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Guidance for Industry: Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses

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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 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

Guidance1 for Premarket Submissions of
Orthokeratology Rigid Gas Permeable
Contact Lenses

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.

___________________
1This document is intended to provide guidance. It represents the Agency’s 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.

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.

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.

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.

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.
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.
  • 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.
 
  1. Refractive Power:

    An analysis of reduction of refractive error by pre-treatment manifest refraction should be provided. This should include:
   
  • 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.
 
  1. 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 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.
 
  1. 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.
 
  1. 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 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.
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
2.00 D

2.25 to
3.00 D

3.25 to
4.00 D

4.25 to 5.0 D

5.25 to
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.

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
2.00 D

2.25 to
3.00 D

3.25 to
4.00 D

Etc.

Totals
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.                        
                         

DEMOGRAPHICS OF REFRACTIVE PARAMETERS

Corneal Astigmatism

Pretreatment Myopia (Spherical Diopters)

1.0 D

1.25 to
2.00 D

2.25 to
3.00 D

3.25 to
4.00 D

Etc.

Totals
 

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

Refractive Change from Baseline Visit
Pretreatment Myopia (Spherical Diopters)

1.0 D

1.25 to
2.00 D

2.25 to
3.00 D

3.25 to
4.00 D

Etc.

Totals
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.            

ACCURACY OF INTENDED VS. ACHIEVED CORRECTION*
STRATIFIED BY DIOPTRIC GROUP
AT EACH 3 MONTH VISIT

MR

Pretreatment Myopia (Diopters)

1.0 D

1.25 to
2.00 D

2.25 to
3.00 D

Etc.

Totals
 

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          

STABILITY OF MANIFEST REFRACTION*
STRATIFIED BY DIOPTRIC GROUP

Change in Spherical Diopters

Pre-treat and
1 Month n/N (%)

1 and 3 Months
n/N (%)
 

Pre-treatment myopia
 

1.0 D

1.25 to 2.00 D

2.25 to 3.00 D

ETC.

1.0 D

1.25 to 2.00 D

2.25 to 3.00 D

ETC.
  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.

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 in Flat meridian

1.0 D

1.25 to
2.00 D

2.25 to
3.00 D

3.25 to
4.00 D

Etc.

Totals
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

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
2.00 D

2.25 to
3.00 D

3.25 to
4.00 D

Etc.

Totals
 

n/%

n/%

n/%

n/%

  

n/%
20/20 or better            
20/25 or better            
20/32 or better            
20/40 or bette            
20/80 or better            
20/200 or better            
Not reported            
Total            

SUMMARY OF INTRAOCULAR PRESSURE

IOP Initial Visit
n/N (%)		 3 Month
n/N (%)		 Final
N/N (%)
       
       
       
       
       
       
       

* Indicate method of measurement

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
2.00 D

2.25 to
3.00 D

3.25 to
4.00 D

Etc.

Totals
 

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 ³2 LINES OF BSCVA

 

Pre-treatment

3 Month

Patient code

 UCVA MR BSCVA UCVA MR BSCVA
             
             

SUMMARY OF KEY SAFETY AND EFFICACY VARIABLES

 

1 Month
n/N (%)

3 Month
n/N (%)

each 3 Months
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 12.0

Etc.

Total
 

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              

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.

Applicant’s Name
Address


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

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.

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.

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 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.

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.

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
Myopia

REDUCTION
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.

PERCENT OF EYES THAT ACHIEVED FULL OR PARTIAL
TEMPORARY REDUCTION OF MYOPIA

INITIAL
MYOPIA

FULL
TEMPORARY
REDUCTION

UP TO 0.50 D.
UNDER FULL
REDUCTION

FINAL V.A.
20/20 or better

FINAL V.A.
20/40 or better

<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:

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 days

%

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:

Applicant’s 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.

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].

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.

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)

Applicant’s Name and address

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