Article Date: 1/1/2003

FDA LABELING
A Closer Look at FDA Contact Lens Labeling
Unearth buried information in all the fine print on the label and inside the box.
By James Saviola, OD, FAAO

Marketing clearance from the FDA is viewed as a "stamp of approval" that a product is safe and effective. The "intended use" of the manufacturer's product serves as the basis for setting the direction of the review process. Product labeling and any advertisements provided in the marketing application determine marketing performance claims and how the product is to be used.

As defined in Federal Regulations, intended use is the objective intent of the person legally responsible for labeling the product. Most contact lenses are intended to correct a person's refractive error or serve some therapeutic function. There are also prosthetic contact lenses intended for disfigured eyes as well as plano dioptric power lenses that alter the apparent color of the iris.

Information Under Wraps in Product Labeling

A product's labeling is more than just the information on the blister pack or lens vial. All contact lenses and care products reviewed by the FDA for marketing have numerous pieces of labeling. For contact lenses, the package insert, practitioner's fitting guide and patient information booklet along with the primary carton (blister pack) and secondary carton (box to hold blister packs) are submitted by manufacturers for review along with the preclinical and clinical information. Some companies combine the fitting guide with the package insert. For lens care products, the package insert, bottle label and outer packaging are reviewed.

Most practitioners could probably recite the fundamental information found within the package insert's various sections, which include actions, descriptions, indications, contraindications, warnings, precautions and directions for use. From training and licensing requirement, practitioners are familiar with fitting a contact lens and assessing the lens-to-corneal fitting relationship. While you may be knowledgeable about who to fit and when not to fit, the detailed information contained in the package insert serves as a handy reference for others working in the office.

The precautions sections of the package insert and patient booklet can help your staff consistently cover the do's and don'ts when instructing new patients. The patient booklet is an owner's manual for lens wearers. Providing written information for the novice lens wearer helps reinforce all the information covered in their training session.

It is the responsibility of a licensed practitioner who dispenses a prescription device to provide directions to his patients for use and cautionary statements. If you do not provide the manufacturer's patient booklet, and rely only on verbal instructions, many patients may forget what they have been told.

Myth vs. Reality: Are Expectations Too High?

Product labeling cleared by the FDA is a source of unbiased information free of marketing hype and salesperson spin. Contact lens labeling is written at different technical levels for doctors and patients. The package insert is primarily written for the practitioner. While much of the information concerning warnings, precautions and contraindications is consistent for many contact lenses, there are some notable exceptions.

The recently approved 30-day continuous wear lenses and orthokeratology lenses have a clinical study results section in the package insert that describes the pre-approval study. This provides information on the primary safety and efficacy outcome measures. A brief, less technical description of the study and outcomes is also included in the patient information booklet.

Taking a few minutes to review that clinical data in the labeling can help you develop reasonable expectations for your patients. This can save you time and headaches down the road by improving patient selection and communicating realistic expectations to your patients. Hidden pearls in the clinical data may influence your expectations.

30-day Continuous Wear Lenses

The mindset that a lens approved for 30 days of extended wear would work for just about everyone was one factor that led to trouble in the 1980s. Previously, the clinical outcomes from the FDA studies were not provided in product labeling. Initially, the risk information from epidemiological studies had not been published. Remember that continuous wear for 30 days won't be successful for everyone even with the approved new generation lens materials.

Let's look back at the approval data for one of today's commonly prescribed extended wear soft lenses. The FDA makes available a Summary of Safety and Effectiveness for selected Class III device approvals. The 1984 not-aphakic 30-day extended wear approval for the Vistakon Hydromarc (etafilcon A) lens, the grandfather of Acuvue, showed that 37 percent of the subjects were discontinued from the study. From the wearing time data collected, 59 percent of the completed subjects wore the lens for 21 days or longer. When you consider this wear time percentage in terms of the subjects initially fit in the study, it represents only 37 percent of those initially fit actually achieving wear longer than three weeks. Do you think that piece of data might have influenced expectations back in the mid 1980s? Let's look at the newer materials.

Discontinuation Rates and Wearing Time

CIBA's Focus Night & Day package insert reports that 697 subjects were fit with Night & Day for 30-day wear and 698 with a control lens for seven-day extended wear. Some 483 Night & Day subjects and 579 controls completed one year of wear. That's about a 31 percent discontinuation rate for Night & Day compared to 17 percent for the control lens. For those subjects completing the study, 67 percent wore Night & Day for 22 to 30 days. This corresponds to less than 50 percent of those initially enrolled wearing the lens longer than three weeks.

The Bausch & Lomb PureVision study was different because subjects were fit in a contralateral manner with one eye wearing PureVision for 30 days and the other eye wearing a seven-day control lens. The data show 610 of the 820 enrolled subjects completed one year, a 26 percent discontinuation rate. Of the 210 discontinued subjects, 28 either didn't adapt to daily wear or were not dispensed lenses. Even with strict selection criteria for enrollment into the study, 13 percent of the discontinued patients didn't make it to overnight wear. The B&L data reports that 94 percent of the times that they were asked, subjects were able to wear PureVision at least 22 days. A reasonable clinical impression is that about two-thirds of the subjects achieved a wearing time of at least three weeks with the PureVision eye.

These results may not be a good representation of your clinical practice. B&L was more active in discontinuing subjects who did not maintain the full wearing schedule for the test lens. When you consider how patients were managed for wear time along with the difference in study design, it is difficult to compare the wear time data with CIBA.

For the Menicon Z gas permeable lens 30-day study, 59 of the 317 test subjects (19 percent), and 103 of the 313 control subjects (33 percent), discontinued. Average wearing times of 22 days or more were reported at 67 percent of all visits for the Menicon lens after the first month. This represents 54 percent of all GP patients initially fit.

From the data, one may form the clinical impression that about one-half to two­thirds of those attempting lens wear for longer than three weeks are successful. Bear in mind that these also represent people selected with very strict enrollment criteria that may already have been successful in extended wear. If you don't read the clinical data section in the labeling, you won't know the success rates.

Infiltrate Rates

Because microbial keratitis is a rare event, occurring at about 1:500 extended wear patients, corneal infiltrates were used as the safety outcome in the pre-approval studies.

The same commonly prescribed seven-day extended wear lens was used as the control lens for the Menicon lens study and the two silicone hydrogel lens 30-day studies. The clinical impression from these data is that silicone hydrogel lenses worn for longer wear periods have a higher infiltrate rate, but the rate is an order of magnitude lower with the GP lens in continuous wear.

In the B&L labeling, there are other important infiltrate rate data concerning different lens powers. The CIBA labeling has good information about clinical outcomes during the first month of wear. The oxygen transmissibility values vary for the three lens materials across the dioptric power range. As a result, the lens powers that meet the Holden-Mertz criteria are different for the three approved 30-day lenses. This is discussed in "Special Precautions for Eyecare Practitioners" found in the "Precautions" section of the package insert.

Alternate Designs

The general intended use of most contact lenses is to correct refractive ametropia. However, some contact lenses have a specific intended use targeted for a type of ametropia or patient population. The basic correction or ametropia­myopia, hyperopia and astigmatismis applied across all age ranges. Correction for more specific patient populations involves specialized uses such as aphakia, presbyopia, keratoconus, orthokeratology or post-refractive surgery. FDA marketing clearances are necessary for these alternate designs. The FDA regulates the final finished contact lens as the device, so GP lens buttons or blanks are not considered finished medical devices.

Once an original material is cleared for marketing, the true success of a new lens design usually comes down to an issue of efficacy. Since 1988, FDA guidance to manufacturers has not recommended that presbyopic lens designs be clinically evaluated. Instead, emphasis is placed on the optical design theory of the lens and the product labeling. This was a big departure from the first toric and presbyopic lens reviews that involved hundreds of patients followed for six to 12 months in a clinical study.

The "Special Precaution for Eye Care Practitioners" in the package insert emphasizes that the final outcome of the lens fitting, and success for a specific patient, is up to the practitioner. Ultimately, that is where the decision belongs. Multifocal lens success is correlated with careful patient selection, practitioner knowledge and skill regarding the nuances of the lens design used and patient acceptance of their vision. Success is achieved with some, but not all patients.

Orthokeratology

Orthokeratology lenses are an example of an alternate lens design for a specialized use that required clinical data to evaluate the safety and efficacy. The ability to communicate reasonable expectations about lens efficacy was a primary concern when the first daily wear ortho-k lens was cleared for marketing in 1998. A two-part patient booklet was developed for users in addition to providing the clinical data in the package insert and practitioner labeling. The first part of the patient booklet, which communicates outcomes from the FDA study, is intended for prospective patients. The second part contains the basic lens instructions and lens care information after the lens is fit and dispensed. This labeling model has been used for all three manufacturers with daily wear ortho-k clearances, as well as for Paragon CRT overnight approval.

Overnight wear of ortho-k lenses creates an additional safety concern due to the closed-eye setting. These lenses are regulated as Class III medical devices due to the increased risk relative to daily wear. Because traditional methods of fitting GP lenses are not used with reverse geometry designs, the FDA restricted use of these lenses only to practitioners who were trained in the use of the device. This provision had never been used for contact lenses, although it has been used for other ophthalmic devices such as excimer lasers for refractive surgery.

The clinical data for both daily wear and overnight wear show a greater efficacy in terms of percent corrected to 20/20 for subjects treated with lower amounts of myopia. The daily wear data showed a fairly high percentage of subjects wearing lenses more than four hours per day. The overnight data from the Paragon study showed that the lasting effect of treatment is correlated with the pretreatment refraction and the refraction at lens removal. Patients who are slightly hyperopic upon lens removal enjoy a longer treatment effect. This regression data is valuable information for both practitioners and patients.

What "Disposable" Means

The regulatory definition of disposable is "single use." In the marketplace, the term is used for lenses replaced within two weeks or less. When disposable lenses were first approved, the fitting guide discussed the option to fit lenses as disposable­single use, or on a planned/frequent replacement schedule. The patient instruction did not provide both options in a single booklet. Two separate booklets were required: the replacement schedule booklet with lens care directions and the disposable schedule booklet with the single-use direction. This approach was taken to better foster one-time single use for those patients prescribed that lens wear pattern.

The two silicone hydrogel lenses recently approved for 30 days of wear have a single patient booklet combining both wearing schedules. This departure from the previous model results in consistent directions in both the practitioner and patient labeling. It is also less burdensome on manufacturers to have a single patient booklet. All terminology aside, the critical information that a patient needs to know is that the lens should either be thrown away when removed from the eye, or properly cared for with a lens cleaning and disinfecting product.

Problems Acquiring Contact Lens Labeling

Contact lens manufacturers have a regulatory obligation to provide package inserts, patient information booklets and practitioner fitting guides upon request. However, getting your hands on contact lens labeling is not always easy. For lens care products, it's easy to find the package insert because it's either packaged with the bottle, or printed on the inside of the outer carton.

When you order directly from the contact lens manufacturer, you have a very good chance of having one package insert included in each shipment, no matter how many orders for different patients are in one shipment or how many times you have ordered before. If you order from a distributor, your chance of getting a package insert decreases. Orders placed with a buying group may either be filled directly from the manufacturer or a distributor.

Your ability to easily obtain copies of various labeling pieces will vary by company. Some manufacturers have links on their website to package inserts and patient instruction guides. A call to your sales representative may result in delivery to your office, or you may get referred back to the company. Sometimes you don't receive what you wanted. It's not uncommon to be sent tri-fold marketing pamphlets for displays in your waiting area instead of patient information booklets. Persistence may be needed to improve your chance of success.

Labeling Examples and Their Real Meanings

Selected out-takes from contact lens labeling that are standard for most contact lens package inserts.

Precautions

Special Precautions for Eyecare Practitioners:

Key Meaning

Wearing Schedule

The wearing and replacement schedules should be determined by the eyecare practitioner.

Key Meaning

Presbyopic and Monovision Fitting Guidelines:

a. Monovision Needs Assessment

For a good prognosis, the patient should have adequately corrected distance and near visual acuity in each eye. Monovision contact lens wear may not be optimal for such activities as:

(1) visually demanding situations such as operating potentially dangerous machinery or performing other potentially hazardous activities; and

(2) driving automobiles (driving at night). Patients who cannot pass their state driver's license requirements with monovision correction should be advised to not drive with this correction, OR may require that additional over-correction be prescribed.

b. Patient Education

All patients do not function equally well with monovision correction. Patients may not perform as well for certain tasks with this correction as they have with bifocal reading glasses. Each patient should understand that monovision, as well as other presbyopic contact lenses, or other alternative, can create a vision compromise that may reduce visual acuity and depth perception for distance and near tasks. During the fitting process, it is necessary for the patient to realize the disadvantages as well as the advantages of clear near vision in straight ahead and upward gaze that monovision contact lenses provide.

Key Meaning:

Conclusion

If you have never read any of the labeling mentioned, you owe it to yourself and your patients to invest a little time. Perhaps you will realize there is something worthwhile buried in the fine print of the product labeling. Although a device may be intended for a specific use, its actual effects have important clinical and public health implications. As we embark upon this new excursion into continuous wear, keep in mind that without adequate risk information, you and your patient cannot make a mutual informed decision on treatment. Product labeling is an essential piece for communicating this information.

Dr. Saviola is a branch chief in the Division of Ophthalmic and ENT Devices of the FDA's Center for Devices and Radiological Health. He is a Captain in the U.S. Public Health Service and is an optometry consultant at the National Naval Medical Center, Bethesda, MD.

This paper represents the professional opinion of the author and is not an official document, guidance or policy of the U.S. Government, the Department of Health and Human Services, or the Food and Drug Administration, nor should any official endorsement be inferred.

 

 

What you already know Where it's available
How to fit a contact lens Practitioner Fitting Guide
How to instruct patients  Patient Information Booklet and Package Insert (written for the practitioner)
What's on the label Package insert and Primary label and secondary carton

 

 

 

 

Focus Night & Day (lotrafilcon A) Soft Contact Lenses
www.fda.gov/cdrh/pdf/p010019.html

PureVision (balafilcon A) Visibility Tinted Contact Lens
www.fda.gov/cdrh/pdf/p980006s004.html

Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lens
www.fda.gov/cdrh/pdf/p990018s002.html

Paragon CRT (paflufocon B), Paragon CRT 100 (paflufocon D), Paragon Quadra RG (paflufocon B), and Paragon Quadra RG™ 100 (paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy
www.fda.gov/cdrh/pdf/P870024S043.html

The following website may be used to search for Information on other Class III PMA approvals:
www.fda.gov/cdrh/pmapage.html

Use this website to search the Releasable 510(k) database for Class II clearances:
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

 


Contact Lens Spectrum, Issue: January 2003