptic power, diameter, secondary curve, center
thickness, [color] and Lot #.
REPORTING OF ADVERSE REACTIONS:
All adverse reactions should be reported immediately to the manufacturer.  Telephone
xxx-xxx-xxxx or 800-yyy-yyyy.
(Printed month/Year)
Applicants Name and address
Page 35 of 72 6.  PATIENT INFORMATION BOOKLET (PART 1) FOR POTENTIAL USERS:
Trade Name (generic name)
RIGID GAS PERMEABLE CONTACT LENSES FOR ORTHOKERATOLOGY for [Daily
Wear][Overnight Wear]
CAUTION: Federal law prohibits dispensing without a prescription.
WARNING: Contains a [identify] compound which harms public health and
environment by destroying ozone in the upper atmosphere.
TABLE OF CONTENTS
Page
Glossary
Introduction
How the Eye Functions
How TN (generic name) Rigid Gas Permeable Contact Lenses
   for Orthokeratology Function
Alternative Ways To Correct Nearsightedness
Clinical Study Data
Maintaining Effects of TN Contact Lens for Orthokeratology
   Myopic Reduction Maintenance Lens or Retainer Lens Wear
Risk Analysis
Wearing Restrictions And Indications
Contraindications
Warnings
Page 36 of 72 GLOSSARY
Adnexa:   Tissues near the eye.
Adverse effects:  Undesirable effects.
Aphakia:  Eye that does not have a lens structure.
Astigmatism:  Eye condition in which one or more surfaces of the cornea or lens has a
shape that is not round but more like that of a spoon.
Contact Lens Sticking:   Lack of movement of a contact lens on the cornea.
Cornea:  The clear, bubble-like structure on the front of the eye, where light first enters
the eye.
Corneal abrasion:  Loss of cells on the corneal surface due to mechanical trauma.
Corneal edema:  Accumulation of fluid in the cornea.
Corneal hypoesthesia:  Partial loss of sensitivity to touch in the cornea.
Corneal staining:  Bright areas on the cornea where dye collects and which indicates an
abrasion or other disturbance of the cornea.
Corneal ulcer:  small area of tissue loss in the cornea.
Disinfection:  Destruction of bacteria and viruses but not some spores.
Diopter:  Unit of power for glasses or contact lenses.
Enzyming contact lenses:  Placing contact lenses in a solution that contains an enzyme
that dissolves proteins on the surface of the lens.
Hypoesthesia:  Reduced corneal sensitivity to touch.
Iritis:  Infection of the iris or colored portion of the eye.
Lacrimal secretion:  Tearing.
Myopia:  Medical term for nearsightedness.
Myopic Reduction Maintenance Lens: A modification of the orthokeratology contact lens
design in which the central portion of the lens applies just enough pressure to the
cornea to maintain the corneal flattening achieved but with no additional corneal
flattening.
Neovascularization:  New vessel growth in the cornea.
Orthokeratology:   Contact lens fitting procedure that temporarily reduces
nearsightedness after contact lenses have been removed.
Refract:  Bending of light in order to make it focus.
Refractive anomalies:  Eye conditions leading to blurred vision including
nearsightedness, farsightedness and astigmatism.
Retainer Lenses: Another name for the Myopic Reduction Maintenance Lens.
Retina:  Structure at the back of the eye that receives the light image.
Page 37 of 72 Rewetting contact lenses:  Placing a solution in the eye while contact lenses are worn that
acts as an artificial tear to wet the lens.
Sticking lens:  Lens on the cornea that does not move.
[Additions]
Page 38 of 72 INTRODUCTION
The information in this booklet is to help you decide whether or not to be fitted with the
TN contact lenses for orthokeratology.  Orthokeratology is a contact lens fitting
procedure that temporarily reduces nearsightedness (known by the medical name of
myopia) after contact lenses have been removed.  By temporary it is meant that the
contact lenses are worn for a portion of the [day] [night] and then removed, whereupon
the nearsightedness remains reduced for all or part of the remainder of the day.  The exact
time period over which the myopia remains reduced varies with each patient.  Generally,
TN contact lenses for orthokeratology should be worn for part of each day for the
orthokeratology effect to continue.
HOW THE EYE FUNCTIONS
The eye is very much like a camera and must be in good focus to see objects clearly.  The
focusing power of the eye comes from two eye structures, the cornea and the lens
[(Figure 1)].  The cornea is the clear, bubble-like structure on the front of the eye, where
light first enters the eye.  It provides about two thirds of the eye's focusing power, and the
lens inside the eye provides the other third.  In a normal eye light focuses at the retina, at
the back of the eye, which acts like the film in a camera.  Some eyes focus, or refract, the
light too much, so that the images of distant objects are formed in front of the retina, and
the image on the retina is blurred, producing myopia [(Figure 2)].
Myopia usually starts in childhood and gets progressively worse through adolescence.  It
normally stops increasing by the late teens, but it can sometimes continue to get worse
into the mid-twenties.
HOW TN CONTACT LENSES FOR ORTHOKERATOLOGY FUNCTION
TN contact lenses for orthokeratology produce a temporary reduction of nearsightedness
by changing the shape (flattening) of the cornea, which is elastic in nature.  Contact
lenses rest directly on the cornea, separated only by a layer of tears, and can influence the
corneal shape.  Regular contact lenses are designed to nearly match the shape of the
cornea and thereby cause little or no flattening effect but TN contact lenses for
orthokeratology are designed to purposely not match the shape of the cornea but instead
apply slight pressure to the center of the cornea [(Figure 3)], in a design known as reverse
geometry.  Pressure is produced when the lens is less curved than the cornea, which
places more of the lens weight on the center of the cornea.  If the cornea is flattened this
reduces the focusing power of the eye, and if the amount of corneal flattening is
sufficient, it is possible to bring the eye into correct focus and compensate for myopia
[(Figure 4)].  After the lens is removed, the cornea retains its altered shape for all or part
of the remainder of the day.
Page 39 of 72 Figure 1:  Normal Eye Figure 2:  Nearsighted eye
Figure 3:  Eye Fitted With TN contact lenses for orthokeratology.
Figure 4:  Nearsighted Eye After Orthokeratology
TN contact lenses for orthokeratology are indicated for patients who desire to have time
periods during the day in which they do not need to wear their contact lenses, but still be
able to see clearly.  This might include such activities as swimming and other sports.  TN
contact lenses for orthokeratology may be indicated in occupations that require exposure
to smoke, noxious gases or conditions of low humidity, such as might occur, for example,
Page 40 of 72 for flight attendants, in which case their contact lenses can be removed without
interference with vision.  Some patients are content to wear their contact lenses for
normal activities during part of the day and remove them for evening activities.
ALTERNATIVE WAYS TO CORRECT NEARSIGHTEDNESS
Nearsightedness (myopia) can be corrected by any method that reduces the focusing
power of the eye.  The most common methods of reduction are by glasses or regular
contact lenses.  These represent a means of correcting myopia only during the time that
the glasses or regular contact lenses are worn, with no lasting effect on the myopia. Other
methods of correcting myopia involve various surgical procedures.  These involve
techniques to reshape the cornea so that it is flattened in a way that is similar to that
produced by TN contact lenses for orthokeratology, except that the surgical procedures
are permanent.
CLINICAL STUDY DATA
TN contact lenses for orthokeratology may produce a temporary reduction of all or part
of your myopia.  The amount of reduction will depend on many factors, including the
amount of your initial myopia, the elastic characteristics of your eye and the way that
your contact lens fits on your eye.
[Summary example] A total of # (# patients) eyes were enrolled in a pre-marketing
clinical study.  Of those enrolled,  # eyes (# patients) completed a minimum of
[three][twelve] months of contact lens wear.  Of the completed eyes a total of # eyes
showed some reduction in myopic refractive error during the [3] [12]-month time period
that the TN contact lenses for orthokeratology were worn.  The average reduction was #
diopters with a range from # to # diopters.
The average amount of myopia that can be expected to be corrected is shown in the
following table.  These values are only averages and some patients can be expected to
achieve more or less than these averages.
AVERAGE REDUCTION IN MYOPIA (Diopters)
INITIAL REDUCTION
Myopia Myopia
-1.00 #
-2.00 #
-3.00 #
-4.00 #
Etc. #
Page 41 of 72 [Summary of data]
TN contact lenses for orthokeratology provided a temporary full reduction in some
patients with up to # diopters of myopia.  For patients with greater than # diopters of
myopia only a partial reduction of myopia can be expected.  The percentage of patients
that can be expected to achieve full or partial temporary refractive reduction is shown in
the following table.
PERCENT OF EYES THAT ACHIEVED FULL OR PARTIAL
 TEMPORARY REDUCTION OF MYOPIA
INITIAL  FULL   UP TO 0.50 D. FINAL V.A. FINAL V.A.
MYOPIA TEMPORARY UNDER FULL 20/20 or better 20/40 or better
REDUCTION REDUCTION
<1.00 D % % % %
-1.25 to
- 2.00 D. % % % %
-2.25 to
- 3.00 D. % % % %
-3.25 to
- 4.00 D. % % % %
Etc.
WEARING TIME
The average wearing time required for patients who wore the TN contact lenses for
orthokeratology was consistently about # [hours] [days] during the entire [three] [twelve]
month study.  The study [did] [did not] report how long the improved vision lasted once
lenses were removed. [On average improved vision lasted  about # hours.]
[Summarize the lens wearing time data.]
EFFECTS ON ASTIGMATISM
Either increases or decreases in astigmatism may occur following orthokeratology.  Of
the # eyes (# patients) which completed the [three] [twelve] month clinical study, #%
showed no change in corneal astigmatism, #% showed a decrease less than one diopter,
while #% showed an increase less than one diopter and #% showed an increase greater
than one diopter.
Page 42 of 72 MAINTAINING EFFECTS OF TN CONTACT LENSES FOR ORTHOKERATOLOGY -
    MYOPIC REDUCTION MAINTENANCE LENS OR RETAINER LENS WEAR
The long-term wear of TN contact lenses for orthokeratology does not eliminate the need
to continue wearing contact lenses to produce the orthokeratology effect.  After the
cornea has been flattened by wearing TN contact lenses for orthokeratology, new lenses
are prescribed that are Myopic Reduction Maintenance Lenses or Retainer Lenses.
Retainer Lenses are a modification of the patient's TN contact lens for orthokeratology
design in which the central portion of the lens applies just enough pressure to the cornea
to maintain the corneal flattening achieved but with no additional corneal flattening.  The
retainer lenses are generally worn for the same schedule as the TN contact lenses for
orthokeratology and should be worn each day to maintain the orthokeratology effect.
[Studies have not been conducted to support the safety of wearing TN contact lenses for
orthokeratology for overnight or extended wear.]
RISK ANALYSIS
There is a small risk involved when any contact lens is worn.  It is not expected that TN
contact lenses for orthokeratology will provide a risk that is greater than other rigid gas
permeable contact lenses.
The two most common side effects which occur in rigid contact lens wearers are corneal
edema and corneal staining.  It is anticipated that these two side effects will also occur in
some wearers of  TN contact lenses for orthokeratology.  Other side effects which
sometimes occur in all contact lens wearers are pain, redness, tearing, irritation,
discharge, abrasion of the eye or distortion of vision.  These are usually temporary
conditions if the contact lenses are removed promptly and professional care is obtained.
In rare instances, there may occur permanent corneal scarring, decreased vision,
infections of the eye, corneal ulcer, iritis, or neovascularization.  The occurrence of these
side effects should be minimized or completely eliminated if proper schedule of care is
followed.  You should remove your contact lenses if any abnormal signs are present.
Never wear your contact lenses while in the presence of noxious substances.  Be certain
to return for all follow-up visits required by your eyecare practitioner.
WEARING RESTRICTIONS AND INDICATIONS
INDICATIONS
TN contact lenses for orthokeratology are indicated for use in the reduction of myopic
refractive error in non-diseased eyes.  The lens is indicated for [daily wear][extended
wear from X to X days between removals for cleaning and disinfection as recommended
by the eye care practitioner] in an orthokeratology fitting program for the temporary
Page 43 of 72 reduction of myopia of up to # diopters.  The lens may be disinfected using a chemical
lens care system only.
Note:  To maintain the orthokeratology effect of myopia reduction, lens wear
should be continued on a prescribed wearing schedule.
[Do Not Wear Your Lenses While Sleeping.]
CONTRAINDICATIONS (REASONS NOT TO USE)
DO NOT USE YOUR TN contact lenses for orthokeratology when any of the
following conditions exist:
  Acute and subacute inflammations 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 tears (dry eyes)
  Corneal hypoesthesia (reduced corneal sensitivity) if not aphakic.
  Any systemic disease which may affect the eye or be exacerbated by wearing contact
lenses.
  Allergic reactions of ocular surfaces or adnexa which 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 your TN contact lenses for orthokeratology.
  Any active corneal infection (bacterial, fungal or viral).
  If eyes become red or irritated
WARNINGS:
You should be advised of the following warnings pertaining to contact lens wear:
[Daily wear lenses are NOT indicated for overnight wear, and you should not wear
lenses while sleeping.  Clinical studies have shown that the risk of serious adverse reactions
such as corneal infection or ulcers is increased when contact lenses are worn overnight.]
Problems with contact lenses and lens care products could result in serious injury to the eye.
It  is  essential  that  you  follow  your  eyecare  practitioner's  direction  and  all  labeling
instructions for proper use of lenses and lens care products, including the lens case.  Eye
problems, including corneal ulcers, can develop rapidly and lead to loss of vision.
Studies have shown that contact lens wearers who are smokers have a higher incidence of
adverse reactions than nonsmokers.
Page 44 of 72 If you experience eye discomfort, excessive tearing, vision changes, or redness of the eye
you should immediately remove your lenses and promptly contact your eyecare
practitioner.
Page 45 of 72 7.  PATIENT INSTRUCTIONS (PART 2) AFTER YOUR TN (generic name)
RIGID GAS PERMEABLE CONTACT LENSES FOR
ORTHOKERATOLOGY  HAVE BEEN FITTED
CAUTION: Federal law prohibits dispensing without a prescription.
WARNING: Contains a [identify] compound which harms public health and
environment by destroying ozone in the upper atmosphere.
TABLE OF CONTENTS
Page
Precautions
Adverse Effects
Personal Cleanliness And Lens Handling
    Preparing The Lens For Wearing
    Handling The Lenses
    Placing The Lens On The Eye
    Centering The Lens
    Removing The Lens
Caring For Your Lenses (Cleaning, Rinsing, Disinfecting, Enzyming,
    Storage And Rewetting/Lubricating)
    Basic Instructions
    Lens Deposits And Use Of Enzymatic Cleaning Procedures
    Care For A Sticking (Nonmoving) Lens
    Emergencies
    Wearing and Appointment Schedules
Page 46 of 72 PRECAUTIONS:
Specific Precautions
  Clinical studies have demonstrated that contact lenses manufactured from the TN
(generic name) rigid gas permeable lens materials are safe and effective for their
intended use.  However, the clinical studies may not have included all design
configurations or lens parameters that are presently available in the materials.
Consequently, when selecting an appropriate lens design and parameter the eyecare
practitioner should consider all factors that effect lens performance and ocular health.
The potential impact of these factors should be weighed against the patient's needs;
therefore, the continuing ocular health of the patient and lens performance on the eye
should be carefully monitored.
  Patients should be instructed to follow the instructions below in order to prevent
damage to their eyes or lenses.
Solution Precautions
  Different solutions cannot always be used together, and not all solutions are safe for
use with all lenses.  Use only recommended solutions with the contact lenses.
  Do not heat the wetting/soaking solution and lenses.
  Always use fresh unexpired lens care solutions.
  Always follow directions in the package inserts of the contact lens solutions used.
  Use only a chemical lens care system.  Use of a heat (thermal) lens care system can
cause damage by warping TN contact lenses.
  Sterile unpreserved solutions, when used, should be discarded after the time specified
in the labeling directions.
  Do not use saliva or anything other than the recommended solutions for lubricating or
wetting lenses.
  Always keep the lenses completely immersed in the recommended storage solution
when the lenses are not being worn (stored).
Page 47 of 72 Handling Precautions
  Always wash and rinse hands before handling lenses.  Do not get cosmetics, lotions,
soaps, creams, deodorants, or sprays in the eyes or on the lenses.  It is best to put on
lenses before putting on makeup.  Water-base cosmetics are less likely to damage
lenses than oil-base products.
  Be certain that your fingers or hands are free of foreign material before touching your
contact lenses, 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 this booklet and those prescribed by your eyecare practitioner.
  Always handle your lenses carefully and avoid dropping them.
  Never use tweezers or other tools to remove your lenses from the lens container
unless specifically indicated for that use.  Pour your lens into your hand.
  Do not touch the lens with your fingernails.
  To minimize lens warpage during cleaning, the lenses should be cleaned in the palm
of the hand rather than between the thumb and fingers.
Lens Wearing Precautions
  If  the lens sticks (stops moving) on the eye, follow the recommended directions on
Care for a Sticking Lens in this booklet.  The lens should move freely on the eye for
the continued health of the eye.  If nonmovement of the lens continues, you should
immediately consult your eyecare practitioner.
  Never wear your contact lenses beyond the period recommended by your eyecare
practitioner.
  Avoid, if possible, all harmful or irritating vapors and fumes when wearing lenses.
  If aerosol products such as sprays are used while wearing lenses, exercise caution and
keep eyes closed until the spray has settled.
Page 48 of 72 Lens Case Precautions
  Contact lens cases can be a source of bacterial growth.  To prevent contamination and
to help avoid serious eye  injury, always empty and rinse the lens case with fresh,
sterile rinsing solution and allow to air dry.
  Lens cases should be replaced at regular intervals as recommended by the lens case
manufacturer or eyecare practitioner.
Topics to Discuss with the Eyecare Practitioner
  Ask  your eyecare practitioner about wearing your lenses during sporting activities.
  Always contact your eyecare practitioner before using any medicine in your eyes.
  As with any contact lens, follow-up visits are necessary to assure the continuing
health of your eyes.  You should be instructed as to a recommended follow-up
schedule.
Who Should Know That the Patient is Wearing Contact Lenses
  Inform your doctor (health care practitioner) about being a contact lens wearer.
  Always inform your employer of being a contact lens wearer.  Some jobs may require
the use of eye protection equipment or may require that you not wear contact lenses.
ADVERSE EFFECTS:
You should be informed that the following problems may occur:
  Eyes stinging, burning, itching (irritation), or other eye pain
  Comfort is less than when lens was first placed on eye.
  Feeling of something in the eye such as a foreign body or scratched area.
  Excessive watering (tearing) of the eyes
  Unusual eye secretions
  Redness of the eyes
  Reduced sharpness of vision (poor visual acuity)
  Blurred vision, rainbows, or halos around objects
  Sensitivity to light (photophobia)
  Dry eyes
Page 49 of 72 If you notice any of the above, IMMEDIATELY REMOVE YOUR LENSES.
If the discomfort or problem stops, then look closely at the lens.  If the lens is in any way
damaged, DO NOT put the lens back on your eye.  Place the lens in the storage case and
contact your eyecare practitioner.  If the lens has dirt, an eyelash, or other foreign objects on
it, or the problem stops and the lens appears undamaged, you should thoroughly clean, rinse
and  disinfect  the  lens;  then  reinsert  it.    If  the  problem  continues,  you  should
IMMEDIATELY remove the contact lenses and consult your eyecare practitioner.
When any of the above problems occur, a serious condition such as infection, corneal ulcer,
neovascularization, or iritis may be present.  You should be instructed to keep the lens off
the eye and seek immediate professional identification of the problem and prompt treatment
to avoid serious eye damage.
PERSONAL CLEANLINESS FOR LENS HANDLING:
1.  Preparing the Lens for Wearing:
It is essential that you learn and use good hygienic methods in the care and
handling of your new lenses.  Cleanliness is the first and most important aspect of
proper contact lens care.  In particular, your hands should be clean and free of any
foreign substance when you handle your lenses.  The procedures are:
Always wash your hands thoroughly with a mild soap, rinse completely, and dry
with a lint-free towel before touching your lenses.
Avoid the use of soaps containing cold cream, lotion, or oily cosmetics before
handling your lenses, since these substances may come into contact with the
lenses and interfere with successful wearing.
To avoid damaging your lenses, handle them with your fingertips, and be careful
to avoid contact with your fingernails.  It is helpful to keep your fingernails short
and smooth.
Start off correctly by getting into the habit of always using proper hygienic
procedures so that they become automatic.
2.  Handling the Lenses:
Develop the habit of always working with the same lens first to avoid mix-ups.
Remove the lens from its storage case and examine it to be sure that it is moist,
clean, clear, and free of any nicks and tears.
Page 50 of 72 3.  Placing the Lens on the Eye:
Work over a table, upon which is placed a clean towel.
Do not place lenses on the eye while working over a sink.
For the right eye:
Wet the forefinger of the right hand and place the contact lens on the forefinger of
the right hand.
Place the second finger of the left hand on the middle of the upper lid and press
upward firmly.
Place the second finger of the right hand on the lower lid and press downward
firmly.
Stare into a mirror as though looking through the second finger holding the
contact lens.  You will later learn to do this without a mirror.
Slowly move the hand to advance the forefinger with the contact lens towards the
cornea until the lens touches the cornea and release the lids.
Release the lid and close the eye for a few seconds.
Repeat for the left eye.
There are other methods of lens placement.  If the above method is difficult for
you, your eyecare practitioner will provide you with an alternate method.
Note: If after placement of the lens your vision is blurred, check for the following:
The lens is not centered on the eye (see "Centering the Lens", next section in this
booklet).
If the lens is centered, remove the lens (see "Removing the Lens" section) and check for
the following:
a.  Cosmetics or oils on the lens.  Clean, rinse, disinfect, and place on the eye again.
b.  The lens is on the wrong eye.
If you find that your vision is still blurred after checking the above possibilities, remove
both lenses and consult your eyecare practitioner.
Page 51 of 72 4.  Centering the Lens:
Very rarely, a lens that is on the cornea will be displaced onto the white part of
the eye during lens wear.  This can also occur during placement and removal of
the lenses if the correct techniques are not performed properly.  To center a lens
follow the procedure below.
First locate the lens by pulling away the lids.  After the lens is found, gently press
on the lid over the lens while looking away from the direction of the lens.  Next
look back towards the lens.
5.  Removing the Lens:
Always remove the same lens first.
a.  Wash, rinse, and dry your hands thoroughly.
b.  Work over a table with a clean towel.  Do not remove lenses over a sink.
Place the right index finger of the right hand at the outer corner of the eye.
Place the left hand cupped below the eye.  Open the eyes wide as if to stare.
Continue to keep the eyes open and pull the lids sideways away from nose.
Blink quickly and firmly.
c.  Remove the other lens by following the same procedure.
d.  Follow the required lens care procedures described under the heading
CARING FOR YOUR LENSES (CLEANING, RINSING,
DISINFECTING, ENZYMING, STORAGE AND
REWETTING/LUBRICATING).
Note: If this method of removing your lens is difficult for you, your eyecare practitioner
will provide you with an alternate method.
CARING FOR YOUR LENSES (CLEANING, RINSING, DISINFECTING,
ENZYMING, STORAGE, AND REWETTING/LUBRICATING):
1.  Basic Instructions:
For continued safe and comfortable wearing of your lenses, it is important that
you clean and rinse, then disinfect your lenses after each removal using the care
regimen recommended by your eyecare practitioner.  Cleaning and rinsing are
necessary to remove mucus, secretions, films, or deposits that may have
accumulated during wearing.  The ideal time to clean, rinse, and disinfect your
Page 52 of 72 lenses is immediately after wearing them.  Disinfecting is necessary to destroy
harmful germs.
You should adhere to a recommended care regimen.  Failure to follow the
regimen may result in development of serious ocular complications as discussed
in the WARNINGS section above.
When you first receive your lenses, practice how to put the lenses on and
removing them while you are in your eyecare practitioners office.  At that time
you will be provided with a recommended cleaning and disinfection regimen and
instructions and warnings for lens care, handling, cleaning, and disinfection.
Your eyecare practitioner should instruct you about appropriate and adequate
procedures and products for your use.
For safe contact lens wear, you should know and always practice your lens care
routine:
  Always wash, rinse, and dry hands before handling contact lenses.
  Always use fresh unexpired lens care solutions.
Use the recommended system of lens care, which is chemical (not heat) and
carefully follow instructions on solution labeling.  Different solutions cannot
always be used together, and not all solutions are safe for use with all lenses.  Do
not alternate or mix lens care systems unless indicated on solution labeling.
Always remove, clean, rinse, enzyme and disinfect your lenses according to the
schedule prescribed by your eyecare practitioner.  The use of an enzyme or any
cleaning solution does not substitute for disinfection.
To avoid contamination, do not use saliva or anything other than the
recommended solutions for lubricating or rewetting your lenses.  Do not put
lenses in your mouth.
The lens care products listed below are recommended by Applicants name for use
with your TN orthokeratology contact lenses.
Chemical Lens Care System
Clean
Rinse
Disinfect
Store
Lubricate/Rewet
Enzyme
*    is a trade mark of company.
Page 53 of 72 Note: Some solutions may have more than one function, which will be indicated on the
label.  Read the label on the solution bottle, and follow instructions.
a.  Clean
Clean one lens first (always start with the same lens first to avoid mix-ups).  Place
the lens, front side down, in the palm of the hand and apply several drops of
cleaning solution.  Using the index finger of the other hand, apply slight pressure
in a swirling motion for about X seconds.  Do not clean the lens by rubbing it
between the thumb and index fingers, as this may cause lens warpage.
b.  Rinse
Rinse the lens thoroughly with clean tap water or saline to remove the cleaning
solution, mucus, and film from the lens surface.  Place that lens into the correct
chamber of the lens storage case.  Then repeat the procedure for the second lens.
c.  Disinfect
After cleaning and rinsing the lenses disinfect them by using the system
recommended by your eyecare practitioner and/or the lens manufacturer.  Follow
the instructions provided in the disinfection solution labeling.
d.  Storage
To store lenses, disinfect and leave them in the closed case until ready to wear.  If
lenses are not to be used immediately following disinfection, you should consult
the storage solution package insert or your eyecare practitioner for information on
storage of your lenses.
Always keep your lenses completely immersed in a recommended
disinfecting/conditioning solution when the lenses are not being worn.  If you
discontinue wearing your lenses, but plan to begin wearing them again after a few
weeks, ask your eyecare practitioner for a recommendation on how to store your
lenses.
Note:  TN contact lenses for orthokeratology cannot be heat (thermally) disinfected.
e.  Care of Your Lens Case
Contact lens cases can be a source of bacteria growth.  After removing your
lenses from the lens case, empty and rinse the lens storage case with solution(s)
recommended by the lens case manufacturer; then allow the lens case to air dry.
When the case is used again, refill it with fresh disinfecting solution.  Lens cases
Page 54 of 72 should be replaced at regular intervals as recommended by the lens case
manufacturer or your eyecare practitioner.
f.  Lubricating/Rewetting
Your eyecare practitioner will recommend a lubricating/rewetting solution for
your use.  Lubricating/Rewetting solutions can be used to rewet (lubricate) your
lenses while you are wearing them to make them more comfortable.
2.  LENS DEPOSITS AND USE OF ENZYMATIC CLEANING
PROCEDURE:
Enzyme cleaning may be recommended by your eyecare practitioner.  Enzyme
cleaning removes protein deposits on the lens.  These deposits cannot be removed
with regular cleaners.  Removing protein deposits is important for the well-being
of your lenses and eyes.  If these deposits are not removed, they can damage the
lenses and cause irritation.
Enzyme cleaning does not replace routine cleaning and disinfecting.  For enzyme
cleaning, you should carefully follow the instructions in the enzymatic cleaning
labeling.
3.  CARE FOR A STICKING (NONMOVING) LENS:
If the lens sticks (stops moving) or cannot be removed, you should apply 5 drops
of the 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 non-
movement of the lens continues after 30 minutes, you should IMMEDIATELY
consult your eyecare practitioner.
4.  EMERGENCIES:
If chemicals of any kind (household products, gardening solutions, laboratory
chemicals, etc.) are splashed into your eyes, you should: FLUSH EYES
IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONTACT
YOUR EYECARE PRACTITIONER OR VISIT A HOSPITAL EMERGENCY
ROOM WITHOUT DELAY.
Page 55 of 72 5. WEARING AND APPOINTMENT SCHEDULES:
Prescribed Wearing Schedule
Daily Wear
Day                   Wearing Time (Hours)
1
2
3
4
5
6
7
8
9
10
11
12
( IF APPLICABLE  Overnight Wear)
PATIENT/EYECARE PRACTITIONER INFORMATION:
Name
Address
Phone Number
Emergency Phone Number
MANUFACTURER
Name
Address
Phone
PRINTING DATE
Page 56 of 72 8.  PROFESSIONAL FITTING AND INFORMATION GUIDE FOR
TRADE NAME  (generic name) RIGID GAS PERMEABLE CONTACT LENSES FOR
ORTHOKERATOLOGY
CAUTION: Federal Law Prohibits Dispensing Without a Prescription.
[WARNING: Contains a [identify] compound which harms public health and
environment by destroying ozone in the upper atmosphere.  A notice similar to the
above Warning has been placed in the patient information of this product,
pursuant to EPA regulation.]
TABLE OF CONTENTS
Page
Introduction
Product Description
Lens Parameters Available
Actions
Indications
Contraindications, Warnings, and Adverse Reactions
Precautions
Selection of patients
Fitting Procedure
Orthokeratology Lens Description
Predicting Lens Results
Clinical Study Results
Myopic Reduction Maintenance Lens or Retainer Lens Wear
Risk Analysis
Fitting TN Contact Lenses for Orthokeratology
Pre-fitting Examination
Initial Lens Power Selection
Initial Lens Diameter Selection
Initial Lens Base Curve Selection
Initial Lens Evaluation
Trial Lenses
Follow-Up Care
Ortho-K problem solving
Recommended Initial Wearing Schedule
Handling of Lenses
Patient Lens Care Directions
Vertex Distance and Keratometry Conversion Charts
Reporting of Adverse Reactions
How Supplied
Package Insert
Page 57 of 72 INTRODUCTION:
Trade Name contact lenses for orthokeratology are made from a [fluoro silicone acrylate]
[silicone acrylate] [etc.] polymer with a water content of  # percent.  The lenses are to be worn
for [daily wear only.] [overnight wear from one to # days between cleaning and disinfection as
recommended by the eye care practitioner.]
PRODUCT DESCRIPTION:
The TN contact lens for orthokeratology is a rigid gas permeable contact lens in a reverse
geometry design.  The lens material, [generic name], is a [fluoro silicone acrylate] [silicone
acrylate] [etc.] polymer which contains [listed color additive] as a color additive.  The TN
contact lens for orthokeratology has the following dimensions:
LENS PARAMETERS AVAILABLE:
Chord Diameter
Center Thickness
for Low Minus Lens:
for Plus Lens:
Base Curve
Secondary Curves
Flatter or Steeper than Base Curve
Peripheral Curves
Flatter or Steeper than Base Curve
Powers
Aspheric Lens Eccentricity
(Oblate, Prolate or Tangent Conic)
The physical properties of the lens are:
Refractive Index
Light Transmittance
Wetting Angle
(Contact Receding Angle)
Specific Gravity
Hardness
Water Content
Oxygen Permeability and method
Page 58 of 72 ACTIONS:
TN contact lenses for orthokeratology produce a temporary reduction of myopia by changing the
shape (flattening) of the cornea, which is elastic in nature.  Flattening the cornea reduces the
focusing power of the eye, and if the amount of corneal flattening is properly controlled, it is
possible to bring the eye into correct focus and compensate for myopia.  Contact lenses rest
directly on the corneal tear layer and can influence the corneal shape.  Regular contact lenses are
designed to cause little or no effect but TN contact lenses for orthokeratology are designed to
purposely flatten the shape of the cornea by applying slight pressure to the center of the cornea.
If the cornea is flattened this reduces the focusing power of the eye, and if the amount of corneal
flattening is sufficient, it is possible to bring the eye into correct focus and compensate for
myopia.  After the contact lens is removed, the cornea retains its altered shape for part or all of
the remainder of the day.  A myopic reduction maintenance lens or retainer lens must be worn
each day to maintain the corneal flattening, or the myopia will revert back to the pre-treatment
level.
INDICATIONS (USES):
The TN (generic name) Rigid Gas Permeable Contact Lenses for orthokeratology are indicated
for use in the reduction of myopic refractive error in non-diseased eyes.  The lens is indicated for
[daily wear] [extended wear from 1 to # days between removals for cleaning and disinfection as
recommended by the eye care practitioner] in an orthokeratology fitting program for the
temporary reduction of myopia of up to # diopters.  The lenses may be disinfected using a
chemical disinfection system only.
Note: To maintain the orthokeratology effect of myopia reduction lens wear must be continued
on a prescribed wearing schedule.
CONTRAINDICATIONS (REASONS NOT TO USE) WARNINGS AND ADVERSE
REACTIONS:
DO NOT USE TN contact lenses for orthokeratology when any of the following conditions exist:
  Acute and subacute inflammations or infection of the anterior segment of the eye.
  Any eye disease, injury, or abnormality that affects the cornea, conjunctiva or eyelids.
  Severe insufficiency of tears (dry eyes)
  Corneal hypoesthesia (reduced corneal sensitivity).
  Any systemic disease which may affect the eye or be exacerbated by wearing contact lenses.
  Allergic reactions of ocular surfaces or adnexa which 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 contact lenses.
  Any active corneal infection (bacterial, fungal or viral).
  If eyes become red or irritated.
Page 59 of 72 Caution: TN contact lenses for orthokeratology are shipped to the
practitioner non-sterile.  Clean and condition lenses prior to use.
PRECAUTIONS:
Clinical studies have demonstrated that contact lenses manufactured from the TN contact lens for
orthokeratology materials are safe and effective for their intended use.  However, 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 were not evaluated in significant
numbers.  Consequently, when selecting an appropriate lens design and parameters, the eye care
practitioner should consider all characteristics of the lens that can affect lens performance and
ocular health, including oxygen permeability, wettability, central and peripheral thickness, and
optic zone diameter.
The potential impact of these factors on the patient's ocular health should be carefully weighed
against the patient's need for refractive reduction; therefore, the continuing ocular health of the
patient and lens performance on the eye should be carefully monitored by the prescribing eye
care practitioner.
SELECTION OF PATIENTS:
Patients are selected who have a demonstrated need and desire for a refractive reduction by
orthokeratology with rigid gas permeable contact lenses and who do not have any of the
contraindications for contact lenses described above.  TN contact lenses for orthokeratology are
indicated for myopic patients who desire to have time periods during the day, in which they do
not need to wear their contact lenses, but still be able to see clearly.  This might include such
activities as swimming and other sports.  TN contact lenses for orthokeratology may be useful in
occupations that require exposure to smoke, noxious gases or conditions of low humidity, such
as would be the case for flight attendants, if their lenses can be worn before exposure to the
noxious substance and removed during its presence.  Some patients are content to wear their
contact lenses for normal activities during part of the day and remove them for evening activities.
TN contact lenses for orthokeratology are primarily intended for patients who are within the
following parameters.
Refractive error: # to # diopters
Keratometry # to # diopters;
Visual Acuity 20/# to 20/#
FITTING PROCEDURE:
TN contact lenses for orthokeratology are designed to be fitted so as to flatten the central cornea
and thereby reduce myopia.  This goal is accomplished by the lens design and the manner in
which the lens is fitted.
Page 60 of 72 TN Lens Description
The TN contact lens for orthokeratology  has a design known as reverse geometry.  This means
that the secondary curve on the posterior surface has a radius of curvature that is steeper (shorter
radius) than the base curve (central curve).  The secondary curve is surrounded by a flatter
peripheral curve near the edge [(Figure 1)].  In this way the geometry of the secondary curve is
in the opposite relationship to the base curve, as occurs with standard rigid gas permeable contact
lenses.
The function of the steep secondary curve in the TN contact lens for orthokeratology is to allow
the base curve to be fitted flat in relation to the central cornea and still maintain lens stability on
the cornea.  With a regular contact lens design, that is fitted flat on the cornea, there is only one
support point for the contact lens, which occurs at the center of the lens.  This lens will tend to
rock and decenter on the cornea.  With the TN contact lens for orthokeratology there is support
for the lens at both the central cornea and also in the area of the secondary curve.  This will tend
to reduce lens rocking and aid in centering.
The most commonly used lens design for the TN contact lens for orthokeratology  has a
secondary curve that is [#]diopters, steeper (higher power) than the base curve.  The peripheral
curve is a standard flatter curve.  The secondary curve relationship can be altered to achieve an
optimal lens design for each patient.  Normally the secondary curve is between # and # diopters
steeper than the base curve.  In some lenses the secondary curve is divided into two curves of
nearly equal width.  The inner portion of the secondary curve is equivalent to the usual radius
value of the TN lens and the outer portion is flattened to provide a smooth transition to the
peripheral curve, in the manner of a blend.
Predicting Lens Results
Various methods have been proposed for predicting the amount of corneal flattening that may be
achieved for a given patient by orthokeratology.  There is some evidence that patients with
corneas of higher eccentricities are more likely to undergo greater amounts of corneal flattening
than do patients with more spherical corneas.  Corneal eccentricity can be measured by video
keratography or by comparing central and peripheral keratometry readings.  Other studies have
not supported these conclusions, however, and further research is needed.  It is not possible at
this time to predict which patients will achieve the greatest corneal flattening with TN contact
lenses for orthokeratology.
TN contact lenses for orthokeratology may produce a temporary reduction of all or part of a
patient's myopia.  The amount of reduction will depend on many factors including the amount of
myopia, the elastic characteristics of the eye and the way that the contact lenses are fitted.
Average amounts of reduction have been established by clinical studies but the reduction for an
individual patient may vary significantly from the averages.
Page 61 of 72 CLINICAL STUDY RESULTS:
A total of # (# patients) eyes were enrolled in the clinical study with # eyes (# patients)
completing a minimum of [three] [twelve] months of contact lens wear.  Of the completed eyes a
total of # eyes showed some reduction in myopic refractive error during the [3][12]-month time
period that the  TN contact lenses for orthokeratology were worn.  This included:
  # eyes (#%) had a reduction of between 0.25 and 1.00 D,
  # eyes (#%) between 1.25 and 2.00 D,
  # eyes (#%) between 2.25 and 3.00 D,
  # eyes (#%) between 3.25 and 4.00 D and,
  # eye (# %) reduced by 4.25 D
Other clinical refractive outcomes:
  # eyes had no change and # eyes increased in minus power by 0.25D.
  The reduction in myopia was [greater][less] for eyes with a higher initial refractive error.
  # eyes over -3.50D were able to achieve a full reduction in myopia.
  For # eyes with an initial myopia of greater than 3.75D the average final exam reduction in
myopia was [#D].
  The limit in initial myopia that could be reduced to emmetropia in was [#D].
The average amount of myopia that can be expected to be corrected is shown in the following
table.  These values are only averages and some patients can be expected to achieve more or less
than these averages.
AVERAGE REDUCTION IN MYOPIA (Diopters)
INITIAL     REDUCTION
Myopia    Myopia
-1.00 #
-2.00 #
-3.00 #
-4.00 #
Etc. #
The average reduction was # diopters with a range from # to # diopters.  The amount of myopia
reduced varied between patients and could not be predicted prior to treatment.  There [was] [was
Page 62 of 72 not] an insignificant difference between the patients who wore contact lenses prior to the study
and those with no previous contact lens experience.
TN contact lenses for orthokeratology provided a temporary full reduction in some patients with
up to # diopters of myopia.  For patients with greater than # diopters of myopia only a partial
reduction of myopia can be expected.  The percentage of patients that can be expected to achieve
full or partial temporary refractive reduction is shown in the following table:
PERCENT OF EYES THAT ACHIEVED FULL OR PARTIAL
 TEMPORARY REDUCTION OF MYOPIA
INITIAL  FULL   UP TO 0.50 D. FINAL V.A. FINAL V.A.
MYOPIA TEMPORARY UNDER FULL 20/20 or better 20/40 or better
REDUCTION REDUCTION
<1.00 D % % % %
-1.25 to
- 2.00 D. % % % %
-2.25 to
- 3.00 D. % % % %
-3.25 to
- 4.00 D. % % % %
Etc.       % %          % %
For the patients (# eyes) that completed the study, the initial visual acuity by best refraction was
20/20 or better for # eyes and 20/40 or better for # eyes. At the final visit, visual acuity with
contact lenses was equal to or better than 20/20 for # eyes, 20/40 for # eyes and # eyes had a
visual acuity of 20/[#].  # eyes had a one-line drop in visual acuity for contact lenses compared to
best refraction, # eyes had a two-line drop and # eyes had a three-line drop.
The percentage of eyes that achieved uncorrected visual acuity of 20/20 or better and 20/40 or
better in relation to the initial myopia is given in the above table.  A total of  # (#%) eyes
achieved a visual acuity of 20/20 or better and # (# %) eyes achieved 20/40 or better.
EFFECTS ON ASTIGMATISM
Either increases or decreases in astigmatism may occur following orthokeratology.  Of the # eyes
(# patients) which completed the [three][twelve] month clinical study, #% showed no change in
corneal astigmatism, #% showed a decrease less than one diopter, while # % showed an increase
less than one diopter and #% showed an increase greater than one diopter.
Page 63 of 72 The following changes were noted:
Decrease
 from 0.12 to l.00 D was observed for #eyes (#%)
 from l.12 to l.50 D for #eyes (#%)
 more than 1.50 D for # eyes (#%)
Increase
 from 0. 1 2 to 1.00 D was observed for # eyes (# %)
from 1. 1 2 to 2.00 D for # eyes (#%)
 from 2.12 to 3.00 D for # eyes (# %)
 from 3.12 to 3.50 D for # eyes (# %)
          more than 3.50D for # eyes (#%)
WEARING TIME
The average wearing time required for patients who wore TN contact lenses for orthokeratology
for various time periods was as follows:
One week  hours/days
Two weeks  hours/days
One month  hours/days
Three months  hours/days
Etc.  hours/days
There was considerable variability, however, as many patients required several [hours][days]
more or less than the averages as shown for the [three][twelve]-month time period as follows:
Daily Wear
Time Worn Percent of patients
0 to 4 hours                          #%   4.1 to 8 hours #%
8.1 to 12 hours                     #% 12.1 to 16 hours #%
Overnight Wear
1 to 3 days
Ec.
MYOPIC REDUCTION MAINTENANCE LENS OR RETAINER LENS WEAR
Studies have shown that the long-term wear of TN contact lenses for orthokeratology does not
eliminate the need to continue wearing contact lenses in order to maintain the orthokeratology
effect.  After the cornea has been flattened by wearing TN contact lenses for orthokeratology, the
patient will need to continue wearing Myopic Reduction Maintenance Lenses or Retainer lenses
for a portion of each day.  A Retainer lens may be either the last TN contact lens for
Page 64 of 72 orthokeratology design or a modification of this design in which the central portion of the lens
applies just enough pressure to the cornea to maintain the corneal flattening achieved but with no
additional corneal flattening.  The last pair of lenses in the fitting program is usually used as the
first Retainer Lens.  If it is found that this lens has a secondary curve that is too tight for the lens
to be worn on a long-term basis, a new Retainer Lens is prescribed which has the same base
curve but a flatter secondary curve, usually by one or two diopters.  The retainer lenses are
generally worn for the same daily schedule as the TN contact lenses for orthokeratology and
must be worn each day to maintain the orthokeratology effect.
One of the most common and effective schedules is to wear the retainer lens for several hours in
the morning and a few hours before bedtime.  Higher lens powers may require additional
wearing time.
It is important to make certain that the retainer lenses center well on the cornea, as the same lens
will be worn for a prolonged period.  Check the patient's lenses every 3 to 4 months.
RISK ANALYSIS
There is a small risk involved when any contact lens is worn.  It is not expected that the TN
contact lens for orthokeratology will provide a risk that is greater than other rigid gas permeable
contact lenses.
The two most common side effects that occur in rigid contact lens wearers are corneal edema and
corneal staining.  It is anticipated that the same side effects will also occur in some wearers of
TN contact lenses for orthokeratology.  Other side effects that sometimes occur in all contact
lens wearers are pain, redness, tearing, irritation, discharge, abrasion of the eye or distortion of
vision.  These are usually temporary conditions if the contact lenses are removed promptly.
In rare instances, there may occur permanent corneal scarring, decreased vision, infections of the
eye, corneal ulcer, iritis, or neovascularization.  The occurrence of these side effects should be
minimized or completely eliminated if proper patient control is exercised.  Patients should be
instructed to remove the contact lenses if any abnormal signs are present.  Patients should be
instructed never to wear their contact lenses while in the presence of noxious substances.
Patients should be instructed in the importance and necessity of returning for all follow-up visits
required by the eye care practitioner.
[Studies have not been conducted to support the safety and effectiveness of wearing TN contact
lenses for orthokeratology for overnight wear.]
FITTING OF TN CONTACT LENSES:
TN contact lenses for orthokeratology may be fitted using a modification of the standard
techniques for rigid gas permeable contact lenses.
Page 65 of 72 1.  Prefitting Examination:
A. complete refraction and visual health examination should be performed.
B. pre-fitting patient history and examination are necessary to:
  determine whether a patient is a suitable candidate for TN contact lenses for
orthokeratology.(consider patient hygiene and mental and physical state).
  collect and record baseline clinical information to which post-fitting examination
results can be compared.
2.  Initial Lens Power Selection:
Standard procedures for determining power of rigid gas permeable contact lenses may be
used, including compensation for vertex distance.
3.  Initial Lens Diameter Selection:
Usually, lens diameters between # mm to # mm are chosen to maximize centering to the
cornea and to minimize lens movement.  Lens diameters outside of this range are
occasionally used for some eyes.  This guide is only a general recommendation and the
specification for an individual patient will depend on the eye care practitioner's professional
judgment.
Determining Starting Lens Diameter:
If K is                                             # and flatter................use # mm diameter
                                                       # to #....................... use # mm diameter
                                                      # and steeper.............. use # mm diameter
Lens diameter is primarily a function of the base curve but may be influenced by power (plus
lenses require a larger diameter to compensate for weight) and anatomical considerations
(small palpebral opening, excessively large pupil, etc.)
4.  Initial Lens Base Curve Selection:
The base curve of the first lens fitted is generally fitted about # diopters flatter than the
flattest keratometric finding but may vary according to the following table, which takes into
account the corneal astigmatism.  This guide is only a general recommendation and the
specification for an individual patient will depend on the eye care practitioner's professional
judgment.
Corneal Astigmatism
0 to .75 flatter flatter flatter
1.00 to 1.50 flatter flatter flatter
> 1.50 flatter flatter flatter
Page 66 of 72 As shown in the above table, the base curve determination is a function of corneal cylinder
and lens diameter.  This guide is only a general recommendation and the specification for an
individual patient will depend on the eye care practitioner's professional judgment of the
lens movement and riding position as well as the fluorescein pattern analysis.
5.  Initial Lens Evaluation
Movement:
Blink induced lens movement should show downward lens movement with the lid
motion (average # mm.) and then upward with the lid motion (average # mm.) as with
a regular RGP contact lens.  During the interblink period the lens should have little or
no motion (average less than one millimeter).
Positioning:
The lens should position centrally or slightly superiorally to minimize both lens
movement and lid sensation.  The lens should not ride more than # mm. below center
nor # mm. above center.
Characteristics of a Tight (too steep) Lens:
A lens that is too tight will show reduced movement upon blinking.  The lens will be
centered or decentered inferiorly and exhibit little or no movement.  Bubbles may be
detected behind the lens.
Characteristics of a Loose (too flat) Lens:
A lens that is too loose will move excessively on the cornea following each blink.
The lens may ride in either a position that is too high or too low or in an eccentric
position.  A loose lens is usually uncomfortable for the patient.
TRIAL LENSES:
Trial Lens Fitting
Trial lens fitting is recommended whenever possible.  Trial lens fitting allows a more accurate
determination of lens specifications for the lens fit and power.  Choose the first lens according to
the table given for base curve selection.  Trial lenses are essential in fitting patients whose
corneal topography has been distorted by previous contact lens wear.
Trial Lens Set
A basic trial lens set consists of [describe lenses in this set].
CAUTION: Non-sterile lenses, clean and condition lenses prior to use.
Eye care practitioners should educate contact lens technicians concerning proper care of trial
lenses.  Each contact lens is shipped non-sterile in a case with no solution (dry).  Therefore in
Page 67 of 72 order to insure disinfection, clean and condition lenses prior to use.  Hands should be thoroughly
washed and rinsed and dried with a lint free towel prior to handling a lens.
Prior to reusing in a diagnostic procedure or before dispensing to a patient, lenses should be
surface cleaned and disinfected, following the manufacturer's instruction.
Trial Lens Procedure
Select a trial lens and place the lens upon the eye.  Evaluate the lens using white light for the
following:
1. Centering
Lens should center as well or better than a regular RGP lens.  The lens should be fitted
according to the interpalpebral fitting philosophy.  Lenses fitted according to the "lid
attachment" philosophy, in which the lens purposely rides in a high position should be
avoided.
2. Movement
Lens movement should be equivalent to or slightly less than a regular RGP lens, fitted-
according to the interpalpebral philosophy.
Evaluate the fluorescein pattern.  The fluorescein pattern should show a lens with definite
central touch, approximately # to # mm. diameter with a surrounding area of pooling.  In
the periphery there should be another area of touch and near the edge a thin band of
pooling [(Figure 2)].
The area of pooling near the transition between the base curve and secondary curve
serves as a reservoir for tears and as a potential space for corneal shifting during the
flattening process of orthokeratology.  The cornea molds by flattening the central cornea,
which reduces the space near the transition reservoir.  Hence, the size of the transition
reservoir, as observed from the fluorescein pattern, is a good indicator not only of the
initial fit of the lens but also of the progress of corneal flattening over time as the lens is
worn.
The fluorescein pattern provides the best method for monitoring the fit of the contact lens
over time.  As the cornea flattens, the area of pooling at the transition becomes less and
less.  When this occurs the lens begins to tighten and at some point barely moves on the
cornea.  The lack of pooling at the transition area indicates that the lens should be
changed for another that has a flatter base curve.
When the cornea has flattened enough for the desired reduction of the patient's myopia
(even though the fluorescein pattern indicates that further flattening is possible) it is time
to switch to a retainer lens.  A retainer lens is a contact lens that is designed to maintain
the current level of corneal flattening without additional flattening.  It is usually made
Page 68 of 72 with the same reverse geometry design as the last lens used for corneal flattening but with
less steepness for the secondary curve.
Limits of Flattening
In some cases the corneal flattening stops before a full reduction of the refractive error has been
accomplished.  Additional flattening may be possible by using a lens with a steeper secondary
curve (# or # diopters steeper than the base curve).  If no further corneal flattening occurs, it is an
indication that the patient should be fitted with a retainer lens.
FOLLOW UP CARE:
a.  Follow-up examinations, as recommended by the eye care practitioner, are necessary to
ensure continued successful contact lens wear.  Follow-up examinations should include
an evaluation of lens movement, centration, comfort and fluorescein pattern.  Lens
movement will decrease as tear volume is diminishing during adaptation.  The patient
should also begin to feel more comfortable.  An assessment of vision and eye health,
including inspection of the cornea for edema and/or staining should be performed.
b.  Prior  to  a  follow-up  examination,  the  contact  lenses  should  be  worn  for  at  least  4
continuous hours and the patient should be asked to identify any problems which occur that
are related to contact lens wear.
c.  With lenses in place on the eyes, evaluate fitting performance to assure that the criteria of
a well-fitted lens continue to be satisfied.  The fluorescein pattern provides a guide to lens
adaptation.  If the cornea flattens rapidly there will be a larger area of central touch and
the pooling at the lens transition will be reduced.  The lens will usually show reduced
movement.  These are indications that the lens can be exchanged for another of flatter
base curve.  Usually, a lens with a # diopters flatter base curve should be the next choice,
with variations from this up to the judgment of the eye care practitioner.
A lens with excessive movement should be replaced with another that is #mm larger in
diameter.
If the cornea shows no flattening the lens should be replaced with another that is #
diopters flatter with a secondary curve that is # diopters steeper.
d.  After  the  lens  removal,  conduct  a  thorough  biomicroscopy  examination  to  detect  the
following:
1.  The presence of vertical corneal striae in the posterior central cornea and/or corneal
neovascularization is indicative of excessive corneal edema.
2.  The  presence  of  corneal  staining  and/or  limbal-conjunctival  hyperemia  can  be
indicative of a reaction to solution preservatives, excessive lens wear, and/or a
poorly fitted lens.
Page 69 of 72 Solutions to various lens wearing problems are given in the following table
Ortho-K Problem Solving [In this section use the terminology appropriate for your lenses]
Fitting too flat may de-center the lens, cause vision problems and increase corneal astigmatism.
The most important points to remember are:
1.  CENTERING
2.  1-2 mm MOVEMENT
3.  MODERATE APICAL TOUCH
4.  PATIENT COMFORT
Problem Possible Cause Solution
tight lens or BC too steep flatten BC
no movement diameter to large reduce diameter
Loose lens BC too flat steepen BC
diameter too small increase diameter
High-riding BC too flat steepen BC
lens diameter too small increase diameter
high myopia use X
high amount of corneal astigmatism
Low-riding use  trial lenses to determine better
lens centration
Flare, Glare BC too flat steepen BC
or Ghosts poor centration increase size
too small use larger
Instability of quick, large corneal changes induces smaller BC changes
Ortho-k quicker & larger regression good centration at all times
changes rigidity of the cornea longer retainer wear
increase c6nter thickness
Fogging and dirty lens see "Lens Care'
scratchy lens improper care & handling of lenses
improper blinking
oily eye make-up removers
Page 70 of 72 increase in lens de-centered improve centration
corneal spherical lens being used? use OK design lenses
astigmatism starting corneal cyl ># D smaller BC changes
Poor VA with de-centered lens; displacement of improve centration
lenses corneal & visual axis check over-refraction
Poor VA w/out displacement of corneal & visual axis steepen BC increase diameter;
lenses irregular corneal astigmatism improve centration
RECOMMENDED INITIAL WEARING SCHEDULE:
Although many practitioners have developed their own initial wearing schedules, the following
sequence is recommended as a guideline.  Patients should be cautioned to limit the wearing
schedule recommended by the eye care practitioner regardless of how comfortable the lenses
feel.
The following schedule depends upon the professional judgment of the eye care practitioner and
should be modified according to the response to the initial lenses.
Daily Wear
Maximum wearing time
Day Wearing Time (Hours)
1 3
2 6
3 7
4 8
5 9
6 10
7 15
8 and after All hours awake10
Overnight Wear
Myopic Reduction Maintenance Lens (Retainer Lens)  Schedule
The retainer lens schedule must be customized for each patient.  The retainer lens wearing time
begins with the same wearing time required for the last fitted TN contact lenses for
orthokeratology.  There is considerable variability, however, as many patients require several
hours more or less than the averages.
Page 71 of 72 After a period of several days, or when the eye care practitioner is satisfied that the patient has
adapted to the first retainer lenses, the retainer lens wearing time can be reduced daily by
intervals of one hour.  This may continue for as long as the patient can see clearly for the
remainder of the day following lens removal.  When it is found that the patient experiences a
visual decrement following lens removal, the previous wearing time is then followed on a
constant basis.
HANDLING OF LENSES:
Standard procedures for rigid gas permeable lenses may be used.
Caution: TN contact lenses for orthokeratology are shipped to the
practitioner non-sterile.  Clean and condition lenses prior to use.
PATIENT LENS CARE DIRECTIONS:
Please see package insert and patient information booklet.
VERTEX DISTANCE AND KERATOMETRY CONVERSION CHARTS:
Standard charts may be used.
REPORTING OF ADVERSE REACTIONS:
All serious adverse experiences and adverse reactions observed in patients wearing
or experienced with the lenses should be reported to:
Applicants Name and Address
Telephone Number
HOW SUPPLIED:
Each lens is supplied non-sterile in an individual flat pack case containing one or two lenses.
The container is marked with the base curve, distance power, diameter, center thickness, [color]
and lot number.
Printed (Month/Year)
(package insert attached here)
End of Guidance
Page 72 of 72