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