Article Date: 1/1/2002

Contact Lenses 2001

By Joseph T. Barr, OD, MS, FAAO
January 2002

From extended wear and no rub to lawsuits and ortho-k, look back at the controversy, innovation and optimism of 2001.

Although overall contact lens sales were generally flat in 2001, there were many noteworthy changes in the field. The long-awaited FDA approval of CIBA Vision's Focus Night & Day and Bausch & Lomb's PureVision lenses for 30 days of continuous wear was remarkable. Consumer advertising and public relations efforts by the companies, as well as education of practitioners, will bring many patients to this modality. Even countermeasures by companies who do not have 30-day approval are likely to heighten awareness of this option. In fact, by the end of 2002, it is likely that 30-day continuous wear of hyper-Dk RGP lenses in the form of Menicon's Z material will have FDA approval.

Silicone hydrogel lenses may indeed cause fewer infectious keratitis in long-term lens wear. CIBA Vision claims that over 250,000 people, half of whom are female, have worn Focus Night & Day. The typical contact lens population is two-thirds female. A new web site, www.siliconehydrogels.org, provides general information about these lenses. CIBA Vision reports that, according to one survey of 500 ODs, 46 percent will try the lenses on selected patients, 12 percent will aggressively refit current disposable lens wearers, 27 percent would recommend the lenses to patients who asked, and 15 percent wanted to wait until more data was available. In the UK, Philip Morgan, PhD, indicates that in the past year continuous wear fits grew, accounting for 12 percent (96 percent silicone hydrogels) of fits, up from less than four percent the previous year. 

At least 40 percent and perhaps two-thirds of patients desire this modality if their eyecare practitioners would recommend it. In fact, even though daily disposable lens use is the healthiest way to wear contact lenses, patients prefer the convenience of extended wear, according to a study published by Jason Nichols, OD. Like refractive surgery, most patients are very happy with a continuous wear modality. Nevertheless, a low percentage of patients will experience inflammatory side effects that will need to be managed, such as GPC, superior corneal epithelial arcuate lesions (SEALs) and mild infiltrative keratitis. Most practitioners are more prepared than ever to manage these side effects. The FDA is requiring that the manufacturers of silicone hydrogel lenses perform post-marketing surveillance to monitor long-term safety of these devices.

High Dk, overnight lens corneal refractive change, commonly known as overnight orthokeratology, is likely to have a number of approvals in 2002. The Global Orthokeratology Symposium will be held in Toronto, August 9-11, 2002. See Contact Lens Spectrum's web site at www.clspectrum.com. Both Paragon with its Corneal Refractive Therapy (CRT) design and Polymer Technology Corp./B&L with multiple designs are likely to attempt to capture a share of this undeveloped and controversial practice for myopia management.

While optometrists who fit most of the contact lenses in the United States worry about mostly non-sight-threatening continuous wear complications, ophthalmologists and many optometrists merely go about recommending LASIK. Estimates range from 30,000 to 50,000 patients who will have unsatisfactory outcomes with LASIK in 2001. Indeed, more of these people will have loss of vision and decreased quality of life than with continuous wear contact lenses. I'm not saying two wrongs make a right, but for convenient vision correction, continuous wear seems safer than LASIK. It is ironic that many of the refractive surgery disasters require a contact lens for best corrected vision.

Wearer Trends ­ More Teens and Presbyopes   

Early in 2001, office visits for lenses were up, but as the year went by and the economy weakened, the industry did as well. We now estimate there are just over 32 million contact lens wearers. Depending on the source, somewhere between 80 and 89 percent of contact lens patients wear soft contact lenses, and thus between 11 and 20 percent wear RGP lenses. Nearly three-fourths of these patients wear single vision lenses. Table 1 estimates how we believe current lens wearers are categorized in the United States.

 

TABLE 1United States Contact Lens Wearer Breakdown by Percent (estimate)

Rigid Contact Lenses  15
Soft Contact Lenses 85
Disposable Spherical 50*
Planned Replacement  15
Toric  10
Colors 8
Bifocal 2
* includes daily disposable

 

There may have been over a 10 percent increase in the use of daily disposable lenses in 2001, but much more growth is expected as people begin to learn how economical and healthy disposable lenses can be. Much of the marketing for these lenses has been directed at teens, the majority of new contact lens wearers.

Figure 1. Lens wearer trends from 1990-2000.

CIBA introduced Focus Dailies Progressives, and Focus Dailies received an FDA claim for reducing the symptoms of seasonal allergic conjunctivitis. Vistakon relaunched a monocurve back surface 1­Day Acuvue with improved handling and launched Acuvue 2 Colours opaque and enhancer lenses. B&L increased promotion of SofLens One Day, and Ocular Sciences announced plans for a one-day disposable lens. The increased use of disposable lenses is at the expense of conventional lenses (Figure 1).

Although the number of bifocal and multifocal lens patients remains low, there was a nearly 20 percent increase in the bifocal lens category in early 2001, and disposable and planned replacement toric lens new fits increased nearly 15 percent in the first half of 2001. Some 75 percent of U.S. eyecare professionals report an increasing patient demand for soft bifocal and multifocal lenses, according to an e-mail survey of more than 500 practitioners by CIBA. The survey indicated that 64 percent of these practitioners have a fitting success rate of 50 percent or greater with these lenses.

One driver of lens sales has been manufacturer rebates. Some 35 percent of practitioners indicate a third of their patients used rebates this past year. Increased lens sales have been occurring via the Internet, causing many practitioners to offer this service from their practice web sites.

Keep in mind that although 50 percent of lens wearers have lenses prescribed on a two-week or less replacement schedule, they dispose of the lenses half as often. Some 70 percent of these patients wear their lenses seven days per week, although daily disposable and opaque colored lens wearers are likely to wear their lenses less than seven days per week. This heightens the need for proper lens care.

 

2001: A Big Year For Optimism

 

Wavefront technology will someday enable the fabrication of contact lenses that can provide better than natural vision. The long-awaited FDA approval of 30-day contact lenses was followed by CIBA's consumer research indicating that 35 percent of wearers don't want to remove lenses every day. This offers a genuine alternative to refractive surgery and confirms my assumption that the "hassle factor" is the greatest single deterrent to contact lens wear.

­Bob Koetting, OD, FAAO

While I believe LASIK has its place, the bad press, deserved or undeserved, boosted contact lenses. Couple this with doctors finally starting to understand the patient drivers for daily disposables and the approval of 30-day continuous wear/single use lenses, I see a significant resurgence on the horizon for contact lenses. Given the undeniable fact that no patient really cares properly for his lenses, or complies with regular replacement of his lenses, I'm advising my consulting clients to aggressively promote the combination of one-day and 30-day lenses.

­Gary Gerber, OD

Final FDA approval of the first 30-day silicone hydrogel continuous wear lens is just the beginning of this mode of wear and only the first generation of these breakthrough polymers.

­Loretta Sczcotka, OD, MS, FAAO

The continued refinement of refractive surgery will have an increasing impact. Mergers, and thus fewer players, dropout of some products, increased costs of certain vialed products and less funding available for continuing education activities all have an influence.

­Michael A. Ward, MMSc, FAAO

1-800 Contacts' Day(s) in Court

In 2001, 1-800 Contacts reported that it believes Vistakon is required to sell contact lenses to the company as a result of Vistakon's class action suit settlement but that Vistakon had refused to open an account with 1-800. The alternate distributor now purchases contact lenses directly from CIBA Vision and Bausch & Lomb, as per prior settlements. 1-800 Contacts also reported internal data that indicates its average two-week disposable lens customer buys 40 lenses per year, which is higher than a report published in April 2001 Contact Lens Spectrum quoting recent CIBA market research as saying the average two-week disposable lens patient buys 28 lenses per year. 1-800 says it provides not only a financial benefit to consumers but a health advantage as well, claiming that when lenses are less costly and more convenient to replace, compliance increases.

In late 2001, Johnson & Johnson filed suit against 1-800 Contacts and went to court to ask a judge to force the Internet company to stop allegedly misleading advertising. J&J claimed 1-800 was promoting Vistakon lenses to lure customers to the site only to sell them lenses from J&J's rivals. J&J never sold its lenses directly to 1-800 Contacts, and until recently, 1-800 has sold J&J lenses it obtained through "unauthorized channels." J&J claimed 1-800 lost its "back-channel sources," which included products intended for overseas markets, this past summer.

1-800 said in July that Vistakon's refusal to supply it with lenses hurt its third-quarter sales and is inconsistent with the antitrust settlement. The J&J complaint, filed in U.S. District Court in Jacksonville, Fla., in October, sought a preliminary injunction and financial damages. In late November, federal judge John Schlesinger (Florida) said 1-800 was using deceptive advertising with regard to Vistakon's lenses and ordered the company to discontinue the practice. He told 1-800 it could not use a study comparing the modalities of two lenses as if it were comparing the quality of the lenses.

The J&J suit also claims that from September through November, contact lens practitioners received recorded messages, often during times when their offices were closed, from 1-800 Contacts requesting patients' contact lens prescriptions and threatening to list the practitioners as not compliant if they did not produce the prescription. The suit also claims that 1-800 prompted patients to see a different practitioner to obtain a prescription for a lens other than an Acuvue lens, and then paid that practitioner for switching the consumer to the other brand, typically CIBA Vision lenses. CIBA Vision said it was not cooperating with this approach.

Early in 2001, a hearing was postponed by a Texas legislator regarding two pending bills because he was "disgusted" with some of the tactics of 1-800 Contacts, who had offered to fly consumers to the hearing, pay for gas and parking for local consumers to attend and provide lunch with the company's chief executive officer. The two bills would have required eyecare practitioners to give contact lens prescriptions to consumers, even if the prescriptions were not requested, and enable contact lens distributors to fill orders without having a signed prescription or a callback from a practitioner's office. 1-800 Contacts claims to have 70 percent of the mail/computer order contact lens replacement business.

Lawsuits Finally Settled

Vistakon settled two lawsuits in 2001. In New Jersey, attorneys for the plaintiffs claimed 1-Day Acuvue lenses were no different from Acuvue lenses. Although Vistakon established they were not the same lens, the company did change some aspects of 1-Day Acuvue labeling. Under the settlement, Vistakon agreed to remove the words "disposable" and "for single use" from its 1-Day Acuvue pack-aging and provided a combined cash and coupon total of about $140 per consumer in the class.

In the more significant settlement with the attorneys general of 32 states, Vistakon agreed to sell to alternative lens providers if the companies followed state laws for contact lens prescription filling. Previously, CIBA Vision, Bausch & Lomb, some individuals and the American Optometric Association had settled this 1994 class action suit. The suit's plaintiffs claimed the companies and individuals had conspired to fix prices and prevent other channels of trade and violated antitrust laws, jumping prices above competitive levels. These settlements caused some practitioners to be overwhelmed with patient inquiries. Some purchasers of the companies' lenses since January 1, 1988, could receive $50 to $75 lens discounts, $25 off eye exams and, in some instances, cash.

Contact Lenses on the Internet

Ocular Sciences succeeded in stopping sales of its lenses from unauthorized wholesale distributors such as JG Optical in New York and Weblens.net, a Canadian-based contact lens Internet retailer which OSI claimed violated company policy, changed labels and sent its customers an e-mail saying another company's lens, to which the Internet company had access, was "virtually" the same as the Ocular Sciences lens. OSI also announced it had resolved its legal dispute with Go2Contacts.com, an Internet seller of contact lenses. The Internet company agreed not to purchase, distribute, advertise or sell any Ocular Sciences lenses, not to substitute other companies' lenses when a customer wants to order an OSI product and to remove all references about OSI from the Go2Contacts.com web site.

CooperVision introduced the Ascend Monthly aspheric soft lens direct to the patient as instructed by the doctor over the Internet from coopervision.com.

Biocompatibles tried hard to keep its lenses from nonclinician sellers but admitted in 2001 that some Proclear lenses came from Europe to the United States.

Contact Lens Prescription Law

Rep. Pete Stark (D-Fremont) reintroduced federal legislation that, if passed, would legally entitle consumers to their lens prescriptions. Previously, Stark unsuccessfully attempted to pass similar legislation, but this time has support from the House Judiciary Committee chair, the discount lens industry and the Consumers Union, publisher of Consumer Reports.

The FDA has posted a list of consumer guidelines for purchasing lenses over the Internet, cautioning consumers to have a valid prescription when ordering, advising them to get regular check-ups before buying lenses online and warning them about Internet vendors who substitute brands. The site also provides an opportunity for consumers to report problems with Internet vendors. To learn more, visit www.fda.gov/cdrh/consumer/buycontactqa.html

No-Rub Solutions Make Waves in 2001

Consumer market research indicates that only 50 percent of contact lens wearers rub their lenses all or most of the time during their lens care procedures. This year, Alcon aggressively promoted Opti-Free Express as a no-rub system. Allergan's Complete, which claims long-term comfort due to the action of hydroxymethylcellulose, CIBA Vision's new (hydrogen peroxide) ClearCare and B&L's ReNu are all now no-rub approved. B&L may release a new multi-purpose solution soon. As mentioned earlier, 50 percent of patients who have lenses prescribed on a one- or two-week replacement schedule replace the lenses, on the average, at one-month intervals. Most no-rub solutions are approved for lenses used for up to 30 days. Only Opti-Free Express is approved for lenses used up to six months.

Alcon's Unique pH for RGP lenses, which features greater viscosity off the eye and lower viscosity on the eye, was introduced and is being used with a number of wet-shipped RGP lenses.

Nestlé may sell 25 percent of Alcon next year to help the company improve its market position. Alcon could be worth more than $12 billion.

More, and Better, Lenses

CooperVision introduced Frequency 55 Disposable Toric and Frequency 55 Multifocal (center near one eye and center distance opposite). It also introduced its Expressions disposable opaque colored lenses.

OSI's Biomedics Toric is a new, disposable, patented ballast design with a uniform horizontal thickness and a "constant ramp angle." Ocular Sciences bought Essilor's soft contact lens businesses, including Sunsoft, in 2001. Ocular Sciences announced plans to launch colored contact lenses and a single-use disposable lens, as well as open a new plant for its daily disposables in 2002. OSI and Asahikasei Aime Co. plan to produce a lens using OSI's cast molding manufacturing method and Asahikasei's new silicon-based material. No set timetable has been established for this lens, which is expected to be hydrophilic, offer high oxygen permeability and have extended wear characteristics.

UltraVision Corp granted an exclusive contract to CIBA Vision for the distribution of its Specialty Choice AB lens.

Scioptic introduced Tritan, a new translating soft bifocal lens from Gelflex (Perth, Australia).

Bausch & Lomb has licensed the exclusive worldwide rights to a patented multifocal soft contact lens design from Unilens Corp. B&L will develop, manufacture and market the cast-molded lens for frequent replacement using the Unilens technology.

In the RGP arena, the CLMA is using the term "gas permeable" instead of "rigid gas permeable."

ConCise Contact Lens, Inc of San Leandro, CA, has become the U.S. distributor and manufacturer of Menicon lenses.

Paragon promoted its corneal refractive therapy design, CRT, in the United States for daily wear and in Canada for overnight wear. The company is also promoting its new RGP HDS 100.

Polymer Technology/Bausch & Lomb promoted its Boston XO with a Dk of 100.

In 2002, Joe Benjamin will publish new Dk values for RGP materials in Optometry and Vision Science.

Looking Ahead

Many believe that "implantable contact lenses" will have long-term complications, and others believe they will be a major competitor to contact lenses. Health Canada issued a Medical Device License for STAAR Surgical's Implantable Contact Lens (ICL) for myopia and hyperopia. According to the company, it is implanted in front of the human lens in minutes, adding that the ICL makes no permanent change in the structures of the eye, and the procedure is reversible.

In this new millennium, there will be many opportunities for practitioners to offer alternatives for nearly every type of refractive correction and provide our patients with more options with more success than ever before.

We mourn the loss of our wonderful contact lens friends and developers in 2001, especially Tom Brungardt and Steven Downs.

Dr. Barr is editor of Contact Lens Spectrum and assistant dean of Clinical Affairs at The Ohio State University College of Optometry.

 

TABLE 2: Contact Lens Spectrum Reader Survey Results

Question Percent
Over 10 contact lens fits/refits per week 58
Ninety percent or more of fits/refits are soft lenses 47
Fifty percent of fits/refits are RGP  14
Over 30 percent of patients in practice wear contact lenses 53
At least 30 percent of gross revenue from contact lenses 45
At least 20 percent of net profit derived from contact lenses 63
Recommend a specific brand of lens care to each patients 82
Practice uses lens replacement mail program 70
Release contact lens Rx:  

To every patient

14

Only when I have to

25

Whenever asked

 58
Write more than 10 TPA prescriptions per week 24
In the next year, do you see the following increasing?  

Overall contact lens practice

66
Disposable contact lens business 61
Daily disposable contact lens business 45
Extended wear 25
Soft toric 55
Bifocal/multifocal 57
RGP 14
N= 97 to 324 responses

          

 

There is no such thing as justice ­ in or out of court -Clarence Darrow, 1936
By Paul Klein OD, FAAO

 

If you are an OD and you don't know that that you've lived through the biggest lawsuit ever brought against ODs and contact lens manufacturers, you must have been asleep for the last decade. I have not been asleep. As a named defendant, this case has been a 10-year sobering lesson in how rapidly ODs adapt to change and how slowly the legal system grinds to a determination of "truth."

The attorneys general of 32 states charged Bausch & Lomb, CIBA Vision, Vistakon, the AOA and various individual ODs with engaging in a restraint of trade conspiracy from about 1987 to 1993 with two objectives: to pressure contact lens manufacturers to stop selling lenses to alternative channels of distribution and to encourage the withholding of lens prescriptions so consumers could not comparison shop for replacement lenses. The suit claimed that the conspiracy artificially raised the retail price of replacement lenses.

The process spanned 10 years and consumed millions of dollars in attorney's fees alone. When the cobwebs cleared, CIBA and B&L settled before trial, and the AOA, Vistakon and individual defendants agreed on a settlement two weeks into trial. The fact that there was a settlement at trial is revealing. Defendants who settle prior to trial generally do so because they believe the cost of a potential loss may far outweigh that of a settlement. Plaintiffs who settle at trial generally do so because of they fear the jury may come in with an adverse verdict.

In this case, the plaintiff states accepted a monetary settlement to "avoid continued litigation." The Court acknowledged that the settlement was not admission of guilt by the defendants. The defendants for their part agreed not to do what was never proven they did.

No one reading this who fit contact lenses between 1987 and 1993 can fail to see the sublime anachronism represented by this litigation. During the time the conspiracy is alleged to have occurred, those alternative channels increased their market share from zero to over eight percent. During the same time the average retail price of disposable six-packs fell from $25 to a low of $14.95. All the while, patients were getting their lens prescriptions. How else could one explain the tremendous growth in the number of mail-order houses?

The fundamental irony inherent in this litigation is that while the plaintiff states were constructing a case based on decades-old circumstantial evidence, the market and the ODs were already self-correcting.

ODs responded to the unexpected change represented by disposable lenses the way human beings always respond to such change: apprehension, resistance, re-evaluation, adaptation and absorption. In 1986, no one could have predicted whether mail-order houses would follow state dispensing statutes. The evidence then, and since, indicates otherwise. Mail order was a new phenomenon with a history replete with fraud. No one could have known in 1987 how reproducible disposable lenses would be; how patients would embrace them; how much of a commodity product they would become; or how acceptable mail order and e-tailing would become. As an accused conspirator, an OD long involved in contact lens clinical trials, a contact lens industry consultant, a former editor of a national optometric publication and an astute businessman, I can state with absolute certainty that had this case not been brought in 1991, the contact lens market would be no different today.

How much impact will this case have on ODs? On the OD defendants, none. On ODs at-large, very little. ODs have long been releasing contact lens prescriptions. No OD I know has ever seriously believed that he could individually or collectively stop the advance of alternative channels of distribution.

Some consumers will enjoy a windfall from the rebates that were part of the settlement. Most consumers will ignore the rebates because they never believed they were overcharged for replacement lenses. In fact, nowhere in the thousands of pages of testimony have I ever seen the testimony of a single consumer who accused an OD of overcharging for replacement lenses.

Other 2001 News and Help

 


Contact Lens Spectrum, Issue: January 2002