Article Date: 6/1/2006

SPECIAL ANNIVERSARY SECTION - CLS 20TH ANNIVERSARY
20 Years of Contact Lenses
We look at how far the contact lens industry has come over the last two decades and where it may be heading.
By Joseph T. Barr, OD, MS, FAAO, and CLS staff

Many people use the word breakthrough freely. It was Bob Mandell, OD, PhD, who reminded us that fewer major turning points have occurred in contact lenses than many would claim. Certainly, the introduction of Professor Otto Wichterle's soft contact lens in the early 1970s was a breakthrough. The development of modern GP lens materials probably qualifies as well.

To celebrate the 20th anniversary of Contact Lens Spectrum, we intend to discuss major milestones that have occurred in the contact lens field over the past 20 years. We outline and discuss what we believe are the top 20 events that happened in the contact lens field during that time. Only time will tell if any of these events and developments were true breakthroughs. 

Table 1 lists what we propose are the top 10 major contact lens events of the past two decades. Before you history experts start saying that Table 1 isn't accurate or that it doesn't contain enough events or that the events listed aren't in order, let us assure you that you're correct — there are certainly other events and products that we should consider. We've listed what we believe round out the top 20 contact lens events since 1986 in Table 2.

TABLE 1

Contact Lens Spectrum's Top 10 Major Contact Lens Events Since 1986

 The 1989 FDA decision to reduce approval for soft contact lens extended wear from 30 days to 7 days
 Introduction of disposable contact lenses
 Introduction of daily disposable contact lenses
 Introduction of disposable toric lenses
 Introduction of disposable multifocal lenses
 Introduction of multipurpose lens care solutions
 Introduction of silicone hydrogel contact lenses
 The reassessment of 30-day continuous wear
 FDA approval of overnight corneal reshaping
 The Fairness to Contact Lens Consumers Act

Where We Were

When Contact Lens Spectrum first published in January 1986, the primary advertisements were for Wesley Jessen's Durasoft D3 extended wear contact lenses that claimed unsurpassed Dk/t (32.2), Hydrocurve II toric lenses (Barnes Hind, Inc.), Alcon's OptiSoft and Paragon's Paraperm 02 Plus GP material. The lead news story was a Wisconsin lawsuit settlement of $3.5 million for an extended wear ulcer patient.

In 1987 Johnson & Johnson/Vistakon introduced its Acuvue Disposalens system, and in 1988 Bausch & Lomb added Sequence while CIBA Vision added Newvues disposable lenses. In 1990 CIBA introduced Focus monthly lenses, and B&L launched Medalist four-packs for quarterly replacement.

Later, B&L was sued for offering the same lens for different prices depending upon how many were packaged, and Vistakon was sued because Acuvue and One-Day Acuvue were similar lenses made of the same material. We've always wondered why such practices are acceptable in the food and drug industry but not in the contact lens industry.

In 1990 a survey indicated that 72 percent of wearers wore conventional lenses (what I like to call wear-them-until-they-hurt-get-lost-or-break lenses), 13 percent wore GP lenses and 7 percent wore PMMA, while 5 percent used what were called disposable lenses. Now nearly 90 percent of contact lens patients wear planned replacement or disposable lenses, while only about 7 percent of lenses worn have no replacement schedule. We probably should create another name for this latter type of lens wear. In today's global market conventional lenses are disposable lenses, particularly in monthly replacement (taking into consideration that U.S. patients who wear two-week replacement lenses frequently replace them on a three- to four-week time frame). Perhaps now we should refer to what we once called conventional wear lenses (the wear-them-until-they-hurt lenses) as non-scheduled replacement (NSR) lenses.

In 1987 we estimated that there were 18 million wearers in the United States, and now there are more than 30 million. When Contact Lens Spectrum first published, the estimated number of wearers world-wide was twice that of the United States; it's now probably more than three times that number. Industry sales in 1987 were $1.34 billion and now they're more than $4.5 billion worldwide.

Shaping the Present

Figure 1. Prescribing trends in the US and worldwide.

Disposable Lenses High volume, low cost, highly reproducible contact lens manufacturing, as well as disposable contact lenses, have certainly been the major breakthrough since the early 1970s. Vistakon/Johnson & Johnson's introduction of Acuvue in 1987 was a major event. But despite the company's recommendation at the time that the lenses be used once (hence the technically correct FDA term 'disposable') for seven days of extended wear and then discarded, practitioners changed the paradigm. Whether because of price point or concerns about safety with extended wear, or whether it was the logical extension of planned replacement lenses of that day (mostly quarterly and some monthly replacement), eyecare practitioners increasingly recommended these lenses for two-week replacement in the United States. To this day, although many two-week patients replace their lenses every three to four weeks, two-week replacement prescribing is widespread in the United States.

Many studies have documented reduced complications, especially those related to lens deposits, with the use of disposable lenses.

Early Extended Wear Because of concerns about corneal ulcers, now more commonly called microbial keratitis (MK), with hydrogel lenses and study results published by Poggio and Schein (the CLI sponsored study) in the New England Journal of Medicine in the late 1980s, the FDA issued a statement to eyecare practitioners in 1989 to limit extended wear of soft contact lenses to seven consecutive days from the previously approved 30 days. In the early 1980s, the original FDA approval was for two weeks.

All approvals for GP extended wear, which despite a good safety record has not become very popular, have been for only seven days until Menicon Z received approval in June 2002 for 30 days of continuous wear.

Daily Disposable Lenses Vistakon launched the first daily disposable lenses in 1994. Despite their obvious good ocular health benefits and their popularity in some countries, the UK and Japan in particular, their use remains limited (but is increasing in the United States). This is likely because of cost concerns — by practitioners more so than by patients.

TABLE 2

The Remainder of CLS's Top 20 Contact Lens Events Since 1986

 The introduction of lenses that manufacturers claim are better for patients who report dryness with contact lens wear
 Lawsuits over contact lens patents
 Improvements in cosmetic lenses
 Improvements in corneal topography
 Introduction of silicone hydrogel specialty lenses
 Improvement of semi-scleral and scleral GP lenses
 Consolidation in the contact lens industry
 Improvements in manufacturing methods
 Expansion of material and design offerings
 The growth of contact lens sales globally

Soft Toric Lenses One marvel of modern lens design and manufacturing is the success of soft toric contact lenses. In the early days of soft toric lenses, we commonly used the word "snowflake" to describe their reproducibility because no two lenses of the same prescription were alike. Designs were thicker, of low-water content and unreliable. Now soft toric lenses have much improved designs, and the replication of diagnostic and prescription lenses is incredible. They're still underutilized in favor of spherical lenses or spectacles, and they're often not prescribed to a patient's exact prescription and residual refractive error remains, but they're far more predictable and successful than in the past — so successful, in fact, that they're largely responsible for the continuing underutilization of both spherical and toric GP contact lenses. Figure 1, from the January 2006 article "International Contact Lens Prescribing in 2005" by Morgan et al, illustrates the utilization of lenses by modality in the United States compared to the rest of the world.

Soft Multifocal Lenses Although disposable multifocal contact lens designs haven't proven to be a remarkable breakthrough compared to those of past generations, the availability of large diagnostic lens inventories has fostered growth of multifocal contact lens prescribing. Yet only a few percent of presbyopes wear these lenses, and one-half to two-thirds of presbyopic contact lens wearers still use monovision.

Silicone Hydrogel Lenses Silicone hydrogel contact lens materials are truly a remarkable accomplishment. Following the initial release of B&L's PureVision lens and then CIBA's Night & Day lens, both approved for 30-day continuous wear, practitioners soon realized these lenses were appropriate for all modalities of wear from daily wear with monthly replacement to therapeutic lens use. In fact, both of these lenses have FDA approval as bandage lenses. Manufacturers soon realized that silicone hydrogel lenses designed and marketed for two-week replacement, daily wear or up to seven days of continuous wear (or occasional overnight wear) were highly desirable. Table 3 (courtesy of Carla Mack, OD, FAAO) illustrates the specifications and indications of these lenses.

The arrival of silicone hydrogel lenses brought with it some reports of associated giant papillary conjunctivitis (contact lens papillary conjunctivitis), a condition that compliant use of disposable lenses had nearly eliminated.

The promise of safer 30-day continuous wear using silicone hydrogel has been the focus of much research and discussion. There's no question that silicone hydrogel materials have largely eliminated hypoxia-related complications, but surface-related, patient compliance and perhaps tear stagnation issues remain. We see infection and toxicity-related infiltrative keratitis with these lenses that we previously attributed to hypoxia. Although keratitis still occurs at a low rate, most patients who wear these lenses have very clear corneas and conjunctiva.

Despite the fact that many hypoxia-related signs, such as corneal swelling and limbal vascular response, are limited with silicone hydrogel extended wear, recent reports indicate the rate of MK with silicone hydrogels is similar to to that of hydrogel lens wear, but the results on the severity of the outcomes of these infections (loss of vision) are still uncertain. Although many patients would like to sleep while wearing their lenses and many of them do, we have yet to see a growth in prescribing extended or continuous wear with either silicone hydrogel lenses or with Menicon Z GP lenses.

As things stand in mid-2006, silicone hydrogel specialty lenses are becoming and will become increasingly available in the form of toric and multifocal lenses.

CONTACT LENS TIMELINE 1986 - 2006

JANUARY 1986 Contact Lens Spectrum founded by Neal Bailey, OD, PhD
OCTOBER 1987 First US Disposable CL
MAY 1989 FDA Issues Dr. Doctor letter changing extended wear from 30 days to 7 days
1994 First US Daily Disposable CL
APRIL 1998 Proclear lens receives FDA approval for CL Dry Eye recommendation
FEBRUARY 1999 Bausch & Lomb PureVision silicone hydrogel lens receives FDA approval for 7-day extended wear
OCTOBER 2000 CIBA Vision acquires Wesley Jessen
OCTOBER 2001 CIBA Vision Night & Day silicone hydrogel lens receives FDA approval for 30-day continuous wear
JUNE 2002 Paragon CRT receives FDA approval for overnight wear
JULY 2002 Menicon Z GP lens receives FDA approval for 30-day extended wear
FEBRUARY 2004 Fairness to Contact Lens Consumers Act enacted

We wonder if the silicone hydrogel to hydrogel lens usage ratio by the end of this decade will be greater than 50/50. Time will tell. Cost, lens quality, marketing and future unforeseen developments will no doubt play a role.

Corneal Reshaping FDA approval of overnight corneal reshaping first for Paragon's Corneal Refractive Therapy and later for B&L's Vision Shaping Treatment systems was exciting. But most practitioners seem reluctant to perform the procedure and patient awareness is low. Although results are largely favorable, there is some concern about infection rates and especially the safety of children and teens when using these treatments.

Multipurpose Solutions When Contact Lens Spectrum first published, multipurpose soft contact lens care solutions were new. I remember talking with Brien Holden, PhD, DSc, FAAO, about how we didn't think patients would ever comply with this type of lens care that required rubbing and rinsing their lenses and then soaking them in a clean case. Plus multipurpose solutions seemed at that time to have limited antimicrobial effectiveness compared to hydrogen peroxide, which was used by approximately three-fourths of wearers at the time.

Fairness to Contact Lens Consumers Act After many years of speculation and failed legislative attempts, the Fairness to Contact Lens Consumers Act (FCLCA) passed in 2004. Paranoia that a higher number of patients would purchase their lenses from sources other than their prescriber proved to be just that. Earlier this year, legislation supported by 1-800 Contacts passed in Utah that will require manufacturers to sell to all channels of trade. Lawmakers have proposed similar federal legislation as well.

Notable Events and Trends: 1986 to 2006

Initially introduced by Biocompatibles, which CooperVision later acquired, the Proclear Compatibles lens containing phosphorylcholine is the only lens to acquire an FDA indication for patients who have dry eye symptoms. Manufacturers have since tried for the FDA indication with other lenses that they claim are better for people who have dry eyes, but the FDA has been reluctant to provide it. Still, many manufacturers continue to suggest that their lens is a good one for this type of patient.

Another current trend is for solution manufacturers to emphasize the importance of preventing dryness symptoms while both lens and solution manufacturers demonstrate that their products are better for late-day comfort. Clinicians are reinvestigating the whole issue of dry eye, with a recent major focus on surface effects of contact lenses.

CIBA successfully defended its Harvey patent for silicone hydrogel lenses, which kept B&L out of the market for some time. While such legal activity may continue, competition in this field will increase — which will be good for us all.

Top Three CL Milestones
By H. Dwight Cavanagh, MD, PhD

Contact lenses have come a long way in the past 20+ years. I think chronologically that the first important milestone was the introduction of extended wear lenses in the early 1980s and the Hilton Head Conference of 1986, which dealt with the ensuing infections issue and resulted in the classic Poggio-Schein papers in the New England Journal of Medicine that first defined risks of microbial keratitis (MK) by lens type and wearing mode.

Next came the introduction of disposable lenses in the late 1980s, which helped the GPC problems but did not (as expected and hoped for) reduce risks for MK (Chen et al, 1999).

Most recently, the realization that hyper-Dk/t lenses — both GP and silicone hydrogel — are much better for ocular health, and may indeed reduce infection risks, has led to a new renaissance for safer extended wear.

My jury is out, however, on the merits of the revival of orthokeratology. In addition, important future research needs to tell us if orthokeratology influences the natural progression of myopia.

All in all, it's an exciting time in contact lenses!

CIBA acquired Wesley Jessen in 2000, and the company and others have delivered many improved cosmetic lenses. In 2005 sales of these lenses decreased relative to increases of previous years. Compared to what was available 20 years ago, these lenses offer a nearly endless number of options for patients who want to change their appearance through changing or enhancing their eye color.

The wider availability of improved corneal topography systems has paved the way for more effective corneal reshaping with contact lenses as well as for diagnosis and treatment of irregular corneal abnormalities. The hope of past years that corneal topography linked to GP lens fitting would spur GP lens use is largely unfounded to date.

A plethora of designs is available in semi-scleral and scleral GP lenses, which have helped us and will continue to help us fit irregular corneas. More carefully documented research and clinical reporting is needed in this area to determine long-term viability of these designs in high-Dk GP materials.

Consolidation in the contact lens industry has and will continue to occur. Alliances have taken shape over the past few years that heretofore would have been unimaginable, and more will come in the future.

Certainly the improvements in manufacturing methods for all contact lenses — from disposables to daily disposables to mass produced GP lenses and reverse curvature lenses to aberration-control lenses — have greatly impacted our industry. Twenty years ago these options were still in their early stages of development, while today they're commonplace. The newer lens designs in addition to improved high-volume, quality manufacturing methods all combined with higher-Dk materials make the hand-made PMMA and low-Dk GP lenses and lathe-cut HEMA lenses of the past seem like antiques.

Where We're Headed

We learned some time ago when we did our contact lens of the future issue in 1987 that it's hard to predict the future. So here are some suggestions that we believe would be nice if they did happen:

• Disposable lenses customized for each patient's exact prescription. Yes, the full prescription, in a stable lens that corrects even low cylinder and specific spherical aberration needs.

• High Dk/t lenses and lens care systems that offer better surface results and contact lenses or lens-and-care systems that prevent infection. We've said this before and it's under investigation, but it's easier said than done.

• It seems logical that as time goes by, contact lens replacement cycles will become less artificial (one day, two weeks, etc.) and will rather be customized to each patient's needs.

• GP extended wear inventory lenses with good comfort and efficient fitting.

• We'd like to predict a more successful multifocal lens design, but reality too often sets in. In the meantime we can only hope that practitioners will become more likely to use the many designs in the good materials that we now have.

TABLE 3
Silicone Hydrogel Sphere Properties

 

NIGHT & DAY

BIOFINITY (2006)

ACUVUE OASYS

O2OPTIX

PUREVISION

ACUVUE ADVANCE

Manufacturer

CIBA Vision

CooperVision

Vistakon

CIBA Vision

Bausch & Lomb

Vistakon

Material

Lotrafilcon A

Comfilcon A

Senofilcon A

Lotrafilcon B

Balafilcon A

Galyfilcon A

Dk

140

128

103

110

101

60

Dk/t

175

160

147

138

110

86

Water (%)

24

48

38

33

36

47

BC (mm)

8.4, 8.6

8.6

8.4

8.6

8.6

8.3, 8.7

Surface

Plasma tx

No surface treatment

Hydraclear Plus

Plasma tx

Plasma tx

Hydraclear

Replacement

1-month DW
1-month CW

Monthly

2-week DW
1-week EW

2-week DW
1-month CW

1-month DW

2-week DW

Therapeutic
Approval

Yes

No

No

No

Yes

No

UV

No

No

Yes

No

No

Yes

FDA Group

I

I

I

I

III

I

Modulus

1.52

0.75 0.72 1.00 1.50

0.43

Paying Tribute to CLS Founder Neal Bailey, OD, PhD

"I have known Dr. Neal Bailey for more than 30 years as a friend and colleague. Wrapped in a personality of wry wit is as sharp a questioning mind about the biology of contact lens wear as ever existed. His direct contributions scientifically are exceeded only by his inspiration as a role model for at least two generations of students. All in all, a man for all seasons. " H. Dwight Cavanagh, MD, PhD

"All eyecare practitioners who have ever fit a contact lens have benefited directly or indirectly from Dr. Neal Bailey's involvement with both the practice of contact lens fitting and the contact lens industry. Congratulations and thanks to Dr. Bailey for the inspiration that has provided for more than 20 years a 'forum' for the presentation of research and information on the ever changing 'contact lens spectrum." — William J. Gleason, OD

Contact Lens Spectrum is a journal initially led by the doyen of optical industry correspondents: Neal Bailey, OD, PhD, — story tracker, analyst, straight-shooter." Brien Holden, PhD, DSc, FAAO

"When large discount optical chains were perceived as a threat to some practices, Neal Bailey inspired colleagues to aim high and reminded them that quality will win over quantity as well as 'There's always room at the top.

Dr. Bailey also believes that silicone is the lens material of the future (and always will be)" Michael A. Ward, MMSc, FAAO

"A self-effacing, open-minded person whose affable personality belies a penetrating intellect, Neal Bailey has been a unique catalyst for bridging the diverse constituencies of the contact lens arena and has created a legacy that will resonate far into the future." — Perry Rosenthal, MD

Dr. Barr is a professor and associate dean for clinical services and professional program at The Ohio State University College of Optometry.

We wish to thank William J. Gleason, OD, FAAO, Thomas G. Quinn, OD, MS, FAAO, and Carla J. Mack, OD, FAAO, for their help with this article.



Contact Lens Spectrum, Issue: June 2006