FTC Workshop: The Contact Lens Rule and the Evolving Contact Lens Marketplace

March 7, 2018

Segment 1

Transcript

ALYSSA BERNSTEIN: Good morning. My name's Alyssa Bernstein. And I'm an attorney in the 

Bureau of Consumer Protection Federal Trade Commission. On behalf of my colleagues, I'm 

very excited to welcome you all to the Contact Lens workshop. We're excited to explore the 

contact lens marketplace with you today. Before we get to the main event, I need to review a few 

administrative details, so I hope you've had your coffee already, 

Please silence any mobile phones and devices. If you need to use them during the workshop, 

please be respectful of the speakers and your fellow audience members. Be aware if you leave 

the Constitution Center building for any reason during the workshop, you're going to have to go 

through security again. Keep this in mind and plan ahead, especially if you're participating on a 

panel so that we can do our best to remain on schedule. 

The restrooms are just outside the auditorium. The plaza east cafeteria is located inside the 

building. So you can use it without going through security. The cafeteria is the place to go if you 

like coffee or tea without having to leave the building. It's open till 11 AM, and then we'll reopen 

at 11:30, and remain open till 3:00 PM. There's no food or drink other than water permitted in 

the auditorium. 

Most of you received a lanyard with a plastic FTC the event security badge. We reuse these for 

multiple events, so when you leave the day, please return your badge to the event staff. If an 

emergency occurs that requires you to leave the auditorium but remain in the building, follow the 

instructions provided over the PA system. 

If an emergency occurs that requires the evacuation of the building, the alarm will sound, and 

everyone should leave the building in an orderly manner through the main 7th Street exit. After 

leaving the building, turn left, and proceed down 7th Street, and across East Street to the FTC 

emergency assembly area. Remain there until instructed to return to the building. If you notice 

any suspicious activity, please alert building security. 

Be advised this event may be photographed, and it is being webcast, and recorded. By 

participating, you are agreeing that your image and anything you say or submit may be posted 

indefinitely at FTC.gov or one of the commission's publicly available social media sites. 

Welcome to those watching via the webcast. We'll make the webcast and all of the workshop 

materials available online to create a lasting record for everyone who is interested in these issues. 

For those of you on Twitter, we'll be tweeting today's workshop at #ContactLensFTC. If you'd 

like to ask a question via Twitter, please tweet your question using that hashtag. 

We'll also be accepting questions via paper cards. They look like this, for those who are here in 

the audience. You may have picked up some of these cards already at check in. Workshop staff 

will also walk around and distribute these cards during each session. And then we'll collect the 
cards, and bring them up to the moderators. Due to time constraints, we will not be able to 

address all questions during the workshop itself, including those we receive via Twitter, but 

workshop staff will certainly review all of the questions. 

If you'd like to submit a formal written comment about issues that we discussed at the workshop, 

we welcome online submissions at the FTC's website through April 6. If you need anything 

during the conference today, please feel free to ask FTC staff who are wearing the official 

workshop badges, including the paralegals who greeted you at the registration desk. 

Lastly, I want to thank our panelists for taking part in today's workshop. We're grateful for your 

time. Aside from the people you'll see on stage today, the program would not be possible without 

the great work of Crystal Peters and Bruce Jennings, the honors paralegals that have been 

helping you throughout the day, the assistance of our college interns, Jennifer Thompson and 

Breanna Thomas. Also providing invaluable support are Nathan [INAUDIBLE], from our 

Division of Consumer and Business Education, Nicole Jones from Office of Public Affairs, and 

Bonnie McGregor from our Division of Advertising Practices. 

Now it's my honor to introduce our acting director of the Bureau of Consumer Protection, Tom 

Pahl, to get opening remarks. He oversees the commission's attorneys, investigators, and 

administrative personnel working to protect consumers from unfair and deceptive practices in the 

marketplace. Tom first joined the agency in 1990, and spent more than two decades serving in 

various positions, including as an attorney advisor for former FTC commissioners, Orson 

Swindle and Mary Azcuenaga, and as assistant director in the division of Financial practices and 

advertising practices. 

In his position as Assistant Director of Advertising Practices, Tom oversaw the commission's 

work on the contact lens rule, so he's definitely not a stranger to many of the issues we'll be 

discussing today. Welcome, Tom. 

TOM PAHL: Well, thank you, Alyssa, and good morning, everyone. I'm Tom Pahl, the acting 

director of the FTC's Bureau of Consumer protection. Welcome to the FTC workshop on the 

contact lens rule and the evolving contact lens marketplace. It's great to see so many people here 

getting together on a topic that affects so many Americans. In fact, more than 41 million 

Americans, more than 16% of the United States population, wear contact lenses, and that number 

is growing. 

In 2002, just prior to the creation of the contact lens rule, about 13% of Americans wore 

contacts-- 5 million fewer than today. And that growth may be accelerating. According to one 

industry tracker, the vision counsel, who will be one of our panelists today, 1.3 million more 

Americans are wearing contacts now than 12 months ago. Contact lenses are also a major 

purchase for many consumers, with many spending hundreds of dollars a year on lenses. 

Besides the benefits that consumers quite literally see, contact lenses are a big business. US sales 

revenue surpassed $5 billion last year, up from less than $2 billion in 2002. The variety of lenses 

and of places to buy them is far more diverse than it once was. Consumers can now choose from 
online sellers, big box stores, wholesale clubs, retail chains, and of course, from independent eye 

doctors. 

We at the FTC liked to think that the contact lens rule has contributed to the growth and diversity 

of the contact lens rule marketplace. The rule has been in place since 2004, but it's worth 

reviewing its history in the statute that provides the framework for the rule. I'm particularly wellsuited, as Alyssa had mentioned, to discuss the industry because I was one of the FTC staff 

members who worked on promulgating the original rule in 2004. 

Often, what people think of as requirements imposed by the FTC through the contact lens rule 

are actually requirements spelled out in the statute. Specifically, the Fairness to Contact Lens 

Consumers Act, or FCLCA, which went into effect in 2004. At the time of the act's passage, 

about two thirds of the states already had statutes requiring some form of prescription release to 

consumers. 

Yet despite these laws, Congress determined that many consumers were still not getting copies 

of their prescriptions, and were having a tough time obtaining lenses from third party sellers due 

to prescription verification obstacles. Problems with prescription release and verification 

hampered competition, and limited the ability of consumers to comparison shop. Congress also 

had concerns that some sellers were selling lenses without requiring a valid prescription. 

The act was intended to remedy these concerns. Foremost is what's known as the automatic 

prescription release requirement, which mandates the prescribers give consumers a free copy of 

their prescription at the end of a contact lens fitting, even if the consumer doesn't ask for it. They 

act further provides that consumers can take prescription to any seller to be filled. Because it's 

not always possible for consumers to present an actual copy-- perhaps the consumer lost the 

prescription or wasn't given it-- the act also requires the prescribers verify prescriptions. 

In the act Congress, opted for a framework that includes three possible methods of obtaining 

verification. A prescription is considered verified if first, the eye doctor confirms the accuracy of 

the prescription. Second, the eye doctor corrects inaccuracies in the prescription. Or third, the 

doctor fails to respond to the verification request within eight business hours. This third method 

is commonly known as passive verification. 

In constructing the verification framework this way, the idea was that prescribers can prevent 

consumers from using an invalid prescription, and there are sound medical reasons for doing so. 

But prescribers also would not be able to block third parties from selling to consumers simply by 

ignoring a third party's verification request. The act also makes it illegal to sell lenses without 

either verifying the prescription, or obtaining a copy of the consumer's prescription. It also 

prohibits Sellers from altering a prescription or switching to prescribed brand. 

The heart of the act is automatic prescription release, and passive verification. We can, and will 

talk today about whether these are working as intended. But to substantially alter these 

requirements would require legislative action. It's not something the commission has the 

authority to do by rulemaking. 
Today, our focus is primarily on the contact lens rule, which the commission issued in 2004 to 

implement the act. The rule tracks a statute very closely with the same requirements the 

prescribers release and verify prescriptions, and don't charge extra for doing so. The rule also 

contains some additional provisions, such as a record keeping requirement for sellers, a 

definition as to what constitutes eight business hours, and a requirement that during the eight 

hour period, a seller has to provide an opportunity for the prescriber to communicate with them. 

Which brings us to the current rule review. In September 2015, as part of our periodic regulatory 

review process, the commission sought public comment on the contact lens rule. How it was 

functioning, whether it was still needed, its benefits and its burdens. In response, the FTC 

received 660 comments. Virtually all of them agreed that there is a continuing need for the rule, 

and that it benefits consumers and competition. 

At the same time, many commenters also recommended the commission make modifications to 

the rule. Some felt that sellers and consumers were abusing the passive verification system to 

avoid seeing their eye doctor, and were getting lenses without a valid prescription. Other 

commenters said the verification request, robocalls in particular, were a burden on doctors. Yet 

other commentators said that even after more than a decade, many prescribers were still not 

releasing prescriptions. Some released them, but only if patients requested them. Others never 

released them at all, instead steering patients into doctor owned optical shops for their contact 

lens purchases. 

After viewing all the comments, surveys, and other information that was submitted, the 

commission decided in November 2016 that there was need for improved compliance with the 

rule's automatic prescription release requirement, as well there's a need to create a mechanism for 

monitoring and enforcing the rule. To accomplish this, the commission proposed to amend the 

rule to require that prescribers obtain a side acknowledgment form from patients, confirming that 

they had received prescribers. Prescribers would have to hold onto these signed receipt for three 

years. 

The commission believes these changes would lead to increased prescription release, which in 

turn would improve compliance with the rule. Increased prescription release would enhance 

patient flexibility and choice, reduce costs for patients, sellers and prescribers, and reduce 

consumer harm from verification errors. The commission believe that these benefits exceeded 

the burden of one minute per patient that it had estimated it would take to obtain a signed receipt, 

and save into the patient's file. 

In response to this proposed amendment, we received over 4,000 comments, including more than 

800 from eye doctors alone. While many commenters supported the proposed amendment, the 

comments raised many issues the commission decided deserved additional attention and 

examination. The optical marketplace is evolving in many ways with new developments in 

telehealth, patient portals, online and subscription delivery models, as well as developments in 

the types of lenses that people wear. As just one example, less than 8% of consumers use daily 

disposable lenses in 2005. Nearly 30% use them in 2017. And as many as 50% are projected to 

use them by 2021. 
In light of the changes to the market, and the comments we received, the commission has 

decided to hold the workshop that we are going to have today. We've assembled a great group of 

panelists that include optometrists and ophthalmologists. Online sellers, brick and mortar 

retailers, academics, consumer advocates, economists, and of course, one or two lawyers, 

because you can never have a panel in Washington without lawyers. 

Today, we'll have six panels. We'll start with a short look at the marketplace. Then move on to 

discuss health and safety. And then competition. After lunch, we'll resume with a panel 

examining verification, followed by a panel on facilitating consumer choice. We'll wrap up with 

a panel looking ahead at developments and disruptions that may be coming down the pike. 

By having these discussions today, we hope to educate ourselves about changes in the 

marketplace that may create opportunities for consumers to obtain contact lenses safely, and at 

competitive prices. We'll also explore how the contact lens rule can foster competition, maximize 

consumer benefits, and minimize burdens on prescribers and sellers. 

So let me thank our panelists for agreeing to share their knowledge and experience with us. I 

know some of you have come great distances to join us here today, and we appreciate it very 

much. And let me also thank everyone who couldn't make it in person, submitted comments in 

advance, or is joining us via online. We read all comments that we receive, and take them 

seriously. 

Finally, I want to thank the FTC staff from the Bureau of Consumer Protection, the Bureau of 

Competition, the Bureau of Economics, and the Office of Policy Planning, who have worked so 

hard and well put this workshop together. The fact that this workshop draws from all the 

different parts of the FTC, to me, really speaks to the breadth the issues, their complexity, and 

the importance to the agency. And so I've been thrilled to see that our staff folks have been able 

to work together to make sure that the expertise of all parts of the agency are brought to bear on 

the issues that we're going to discuss today. 

So with that, I'm going to turn the podium over to Beth Freeborn and the first panel to get us 

started. Thank you everyone, and have a great day. 

BETH FREEBORN: All right. So prior to discussing some of the issues that are currently facing 

the contact lens market, this panel is going to provide a general overview of the current market, 

and discuss how things have changed since the contact lens rule was enacted in 2004. I want to 

begin by introducing and thanking our two great panelists who have both done quite a bit of 

work to prepare information for this panel. 

First, we will have Steve Cody, who is the Senior Director of Industry Research Services at 

division counsel. Steve will be providing information largely from the consumer side of the 

market. And next, we have Wally Lovejoy Lovejoy Eye Care Consulting. Wally has had 

numerous jobs in the eye care industry, and brings a wealth of knowledge to this panel. So 

gentlemen, thank you very much for being part of this panel, and let's start with Steve. 
STEVE CODY: Thanks, Beth. As she mentioned I worked for the division counsel, and we're 

basically a nonprofit organization that serves as the global voice for eyewear and eye care. We 

have a large variety of member companies, from small family owned businesses to large 

corporate companies. And we generally try to provide them with information that helps them run 

their companies better, more efficiently. Whether that's research, training, industry, networking 

events. Moreover, with access to eyewear trends, the latest advances in technology, and advice 

from experts in the industry. We also serve the public who are looking for more information 

about eye glasses, sunglasses, eyewear, and eye care. 

And a big part of our research portfolio is our vision watch consumer survey program. It's a 

continuous study that interviews over 10,000 American adults per month, asks them all sorts of 

questions about eyewear, and eye care, including quite a bit about contact lenses. So I'm just 

going to give you guys kind of an overview of the data that we have there, and the trends that 

we're seeing, not just in 2017, but comparisons to 10, 13, 15 years ago, as the data permits. 

Kind of talk about a trend here. Thomas mentioned a few of the statistics about there's 41.4 

million US adults wearing contact lenses in the US. That represents about 16.4% of the 

population. Is also about 3.9 million juveniles under the age of 18 wearing contact lenses. Up as 

well. The or million user increase last year is just part of the growth that we're seeing for contact 

lenses. In fact, over the past 13 years, we've seen an increase of about 10.1 million users using 

contacts, at least some of the time. That's growing faster than any other type of vision correction 

method or modality in the United States. 

About 40% of those users just wear contacts exclusively, no other types of eyewear. The other 

60% are wearing them with glasses or over-the-counter readers, things of that nature in 

conjunction. Really, about 25% of adults 18 to 34 wear contact lenses. That's almost half of the 

population wearing lenses. And that's up 52% over the past 13 years. But in terms of relative 

increases, there's been over a 100% increase in the people over the age of 45 wearing contact 

lenses since 2013 thanks to the introduction of a lot more multifocal presbyopic contact lens 

solutions that have been introduced into the marketplace. 

But we've seen growth among people from higher income households, people from the Northeast 

region of the country, people who have insurance and manage vision care coverage, MVC--

you'll hear that term a lot today. And those numbers are growing. 

For the most part, a majority of wearers-- 19.7 million-- wear lenses all day, but not while 

sleeping. That's up 41% over the past 13 years. You have about 11 million users wearing contact 

lenses all day, including while sleeping. That's also up significantly. But the biggest increase is 

in occasional users just wearing them for a specific functions. That's up by about 67% over the 

past 13 years. And there's about 7.3 million of those users usually working with eye glasses or 

reading glasses, and over the age of 45. 

As Thomas mentioned, there's a variety of places where consumers can get their contact lenses. 

Just to give you a perspective, the industry generated about $40.4 billion in total sales last year. 

That's only up by a tenth of a percent from the previous year. But contact lens were up 4.5% over 
the past year. Up 7.5% over the past two years. And really, growth kind of spread amongst the 

different distribution channels. Independent ECPs. Wally will kind of talk about that later. 

The small independently owned practices by optometrists, opticians, ophthalmologists with three 

or less locations. Generated almost $2 billion in sales thanks to a customer that's more medically 

oriented, generally older, from a higher income household, with insurance leading the market 

there. But also losing share-- we'll see in a minute-- to some of those other channels. 

Mass merchants, conventional chains, big box retailers also selling a good number of contact 

lenses, growing by about 3.7% to 4.2% over the past year. And then you have the online channel. 

Kind of more commodity, fashion oriented customer, younger, from a higher income household. 

Already buying things online. They almost sold about $800 million worth of contact lenses last 

year, only growing by about 5%, which is the smallest amount of growth that we've seen from 

that channel recently. And we'll kind of talk about the long term trend there in a second. 

Wally will talk about the landscape for the retail community there. We've seen an increase of 

about 10% in number of independents selling contacts over the past 10 years that's a 

corresponding to a 34% increase in revenue for the independent ECP selling contact lenses. 

And generally, through vision watch, the great thing about consumer studies-- you can ask them 

all sorts of questions about behavior. And generally, for the 38 million US adults that wear 

contact lenses exclusively or in conjunction with eyeglasses, they choose to wear contact lenses 

for three reasons. First is cosmetic. They feel they look better in contact lenses. Second is 

convenience. It's easier than taking on and off eyeglasses. 

The third is generally also related to convenience, but the fact that many consumers, generally 

younger, male, people who are outside a lot, participating in sporting activities, they think that 

eyeglasses won't fit with their active lifestyle. So those are generally the three reasons why 

people choose to wear contact lenses over eyeglasses. 

Now there's about 41.4 million people who do wear contact lenses in the US. There's about 48.8 

that were wearing them at some point in the past, but have stopped for various reasons. And 

again, the reasons why people choose to stop wearing contacts generally come down to one of 

three things. First one, discomfort. About 44% of all the people that we surveyed stopped 

wearing contact lenses. Or 41% because of discomfort. About 30% stopped because of 

convenience, basically. Easier to wear glasses. You hear that, especially from daily contact lens 

wearers that stop wearing. And finally, dry eyes. About a quarter of the people that stop 

worrying use that reason in particular. 

And the contact lens business has gotten a little bit better at preventing people from walking 

away from the market with advances in technology and product. When you compare the number 

of people who've walked away from the market now compared to 10 years ago, there's fewer 

people leaving the market for discomfort, inconvenience, visual acuity or clarity problems, 

perceived price concerns, the need for a multifocal or presbyopic solution. You're seeing more 

people walk away now just because of dry eye issues or because they've had a surgery procedure 

to fix their vision problems. 
This looks at the long term trend lens sales out there. As I mentioned before, there's been about a 

32.4% increase in usage over the past 13 years. There's been a 41% increase in the number of 

transactions that those users use, the purchases of contact lenses on an annual basis, up by 41%. 

And the revenue that's brought in by 67% over the past 13 years. And again, distribution by 

channels vary considerably. Independents losing share here over the past 13 years, but still 

growing aggregate sales by almost 59% over the past 13 years. The conventional chains growing 

their sales by about 70%. The mass merchants by almost 80%. 

The online retailers growing by about 160% over the past 13 years. That's about 10.7% a year on 

average. And what we're seeing now is about 85% of those online customers are repeat 

customers who purchased in the past. And 15% are walkouts who previously bought from a brick 

and mortar location. And we'll talk a little bit about that in a few seconds here. 

Through Vision Watch, we collect pricing information, but it's a little different than what most 

people would consider as list price or original price. We track the out-of-pocket paid price by the 

consumer, what's coming out of their pocket to buy the product that they want. So there's a lot of 

things missing in that equation. 

We're missing the rebates from the manufacturer, the retailer. We're missing a lot of packaging 

and bundling discounts that occur. Managed care influence, people using tax deferred plans, or 

discount plans. We're not catching that in our data, but we are tracking what people are paying 

out of their own pocket. And even though it's a little different from what we're seeing from some 

other pricing sources there, what we're showing is that consumers are paying more out of their 

own pocket for the contact lens that they're buying. 

Particularly, they're spending about $51, $52 per transaction out of their own pocket when 

buying contact lenses. And on an annual basis, that means they're spending about $121 on just 

the contact lens that they're buying. And the cost or price per transaction in aggregate up by 

about 22% over the past 13 years, growing by about 1.7% annually. The entire annual spend up 

by 31% over the past 13 years, grown by about 2.4% annually. 

And there's some differences there based on consumer demographic. Basically, adults over the 

age of 35 paying more now than they were 13 years ago. And also increasing the amount they 

pay. Consumers under the age of 35 generally flat. People with insurance benefits also spending 

more now than they were a few years ago, and some of that might be tied to the benefits, and the 

allowable benefit for people that have eyeglasses and contact lenses. Sometimes, they're 

spending money on contact lenses out of their own pocket. 

Managed Vision Care does have a huge influence on both the industry as a whole for vision care 

and optics, but especially for contact lens. We have about 126 million US adults that have some 

type of vision care or insurance coverage when they go to buy optical products. That's up by 14.5 

million from December of 2007 before the recession set in. The people using Managed Vision 

Care to buy contact lenses is up by 61% over the past 10 years. About a quarter of those folks are 

using some type of stand alone Managed Vision Care care plan, VSP, IMED, Spectera, so on and 

so forth. That's up by 5.6% over the past year. It's up by 65% over the past 10 years here. 
And again, performance varies based on the channel you're looking at. About 61% of all the 

contact lens sales involving insurance of some sort happened at an independent ECP. Compare 

that to the 39% share of the total contact lens sales, and you can see how the independent 

practitioner depends on insurance a lot for their contact lens business. 

About 17% of all MVC sales happened at a chain location, about 15% at a mass merchant 

location. And really, the growth over the past 15 years has been skewed towards the 

independents as well. In aggregate, the number of contact lenses that are selling with managed 

care are up 75%. All the other channels and outlets only up 35% combined in aggregate. 

And when you look at the type of consumer that's using Managed Vision Care, it generally lies 

more on men, adults between the ages of 35 to 54. People from higher income households. And 

people who are just wearing contact lenses as their only means of vision correction. 

We'll take a look at some of the attributes of people wearing contact lenses in the US. About 

9.6% are currently wearing some type of rigid or semi-rigid lens. That's up 25% since 2007, 

thanks to more people from higher income households, people over the age of 45 wearing rigid 

or semi-rigid lenses. Toric lenses. About one out of every six or so contact lens wearers are using 

toric lenses. That's actually down a bit from 10 years ago. The multifocal users up by about 30%, 

again, thanks to that influx of relatively older users over the age of 45. 

There's some other attributes. There are about 10.5% of contact lens wearers are only wearing 

the lens in one eye. About 12.2% percent wear them to enhance or change the color of that. But 

the biggest change, as Thomas mentioned before, is in modality usage. You have about 29% of 

the US adult population wearing daily lenses. About 22% wearing weeklies. Almost 40% 

wearing monthlies. And then finally, just under 10% wearing a long term speciality custom or 

gas permeable lens. 

Since 2007, the number of disposable users up 275%, most of them in the younger age 

categories. Monthly usage also up over the past 10 years, but not nearly as much. And most of 

that has come at the expense of weekly, biweekly wearers and fewer custom long term wearers 

as well. 

One of the things that we noticed through Vision Watch is that consumers unfortunately, some of 

them don't abide by the recommended replacement frequency. You have about 10% of all daily 

lens wearers in about 12% of all total contact lens wearers not abiding by the prescriber or the 

manufacturer recommended replacement frequency. Typically, you see younger adults, people 

from lower income households without insurance, people that are new to the category-- they're 

more likely to extend the use of lenses beyond the recommended replacement frequency. And 

fortunately, what we're tracking going back to 2011, there are fewer people now that are 

disregarding those replacement frequencies and more people abiding by it today. 

You look at eye exams out there-- about 114.9 million exams are conducted in the US over the 

course of 2017. That's flat compared to 2016. There were 34 million contact lens exams over the 

course of the year. Up by 3.1%, meaning about 80% of the people that wear contacts got an eye 

exam last year. It was one of the few bright spots for the eye exam industry. 
And what we've also found is that about 63% of those exams happened at an independent ECP 

location. When you compare that to the 39% of lenses bought at an ECP location, you can see 

there's a pretty high walkout rate. People that take their prescription and go elsewhere with it to 

make a purchase. 

And generally speaking, about 46% of those folks will go to an online retailer, either an online 

only retailer without a brick and mortar presence, or a reorder site from a brick and mortar site. 

About 20% will go to a mass merchant brick and mortar location. 16% to a chain. 10% to a 

wholesale club. 5% to another independent ECP. And one of the things that we've noticed since 

2007, the number of people going directly to an online retailer has more than doubled, from 22% 

of walkouts to 46%. 

And they're generally younger, higher income, already buying things online, whether it's food, 

apparel, other items. And generally speaking, they're also more of a commodity fashion oriented 

customer. And this is really one of the big driving factors that we're seeing behind the industry 

there. So that's basically the slides that I had there. I don't know if we're going to do questions 

now or wait. 

BETH FREEBORN: We'll wait. 

STEVE CODY: OK. Cool. Sure. 

WALLY LOVEJOY: Good morning, and let me introduce myself. As Steve suggested, he has a 

great deal of statistical data supported by a big organization. The information I'm going to share 

with you is really, my amalgamation of reading lots of data about the industry from Vision 

Counsel, from Jobson, from AOA, and [INAUDIBLE] data that are published in trade press. 

And I have tried to put together a few slides that will allow me to draw big picture, but I have not 

put in footnotes. For those lawyers that really like footnotes, if you want my sources, or if you 

question the data, and would like to offer the FTC better data than what I am going to be 

summarizing for you here, I know they would welcome it, as would I. 

I am an independent contractor. I'm here on behalf of the National Association of Optometrists 

and Opticians, which means they're paying my expenses to be here. I am not representing them. I 

think most of what I'm going to be presenting is either objective data or my opinion about how 

the objective data fits together, but I'm not speaking on behalf of any of the members or the 

association. This is my interpretation of the information I'll present. And I do think that there is a 

great deal of information out there from all of the manufacturers, trade associations, and 

professional associations that hopefully, I have captured accurately here. 

One of the things I was asked by Beth to talk about is who's prescribing out there now. And most 

recent data I've seen is that there are nearly 43,000 US optometrists and 16,700 

ophthalmologists, all of whom can prescribe contact lenses. Over 12,000, maybe 12,500-- those 

optometrist or affiliated with optical retail chains. 11,300 locations. Most of those optometrists 

do not sell the products that they prescribe, including contact lenses. 
And I'm going to make an assumption that just by my look at the Vision Monday report of the 

top 50 optical retailers, that 12,500 ODs and those 11,300 locations doesn't include optometry 

led alliances, franchises management service agreements. So that would be brands like Vision 

Source, my eye doctor, Eye Care Partners, and others. Where the way that the data has been 

defined is an optometrist who makes the professional judgments at three or fewer locations is an 

independent. But they typically prescribe and sell product in those groups. 

And so I think that those brand names or trade names that I just mentioned are typically included 

in the 26,000 optometrists that are involved in private practice. So you can query whether 

semantics makes sense, that it's private, if you're getting a lot of help from a franchise, or a 

management service agreement. But the independent professional judgments are owned by the 

OD who owns the practice. And they may pay royalties or management service fees for the help 

that they get from the nonprofessional side of the business. 

There have been changes in the supply of optometrists and in the number of eyewear retail 

locations over the years. I think it's appropriate, as Mr. Pahl suggested, that more competition has 

supported that. In 1975-- and this data is from the early eyeglasses one report, that the FTC 

studied the market before the initial eyeglass prescription release requirement, and the review of 

some of the advertising restrictions that were in the market at the time, there were about 20,000 

active ODs. 85% of them are self-employed. And most of the other optometrists are employed by 

other ODs. 

With the rise of commercial free speech and eyeglass prescription release, the market started to 

change. At that time, ODs did only about 29 million eye exams, which was 57% of the 51 

million that were done that year. And optometrists' involvement in eye exams and primary eye 

care continues to grow after eyeglasses one rule, and the commercial free speech opening. The 

number of doctors continued to grow, but the percentage in private practice went down. So that 

by 1986, only 73% were in private practice. 

And by 2003, the number of independent prescribers had grown to 22,500. But a number of other 

retail locations with that had grown to 16,500. So advertising and some of the other changes that 

went on as a result of state law changes relating to things like brand names, and commercial or 

mercantile locations, department store locations began to open up a little bit more. So it became 

easier for optical retailers like NAOO members to have sublease or franchise relationships. 

So while the number of private dispensing optometrists grew, the number of optometrists 

affiliated with optical retailers grew even faster. And so by 2012, there were 40,000 optometrist's 

in active practice. And 57% were independent. And independent-- I again go back to my 

semantic definition-- they were not in affiliation with an optical chain, but rather, selling at the 

location where they prescribed, also selling eyewear. 

And in 2012, optometrists were up to doing 88 million refractive eye exams, not eye health only. 

And that was out of 104 million. So the percentage of eye exams by optometrists compared to 

that refractive exam or even primary eye care eye exams by opthamologists continued to drop. 
Chain affiliated doctors, doctors who prescribed near a brand optical retailer, has multiple 

formats. I thought it would be useful for the FTC and this audience to understand what some of 

those might be. And again, I hope this is a reasonably complete picture, but I welcome feedback, 

and the FTC is, as I said, taking comments till April 6. 

But the most typical is the independent contractor, where an optometrist who owns his or her 

own practice will practice in co-location with an optical retailer, usually through a sublease or a 

license agreement. The office is typically equipped by the landlord or the licensor. And most of 

those agreements sublease or license would specify that the prescriber won't sell eyewear, doesn't 

profit from the sale of eyewear, and in fact, may face restrictions like Medicare fraud and abuse 

in being involved in profiting in any way from the sale of that eyewear. 

And as I said, it's the most frequently used . Format covers probably 80% of the locations that I 

mentioned earlier. And often, a sublease or licensee will employ other optometrists and staff to 

help operate the practice. They may have multiple locations, and as a result, it's a little hard to 

say that all of these are employers versus employees. I think the number of optometrists who are 

employed by someone else, whether it's an optometrist or an ophthalmologist, an HMO or the 

VA, continues to grow. That being an employee as an optometrist seems to be an expanding part 

of that profession. 

Not very many optometrists are directly employed by optical retailers. Maybe 5% to 10% based 

on my observation. Most states prohibit the corporate practice of optometry. And it depends on 

the volume and structure of the location, but it's not always an easy model to maintain. So even 

when optical retailers could legally employ, they often choose not to do so. 

And then finally, there are also franchises. And I'm talking now about the optical retail 

community that we talked about earlier, where the owner could be either a prescriber, or an 

optician, or retailer, but that's only 5% to 10%. Pearle Vision, for example, is a fairly large 

franchiser. There other optical retail chains that franchise their business as well. 

I am not including in this, as I mentioned earlier, the Vision Source Group, which I think has 

maybe 3,500 locations, and 5,000 doctors involved. And that is a franchise relationship, but the 

doctor still has a significantly different kind of relationship with the franchiser. And so it's not 

included in the optical chain numbers. 

Who's doing the prescription of contact lenses? From the data that I saw in 2013, the 

optometrists were doing 85% of the comprehensive eye exams, and wrote 90% of the 

prescriptions for corrective eyewear. And 27% of those exams were contact lens exams. I think 

that the data that was most recently reviewed suggested that the independent eyecare 

professionals, which would include ophthalmologists-- and I used OMD as the shorthand for 

ophthalmologist here but I think maybe 5% to 10% of ophthalmologists are osteopaths, not 

medical doctors, but it's really irrelevant to the scope of practice. 

The ODs affiliated with optical retailers did about 28% of the contact lens exams. Maybe it's not 

surprising, but nearly 9% of contact lens wearers reported they didn't know or got their eye exam 
someplace else. And that suggests to me that ophthalmologists are writing under 10% of the 

contact lens exams. 

Steve made the comment that independent doctors sold 37% of lenses, the private ODs. And 

when you look at how much the chains and the online retailers sold, ophthalmologists are not 

selling a lot of the product. Perhaps under 4%. I will comment that I don't know that optometrists 

are losing 100% of the supply of contact lenses that their patients wear. 

I think it's fairly typical for the initial exam fitting and evaluation to include the sale of some 

product, and then the first 30, 60, or 90 days, would go out with the patient, with the prescription. 

And then the growth in the mass merchants, and clubs, and online sales are more of the 

replenishments sales. So it's a little hard to tell. But if people are only buying $50 at a time or 

$52 at a time, that would suggest that they're making more purchases during the year. And Steve 

may be able to explain that in more detail later. 

So product modality. I guess that's the other thing Steve's already flagged for you, but there's a 

lot of shift going on, both in dollars and patients, as one day wear has been the shining star in 

growing and continuing to grow. Two week is declining, and people are either going monthly or 

to the daily wear. And it looks like the specialty lenses and gas perms have been fairly stable. I 

was a little surprised to see that patient share for gas perms and specialty lenses was higher than 

their dollar share, but that would suggest that some of these other lenses are just more expensive, 

I would think. 

And vision care insurance-- Steve also flagged this for you-- but the numbers that the division 

counsel describe about the number of people, the 50 some odd percent of people that make a 

purchase involving their benefits include a lot of alternatives to pure insurance. It could include a 

vision plan that's a standalone plan. It could include a health benefit, but it also includes 

government plans, and FSAs, HSAs, and other spending accounts. And even discount plans, 

although that's not a significant percentage of the 51% that he mentioned. And surprisingly, 

there's a lot of people that don't know. 

But maybe that shouldn't surprise. 

The employers do often vision benefits as an option, and it's growing. For those of you who are 

not familiar with vision care insurance, monthly benefits for an individual depending on the plan 

could cost $10 to $20 a month. And as Steve mentioned, about half have vision care coverage. 

Children have it. 

Apparently though, that's not well known by parents. To their credit, the vision counsel has spent 

time and money trying to figure out how many are using vision benefits and what they know, and 

how often they're getting eye exams. Since the Affordable Care Act made pediatric vision care 

an essential health benefit, there's been some data, but it appears from the division counsel 

studies that a lot of still aren't aware that they even have coverage. And as a result, the Vision 

Counsel is doing this a couple of times a year-- Steve, is that right? 
Every other year, sorry. I wasn't sure if a semi or bi, but every two years, because it's so 

expensive to find who can remember and talk about what they're under 18-year-old child did 

with respect to the eye exam. So there's some data out there but it's not nearly as robust as the 

other data from the consumer panels, because of the difficulty in surveying parents. 

But as Steve mentioned, 50% of contact lens buyers do report that they had some benefit. And it 

might have been a paid benefit, or it might have been a discount, but that's a lot less than in the 

eyeglass buyer side. The other thing that's interesting is that it's usually an either/or kind of 

benefit if you're using IMED or VSP. You get $1 allowance for frame and lens, or for contact 

lens fitting evaluation, and contact lens product. And it could be $100, $150 once a year. And I 

think it's possible also that the wearers out there-- this is speculation on my part-- eyeglass 

wearer will alternate, and get contact lenses one year, and eyeglasses the next. But they try to 

make sure they're using their benefit. 

And of course, there could be discounts from a plan that apply to the product purchase beyond 

what's the covered benefit. That doesn't exist in all plans, and may be restricted in some states, 

but it would be typical to see a 20% discount on additional product. 

And then a couple of slides just to show you the variety in contact lens price. And this is what I 

have to caveat-- I got a couple of industry sources-- this seems directionally corrected. If people 

want to go out and shop for contact lenses, they're going to be able to find a real range of prices. 

And independent ODs, depending on whether you're getting rebates, what's included, whether 

you're buying an annual supply-- it depends on the product-- but the internet channel, and 

national retail channel, and club channel will vary depending on the product. 

And it also-- I just went to double check this-- but it varies by the day. What's the day rebate. 

What's the special going on. Are you a first time buyer on that particular channel, you can get an 

additional rebate. So there are a lot of ways to price shop, but it can be pretty complicated. And 

you also have to consider, as the buyer, what bundle of services you're buying. What are your 

return rights, or follow up, and other care included. Are there any warranties, et cetera. 

And it's also in daily's-- the similar kind of thing you'll see-- a range of prices subject to some 

rebates. And even within a channel, you might find significantly different prices, say between 

one national retailer and another. So the numbers that I've put up here for the FTC to look at are 

really averages, and it doesn't indicate that every national retailer or every club sale is selling at 

exactly that price. And my guess is if we went and looked, it would all be different today. But 

there are certainly a lot of ways that you can look for price on the internet. So that's it. Thank 

you. 

BETH FREEBORN: Thank you, Steve and Wally. And next, we have Rich Cleland and Andrew 

Stivers, moderating our panel on contact lens health and safety. 

RICH CLELAND: We're in good shape. 

Good morning. 
Contact lenses are regulated medical devices. And it is widely recognized that contact lenses 

involve some safety risks. And the goal of this panel is to examine some of those risks as they 

relate to the content lens rule. Before getting into that, I would like to briefly introduce our panel 

members. And there is additional information in the program material for the bio, so I'm not 

going to give you everything here. 

My name is Richard Cleland. I'm Assistant Director of the Division of Advertising Practices at 

the Federal Trade Commission. My co-moderator is Andrew Stivers, who is Deputy Director of 

Consumer Protection in the Bureau of Economics at the FTC. Andrew oversees the provision of 

economic analysis, and advises to the Commission on all consumer protection matters. Andrew 

Joined the commission in 2014 after serving as Director of the Consumer Public Health and 

Statistical Analysis research division at the US Food and Drug Administration Food Center. 

Our next panelist is Dr. Jennifer Cope. Is a medical epidemiologist-- and there's going to be more 

of those, folks. My tongue doesn't always do what my brain says it should. Disease Physician at 

the Waterborne Disease Prevention branch in the National Center for Emerging and Zoonotic 

Diseases. She oversees the CDC'S health program, and has published several articles on contact 

lens wear, behaviors and risk factors associated with infections. 

We are also joined by Dr. Malvina Eydelman. And she is a board certified ophthalmologist for 

over 20 years as an expert medical officer, Senior Medical Advisor, Director at the FDA's 

division of Opthalmic, Neurological, and Ear, Nose and Throat Devices and Director of the 

FDA's division of Orthonomic and Ear, Nose and Throat Devices. Dr. Eydelman has played a 

key role in assuring the safety and effectiveness of medical devices. 

Dr. Michelle Tarver is a medical officer of the Food and Drug Administration, and the Center for 

Disease and Radiological Health. She joined the Food and Drug Administration in 2009, where 

she works on ensuring that contact lens devices are safe and effective before entering the US 

marketplace, as well as conducts research that incorporates the patient's voice in the evaluation 

of such devices. 

Also joining us is Dr. Carol Lakkis, who is currently the clinical research fellow at the head of 

Applied Clinical Services at Johnson and Johnson Vision. She has over 100 publications, has 

lectured extensively, and is recognized as an international expert in ocular microbiology, and 

contact lens related infection and inflammation. 

Finally, Doctor Edward Chaum is the University of Tennessee Hamilton Eye Institute Inaugural 

Plough Foundation Professor of Retinal Diseases and Professor of Pediatrics, Anatomy, and 

Neurobiology, and Biomedical Engineering. Dr. Chaum will become the Margy Ann and J. 

Donald M. Gass Professor of Ophthamology at the Vanderbilt Eyecare Institute in April of 2018. 

With that, I'd like to turn the program over to Dr. Jennifer Cope from the CDC. Thank you. 

JENNIFER COPE: OK thank you I just want to check can I be heard 

Yes? 
Great. 

So I just want to say thank you to the planners for this invitation to speak here today, and for this 

opportunity to present a public health perspective to this issue of contact lens health and safety. 

First off, I'll just spend a minute or two-- I often start a lot of my presentations this way-- as to 

why someone here works in the waterborne disease prevention branch at CDC works on contact 

lens health. 

Next slide, please. 

So this goes back to our expertise on organisms called free living amoeba, of which one of them 

is acanthamoeba. And acanthamoeba is the cause of acanthamoeba keratitis, or AK, which is a 

serious-- fortunately, rare-- but serious cause of keratitis most often associated with contact lens 

wear. And so it was our expertise in this disease that started our work in contact lens health. And 

it really goes back to the mid '80s, when our group was called upon to offer advice on increasing 

numbers of case reports of acanthamoeba keratitis. And that led to our first case control study, 

looking into risk factors for this condition. 

Next slide. 

Fast forward about two decades and that brings us to around 2006, when again, we found 

ourselves in the same position receiving increasing numbers of reports of acanthamoeba keratitis. 

And this led to another case control study , a large multi-state investigation. And it was during 

this investigation that a specific multi-purpose solution was identified as the primary risk factor. 

And this resulted in the recall of the solution. 

However, we also documented a lot of other types of behaviors that were putting people at risk 

for contact lens related infections. And even after this recall, we noted that these infections did 

not go down to the previous levels. And so that led to subsequent a case control study conducted 

in 2011, during which we did not find an association with a specific solution, but again, 

documented a lot of behaviors that might be putting wearers at risk. 

And so it was at this point where the group I work with that CDC decided, well, we enjoy 

investigating disease outbreaks. We wanted to put into practice what we had learned, which was 

there are a lot of behaviors going on, and probably a lack of awareness as to what these 

behaviors could be doing to contact lens wearers. And so we really took to heart that second part 

of CDC's, name which is the Centers for Disease Control and Prevention, and really started to 

develop our healthy contact lens programs to start to try to prevent these infections, rather than 

continue investigating outbreaks. 

So next slide. 

So our healthy contact lens program has a health promotion and education aspect to it, which I'll 

get into a little bit later. But another aspect of it is just answering some basic questions that we 

had as a result of the work we had done. One of those questions was, how much keratitis is there. 
And while this seems like a straightforward question, there wasn't a straightforward source of 

data to answer this question. 

A lot of the diseases we investigate here at CDC are what we consider nationally notifiable or 

reportable conditions that have to be reported to a state or local health department. Keratitis is 

not one of those. And so we have to be a little bit creative in how we try to answer this question. 

So we ended up using data from the National Ambulatory Care Emergency Department and 

insurance claims databases. In using this approach, we estimated that there are 930,000 doctor's 

office and outpatient clinic visits, and 58,000 emergency department visits annually for keratitis 

and contact lens disorders. And we are also able to estimate that these costs approximately $175 

million in direct health care expenditures on an annual basis. 

So next slide. 

Another basic question we wanted to answer was what epidemiologists are always searching for, 

which is our denominator. So how many people are at risk for this condition. And so in this case, 

this is contact lens wearers. And so one basic question we wanted to answer was, how many 

contact lens wearers are there in the United States? We know there was a lot of market research 

data on that, but we wanted to put an estimate out in the scientific literature. 

And then the second part of that is what are these contact lens wearers doing. What are their 

behaviors, how prevalent are these behaviors. So that led to our estimate of 41 million adult 

contact lens wearers. And then the second part of that was surveying about 1,100 wearers, in 

which we determined about 99%, or almost all of them reported at least one contact lens hygiene 

risk behavior. And also, part of that survey, nearly one third of them reported having experienced 

a contact lens related red or painful eye that required them to seek medical attention. 

Next slide. 

So diving in a little bit deeper to that survey of the 1,100 contact lens wearers, this table is 

showing the most frequently reported behaviors. So the most frequent reported behavior that 

could put them at risk was napping in contact lenses. 87% reported that, as well as about half 

reported sleeping overnight in them. And I point that out because other work in the literature 

does show that sleeping and napping in contact lenses to be one of the riskiest things that you can 

you to put yourself at risk for contact lens related infection. 

Another common behavior was topping off solutions. So this is when you don't completely dump 

out the old solution in your case, and you just top it off with some new solution. This was done 

by over half of the respondents as well. About half reported on replacing their lenses in an 

interval longer than what was recommended. And then also, a very large percentage reported 

replacing their case at an interval longer than recommended. 

Next slide. 

I know there's been data already presented on this, but as part of this survey, we also asked 

where the wearers were purchasing their lenses. Based on this 2014 data, the majority were 
purchasing them in a provider office. 10% we're purchasing them in a retail store without the eye 

them. And then nearly 21% we're purchasing on the internet. 

Next. Slide 

And then we did ask this question again in 2016, when we also included adolescents as part of 

the survey. Numbers don't look terribly different than the 2014 numbers. Again, most are 

purchasing in the provider office. And then for the internet purchase, you notice that the young 

adult age group, the 18 to 24-year-old age group, is the one purchasing from the internet most 

frequently. 

Next slide. 

So some additional work we did in collaboration with our FDA colleagues was to use a different 

data source to kind of, again, get at some of these questions we had about how much keratitis, 

and what types of the behaviors do our wearers have. This time we again collaborated with FDA 

to use their medical device report database. As you'll probably hear more about from my FDA 

colleagues, contact lenses are regulated medical devices, and as such, manufacturers are 

mandated to report any adverse events occurring with those devices. 

So in this study, we found just over 1,000 contact lens related medical device reports that 

contained the term ulcer or keratitis. And not surprisingly, most of them came from 

manufacturers, and a smaller percentage were reported by the eye care provider or the patient. 

And 20% of those described a patient who had essential corneal scar, a decrease in visual acuity, 

or required a corneal transplant following the event. And we reported this data to show just how 

serious, some of the outcomes are for these events. 

Next slide. 

As I mentioned, the other aspect over healthy program is a health promotion and education 

aspect. What we were finding is that just a lot of contact lens wearers were not even aware that 

some of these things they are doing that they probably just considered harmless shortcuts could 

actually be putting them at risk for a contact lens complication. 

And so on this slide, we just have a couple examples of some graphics that we've created that can 

be used on social media. You'll see on the far right, we have our contact lenses are like 

underwear campaign that's been very popular, and has gotten a lot of attention. 

Next slide. 

One of the hallmarks of our healthy contact lens program is contact lens health week, which has 

been marked every August, and will be coming up this August for the fifth annual contact lens 

health week. And that's kind of our major push to get a lot of these messages out through social 

media, and through our partners. And this is usually the research that I just presented on 

estimating the burden of keratitis, and reporting on these behaviors. We publish in our CDC's 
publication morbidity and mortality weekly report. And so we usually kick off the contact lens 

health week by putting out whatever our report is that year to garner more attention. 

And then next slide. 

I'm not sure if we'll be able to get this to work, but this is a video series that we completed last 

year that featured three patients who had an infection related to their contact lens wear. And they 

are like video testimonials in which they describe what happened, and kind of the lessons learned 

from that. So if we can get it a play, it's about two and a half minutes. Great. 

[VIDEO PLAYBACK] 

RON PARIS: My name is Ron Paris. I'm from Madison, Alabama. I'm a junior at the University 

of Alabama. 

I first noticed that my left eye had a problem when we were about to play LSU, and I was getting 

ready for game day. And I looked at my roommate, and I said hey, is there something wrong 

with my eye? He said, no, it looks fine, looks fine. But I was having a lot of pain. And after that, 

my eye started getting more and more shut every day. And I started feeling more and more pain. 

You know, I just thought it was another scratch, but I didn't know what it was going to turn into. 

About a month later, I went to a doctor's office in Birmingham, and she was like, you have 

acanthamoeba keratitis. I was like, OK, what is that? She told me that some people experience 

blindness, very sensitive to light. And that basically, it eats away at your cornea to the part where 

you can either just go completely blind or you have to have a cornea transplant, or you would 

lose your eye. And so of course, I'm like, OK, well all those sound bad. I'd rather not have to do 

that. 

I was a terrible contact lens user when I was in elementary school. And I got better when I got to 

middle school, but it still wasn't very good. So I'd just wash them out in tap water, or lake water, 

or river water, wherever I was. That was just a normal thing for me. I saw my grandfather had 

hard contacts, and I saw him do that all the time. So I'm like, all right, no big deal. So it was just 

another thing. I didn't figure anything could come bad from it. It's just water. 

Tap water definitely contributed mostly to the whole thing. That week, I ran out of solution, so I 

just was using tap water. Just a normal thing for me. Right now, I have a giant scar on the middle 

of my left eye from infection. I cannot see directly in front of me. I can see peripherals pretty 

good, but I cannot see directly in front of me very well. If I covered up my right eye right now, I 

could kind of tell what was going on around me, but I couldn't really say specifically who 

someone is. 

We're hoping that surgery or whatever goes well to get that scar away from me, so I can go back 

to seeing normal and maybe even wearing contacts again. 

If I knew more about washing contacts and what then, I feel like this would have been 100% 

avoidable. 
[END VIDEO PLAYBACK] 

JENNIFER COPE: Well, thank you. That's all I have. 

RICH CLELAND: Turn it over to you Dr. Eydelman, please. 

MALVINA EYDELMAN: It's OK. 

Good morning, and thank you for the invitation. As you heard, I work for the Food and Drug 

Administration. And I would like to take a few minutes to share with you what we do at the FDA 

to assure US regulation for safe use of contact lenses. 

I would like to start out by acknowledging the staff members on this slide who have put together 

this presentation. Most of them are here in the audience, and hopefully, will be available 

throughout the meeting should any of you have questions. 

This as the official definition of a medical device. Medical device is intended to diagnose, cure, 

or mitigate, treat, or prevent a disease or condition, or intended to affect the structure or function 

of the body, and does not achieve intended use through chemical action on metabolism. I would 

like to point out that unlike drugs, there are no generic medical devices. 

All of the devices are classified into three classes. Class 1 being the simple design, the lowest 

risk. And most of these are exempt from pre-market submissions. Class 2 are more complex with 

moderate risk. And most of these require pre-market notification to demonstrate substantial 

equivalence before they are allowed to be marketed. Class 3 are the most complex, highest risk, 

and these require PMA or pre-market approval to demonstrate reasonable assurance of safety and 

effectiveness before these devices reach the US market. 

FDA regulates all contact lenses. Lenses are classified as either class 2 or class 3. All daily wear 

lenses, soft, and rigid, gas permeable are class 2. And all of the extended wear lenses are class 3. 

I would like to emphasize the point that in addition to the refractive error corrections, there are 

contact lenses that cleared or approved for other indications, specifically to promote corneal 

healing, bandage contact lenses. For the temporary reduction of myopia, or orso-k. To enhance 

or alter the appearance of the eye, decorative contact lenses. 

Again, these are indications which are currently available in the US. But I would like to 

emphasize that currently, we are seeing an explosion of other indications that they are being 

studied, and developed by the manufacturers in the US. 

Per our colleagues from CDC, there are approximately 45 million Americans who are wearing 

contact lenses. 35% wear daily disposable. Over 90% of adult contact wearers use soft contact 

lenses. Now the next two bullets weren't emphasized sufficiently so far. So I'd like to bring to 

everybody's attention that about 11 million wearers are between ages 12 and 24. Thus, teens and 

young adults-- there's a significant public health impact in that population from contact lenses. 
The risks from the use of contact lenses are many, and have been addressed by a number of 

speakers. Some of these, not all, are listed on the slide. These include microbial keratitis, 

allergies affecting the eye, GPC, corneal abrasion, contact lens induced acute red eye, corneal 

infiltrates, dry eye, and neovascularization. 

In a study that looked at all of the emergency room medical records reports from the National 

Electronic Injury Surveillance Database, it was found that contact lenses accounted for most 

medical device adverse events compared to all other devices. I bring this fact to emphasize the 

impact of public health that contact lenses have. Subsequently, FDA has worked very diligently 

to put a number of safeguards to assure the safety of contact lenses. 

We spend significant resources reviewing pre-market submissions. My division has been 

involved in standards, both on the national and international level for a number of decades. We 

have guidance, post-market surveillance, such as MedWatch, PAS, and 522 studies. We have 

conducted our own research. And we have spent a significant amount of resources on outreach. 

All contact lens pre-market submissions undergo thorough review by the team in my division. 

We make sure that we review the materials and chemistry, manufacturing, sterility, shelf life, 

biocompatibility, performance testing, non-clinical, and clinical performance testing. 

Recommendations for these are described in our guidance and the recognized standards. 

The chemistry review of contact lenses is quite unique. Properties unique to each contact lens 

product that may affect performance are summarized on the slide. These are material 

composition, physical properties, surface characteristics, packaging solution composition, 

material and manufacturing residuals, interaction with care product solutions, and lens design. 

Evidence supports marketing clearance or approval for each new lens material that reaches the 

US market. We assess the following-- adverse reactions, slit-lamp exams, symptoms, problems, 

complaints, keratometry changes, visual acuity, average wear times, discontinued lens 

replacement, contact lens performance, and lens surface characteristics. 

We communicate many of these in our contact lens labeling. The following couple of slides 

summarize the information in our contact lens labeling that is similar to the prescription 

elements. Specifically, manufacturer's brand name. This really refers to the entire device, 

inclusive of the material name, manufacturing process, packaging solution, and other factors 

which may impact the unique attributes to the lens material. Distinguishing attributes can result 

in differences among materials in contact lens fitting, performance, and ultimately, in ocular 

health. 

Base curve affect the alignment of the lens to the topography of the central cornea. Important to 

point out that same base curves for different brands may not be clinically equivalent. Diameter 

affects the lens centration. And once again, same diameter for different brands may not be 

clinically equivalent. Dioptic power affects strength of the correction. Improper power may 

result in reduced visual acuity, eyestrain, and headaches. 
Currently, there is no regulatory pathway for marketing of generic contact lenses. The current 

clinical care paradigm does not support substitution of contact lens brands without clinical 

evaluation. Additional research in education is needed regarding critical design and material 

properties to support clinical equivalency between brands. 

As I mentioned, we at the FDA have worked for a number of decades in creating and recognizing 

consensus standards. This slide is a summary of those standards, which have been recognized by 

the FDA. These include both US and international. 

Additionally, we have two current FDA guidances which describe our interpretation of a policy 

over regulatory issues, and they talk about labeling, manufacturing, and clinical studies that we 

would like to see in the submissions. 

Post-market, we have a number of ways to collect information to report adverse events, including 

related infections. The slide contains the link to the FDA MedWatch and the FDA website 

specific to report the problem with contact lenses. Additionally, when needed, we have 

conducted 522 studies, which has a mandated post-market surveillance study. 

Given the impact on the US Public Health, we have taken unprecedented measures and 

conducted quite extensive research in-house. As a result of our research over the last 10 years, 

we have categorized the numerous silicon hydrogel lenses to address concerns was dimensional 

stability and toxicity. We evaluated the efficacy of care product solutions in the presence of 

lenses i.e. real world evidence, real world testing. And we developed acanthamoeba test 

methodology. The references on the slide summarize some of our articles. Most of these in the 

ion contact lenses, and the last one was published just a couple of weeks ago. 

To ensure the safety and the transparency of our work, we have held a number of public 

meetings over the last decade. Most of these are summarized on the slide. As you can see, we 

have had advisory panel meetings and a workshop to address different aspects of safety of 

contact lenses. 

We have a separate team dedicated to outreach for contact lenses. We have published consumer 

focused articles, which were distributed to over 75,000 subscribers. We have very popular 

websites, two of which are dedicated to contact lenses at FDA. One is to all contact lenses, and 

one to decorative contact lenses. We're very fortunate to partner with CDC and working on their 

website as well. 

We have conducted Medscape commentaries and interviews. Have put together and a number of 

videos, including public service videos, which inform the proper way to wear lenses, and 

recommended getting an eye exam and a valid prescription. 

And we have done something very unique for FDA. We have launched a Twitter campaign 

regarding decorative contact lenses. And as my CDC colleague has mentioned, we also 

participate in the contact lens health week, and have launched a Google AdWords campaign. 
As you can see, we take safety very seriously, and have dedicated a significant number of 

resources to assure that the Americans who wear contact lenses remain healthy. Should you have 

any further questions, I suggest you contact Dr. Angelo Green, who is in the audience. Angelo, if 

you can wave, he's the acting branch chief overseeing contact lenses at the FDA. Thank you very 

much. 

RICH CLELAND: Thank you. Dr. Lakkis, go ahead. 

CAROL LAKKIS: Good morning, everyone. My name is Dr. Carol Lakkis, and I'm representing 

Johnson and Johnson Vision Care Incorporated. As the head of applied clinical sciences within 

the contact lens research and development group, I'm responsible for leading exploratory 

research to support new product development. 

In my role at Johnson and Johnson Vision, I bring decades of experience as both an ocular 

microbiologist, and optometrist, and have spent more than 20 years conducting research on 

contact lens related infection and inflammation, disinfection and discomfort, and the therapeutic 

management of ocular disease. In short, I've dedicated my career and my work at Johnson and 

Johnson Vision to improving patients' overall eye health and the contact lens wearing 

experience. 

Today, I'm pleased to be here to offer my perspective on why it's vital that our vision care 

regulatory framework continues to preserve the eye doctor-patient relationship to achieve two 

important goals. First and foremost, to minimize health related risks and complications 

associated with contact lens wear. And secondly, to bring new and innovative contact lens 

technologies for physicians and patients. 

Over the past three decades, as the contact lens landscape has grown, eye doctors continue to 

play a critical role, not only in promoting eye health, but also in working with individual patients 

to find the most appropriate contact lenses to meet their unique and evolving needs. 

Ensuring patient access to an eye doctor for a contact lens fitting and evaluation is critical, 

because contact lenses are applied directly onto the ocular surface, and these complex lens 

materials interact with the environment, including the patient's cornea, tear film, and eyelids. In 

clinical practice, I would regularly explain to my patients that finding the appropriate lenses for 

their eyes doesn't just provide them with overall comfort and enhance their lens wearing 

experience, but more importantly, it can minimize the negative impact on their eye health, not 

just over the next year, but over the next 50 years. 

That's why wearing any type of contact lens not prescribed by an eye doctor could lead to a 

variety of complications from mild discomfort to severe adverse events like inflammation and 

infection. Current research suggests that inflammation and infection are on a continuous 

spectrum. 

So while an issue like inflammation may not sound like a critical health condition, it's important 

to address as quickly as possible so that it doesn't develop into something more serious, or cause 

any permanent damage to the eye. In fact, because clinical complications can arise prior to the 
onset of symptoms, a regular comprehensive exam with an eye doctor is critical to minimizing 

risks and impacts on eye health, and reducing unnecessary costs to our health care system. 

While we know the value of regular patient visits to their eye doctor, one of the most significant 

challenges that we face stems from the fact that contact lenses have become widely used, and as 

technology has evolved, doctors and scientists like myself have focused on ways to minimize 

risks associated with wearing lenses. And we've had great success. 

However, these successes also make it easy to underestimate the importance of consistently 

going to the doctor for a comprehensive eye exam, even when a patient's current contact lens 

seem to be working, and their eyes seem to be healthy enough to continue to wear their lenses. 

Furthermore, a patient's eyes are a window to their overall health, and need ongoing care to keep 

avoidable health risks low. 

Importantly, the challenge of reducing contact lens adverse events isn't unique to the US. We 

have some notable advantages in how our current regulatory system balances access and choice 

with patient eye health and safety. In fact, when looking at adverse events globally, the research 

suggests there are higher risks in markets where patients don't need prescriptions for contact 

lenses or in those markets that don't require a comprehensive eye exam with an eye care 

professional. 

For example, in many Asian countries, patients don't need prescriptions for contact lenses, and as 

a result, higher infection rates are reported. In addition, contact lenses can be the leading cause of 

corneal infections in unregulated markets, such as in Taiwan, which is not always the case in 

studies from regulated markets such as the US and Australia, where ocular surface trauma and 

diseases are common causes of infection. 

It's extremely important to balance source of supply with an eye doctor's guidance and 

supervision to make sure lenses have fitted correctly, and maintain biocompatibility with the 

patient's eyes. 

So in closing, at Johnson and Johnson Vision, we take our role as a leader in eye health 

seriously. It provides us with a platform to advocate for better standards of care for all patients. 

As part of this commitment, we support the eye doctor-patient relationship, and continued patient 

access to innovative lenses, which best addressed that evolving eye health needs. 

I'd like to thank the commission for this opportunity to share my comments here today. And I'm 

happy to address any questions during the panel discussion. Thank you. 

RICH CLELAND: Thank you. Dr. Chaum. 

EDWARD CHAUM: Thank you. I'd like to bring just a slightly different perspective to the 

conversation this morning. I think you've heard some really important data about the potential 

risks of contact lens wear if they're not managed properly, and proper hygiene isn't used in their 

daily care. I think it's very clear, and I certainly agree that all patients who wear contact lenses 
should have an appropriate fitting by an eye care professional. I don't think there's any there's any

question about that. 

But a lot of the health issues around the availability of contact lenses for consumers has focused 

on the need for an annual eye exam that, in some way, it's critical, as Dr. Lakkis says, feels it's

critical for there to be an annual eye examination for the patient, for the patient's health. And the 

America Optometric Association has a preferred practice pattern, and they recommend an annual 

eye examination. And I certainly respect the perspective of that Academy. And obviously, its 

members are going to follow the recommendations of their professional association. 

I'm an ophthalmologist, a physician, and surgeon. And my professional academy, the American 

Academy of Ophthamology has a different recommendation. And I think it's important for the 

FTC and consumers to understand that there's a difference of opinion about what is required to 

maintain proper eye health. 

So my academy issues what's called a preferred practice pattern. It's their recommendations of 

how we should manage patients. And the Academy's preferred practice pattern for patients 

between the ages of 18 and 40 is that those patients need a periodic eye examination to maintain 

good health. And that examination should occur anywhere between five and 10 years. That's the 

recommendation of AAO, not mine. That's the recommendation of the AAO. 

Patients under the age of 40 should have a good complete examination every five to 10 years. 

Patients above the age of 40 and less than 55 should have an examination every two to four 

years. So I think there's a legitimate difference of opinion between the professional societies as 

to what is required in terms of a periodic exam to maintain good health. 

Now clearly, the risk of developing conditions like keratitis in contact lens wearers is known. Dr. 

Cope has presented a good example of that. It's not an infrequent occurrence. You've seen the 

numbers there. But Dr. Cope's data also shows that the vast majority of those patients are cured 

within one visit of the physician. She's published that data. 

And it's not clear, actually, that seeing a physician or an optometrist on an annual basis has any 

impact at all on the incidence or prevalence of keratitis. There's actually no data in the published 

peer reviewed literature that shows any beneficial relationship between a normal eye 

examination and the incidence of keratitis. 

As a matter of fact, there's one page paper in the literature that actually addresses that 

association. It was published by Morgan in 2006. And it showed that for case controlled patients 

who had an episode of keratitis, the patients who had documented a normal healthy eye exam 

within six months of developing that keratitis were at a two-fold increased risk of developing 

keratitis. In other words, the normal eye examination documentation was associated with a 

higher risk in that case control study. 

So there's something about the exam per se, that puts that patient at risk. Maybe that patient's 

behavior changed. But it's clear from the publications across the world for the last 25 years that 

the risk factors associated with the development of keratitis and contact lens wear are behavioral 
and hygiene related risk factors. It is sleeping in your lenses. It is napping in your lenses. It's not

changing the solutions. 

And we've seen this dramatic decrease in the incidence of keratitis over the last few years that 

you've heard about in parallel with the onset of the adoption of daily wear lenses. And it's that 

change in technology that's making contact lens wear safer for patients and reducing the risk of 

keratitis. 

And so really, in terms of sort of helping the FTC decide how should patients get their lenses, 

who should provide them, the data clearly shows that open access through channels of large 

retailers online really has no impact at all on the incidence of keratitis, and complications. It's all 

about the patient's behavior. 

And again, Dr. Cope showed some data earlier this morning that show that the incidence of 

keratitis in patients was unchanged. Two thirds of those patients had a close relationship with 

their prescriber, and had gotten their lenses from their prescriber. And one third of them had 

gotten them online. There is no relationship between documenting a normal exam in an 

asymptomatic patient and the risk of keratitis. 

So I don't think there's any question that we all want to provide good health care. The question is 

how do we provide that in a way that is convenient for the patient, that meets their personal 

needs, and meets their financial needs, that addresses appropriate management of health care 

risk, and provides an open forum for patients to participate. And for the physicians to help them 

wear their contact lenses safely. Thank you. 

RICH CLELAND: Thank you. 

I would like to start up actually kicking off a couple of things that you said, Dr. Eydelman, and 

talk a little bit first about the interchangeability of lenses, and the characteristic of lenses that 

suggest that they may not be interchangeable. And you had a couple of slides here in your 

presentation about what's unique about contact lenses as well as some labeling-- a slide relating 

to labeling-- where you mentioned base curve diameter and dioptic power. I wonder if you could 

comment on what the relationship is between these elements, and the risk to the eye. 

The material may be different. How does that relate to safety? 

MALVINA EYDELMAN: And I was hoping-- I don't know if there's a way to project the slides 

back, but I was trying to go back and highlight the specific aspects of prescriptions. 

No, I have it. Just the notes so the audience can see it again. Basically, my groups spent a bit of 

time to try to be very objective, and clearly stated what are factual. 

First of all, what we put in the labeling-- only factual information, as you can imagine. We spend 

a lot of time reviewing the submissions, and then communicate that information in the labeling. 

And the point we wanted to make-- and I'm going to just essentially accentuate the same-- that 

the manufacturer's brand name refers to the entire device. And distinguishing attributes within 
that manufacturer's brand name can result in differences among materials and contact lens fitting, 

which will have impact on performance and ocular health. 

RICH CLELAND: Right. And I'm trying to distinguish between what part of that relates to 

comfort, and what part of that relates to safety. 

MALVINA EYDELMAN: So sometimes, comfort has to do with fitting. And if it doesn't fit 

right, first you're uncomfortable. And then at some point, you start getting irritation and 

subsequent inflammation. And I would like Dr. Tarver to pipe in. 

MICHELLE TARVER: So the factors that Eydelman already described in her slide about the 

different materials-- there are other aspects, such as the stiffness of the material, how the lens's 

edge, and how it interacts with the ocular surface that potentially could put the patient at a higher 

risk of infections. And so some of those factors are not the same, even though it may be the same 

material, or the same base curve, or the same diameter. They may not fit exactly the same from 

patient to patient, or within the same patient. 

RICH CLELAND: And there is no way to determine that without an actual fitting? I mean, we 

got 41 million contact lens wearers. Obviously, some of those could wear any type of lens, or 

most types of lenses that are popular. 

MALVINA EYDELMAN: And so unfortunately, at the current time, the same diameter of 

different brands is not identical. The same base curve, the same number, if it's a different brand, 

doesn't mean the same thing. So ultimately, you still need to fit in or the prescribe the appropriate 

contact lens. 

EDWARD CHAUM: There may be a movement towards a more generic fit. There was a 

publication in Contact Lens Spectrum last year by Engel that showed that if you look at lenses 

that are available by brands, they're really becoming commodities. There's one diameter for most 

brands, and one or two base curves. And Engel's paper showed that 90% of patients had a good 

and comfortable fit with just selecting one of those base curves, and 98% of those patients were 

comfortably fit if you checked both. 

So the changes in the way the lenses are made, the thinness, the nature of the wear with the 

lenses is becoming, at least according to this author, much less dependent upon the specific fit, 

and much more of a generic type of fit. 

CAROL LAKKIS: I was just going to add that while there are many different features to lenses 

that can impact the way that they fit, what we do know and from the research data is that if, for 

example, a lens is tightly fitting on the eye, then the risk of having an inflammatory or infectious 

event increases. And sometimes, those things can't be detected just at the fitting visit. It requires 

evaluation after the lens has been worn for some time, and that is necessary during follow up 

visits, and examinations at different times of the day. So there are specific ways that different 

properties of the lenses can actually impact fit that have a distinct impact on comfort comfort, 

but also on actual eye health. 
MALVINA EYDELMAN: To come back to your point, [INAUDIBLE] would be wonderful if 

one day the base curve would mean exactly the same thing for all brands. Unfortunately, we're 

not there today. 

RICH CLELAND: I have one more follow up question on this topic, and then we'll move on. But 

in your slide presentation, you had the statement that additional research in education is needed 

regarding critical design and material properties to support clinical equivalency between lens 

brands. Given the current regulatory and market structure, is there actually incentive out there to 

conduct that type of research? 

MALVINA EYDELMAN: So maybe this workshop will be the incentive. But in the current 

regulatory paradigm, that's not needed in order to get new product on the market, new contact 

lens approved and sold in the United States. But there are many other impetus and perhaps, 

again, this workshop will be such. 

RICH CLELAND: Thank you. Andrew. 

ANDREW STILAND: Thanks. I want to spend a little bit of time focusing on the role of the 

examination itself. And Dr. Chaum talked a little bit about the fact that there doesn't seem to be 

any data linking eye health to examinations. And I want to unpack that a little bit. I think there's 

been some discussion of maybe a distinction between an initial visit, and ongoing visit. 

But I want to give folks an opportunity to talk-- is there additional data that might be out there 

that would link these things. And the thing that we always want to see with data is what's the 

mechanism by which we would think there would be a link. And also examine the empirical data 

for that mechanism. So I would open this to any of the panel members to talk a little bit about 

what the mechanism for reducing risk factors associated with contact lens used by the 

examination, either initial examination, or ongoing examinations. 

EDWARD CHAUM: A correction. My point wasn't that any examination was not indicated or 

required. It's really about how often do you need to reassess the patient. So obviously, every 

patient deserves and needs an appropriate eye examination, and an inappropriate contact lens 

fitting. It's very clear that an initial fitting is important. And it's the unregulated use of contact 

lenses people, who don't get fit over the counter at a flea market or wherever who have 

significant complications we hear a lot about. 

The issue then really becomes what is effective management for that patient, and how often does 

that patient need to be seen. I would assert that patients who wear contact lenses, when they have 

difficulty with those lenses, they become uncomfortable. Their wear time goes down. Maybe 

they get a little bit of redness. They become symptomatic from the use of those contact lenses. 

And we heard, actually, today about how patients drop out of contact lens wear because they 

develop these issues.

And I think it's part of our education as eye care physicians to inform those patients that if you 

have a problem, if you're having difficulty with your lenses, if you're having difficulty with you 

your wear time, then you should come back for an examination. It's not about keeping the patient 
away from the eye care professional. It's about trying to find a balance between what is an 

appropriate periodic re-evaluation of a patient who is asymptomatic, who doesn't have clinical 

symptoms, who has good vision. 

We used to think that every patient needed a general medical examination every year. I'm 

incentivized by my health care plan to go see my internal physician every year. My health care 

costs are less if I do that. But it's very clear from the Cochrane collective publications and from 

other sources that an annual examination and annual physical examination for someone like me, 

who is asymptomatic, has no benefit to the patient. It adds health care costs to the system, it has 

no benefit. And the US Preventive Health Care Task Force, which is an independent agency that 

assesses health care utilization, came out in 2012, 2013, and recommended against routine 

annual physical examinations for people like me. 

Same thing happened with glaucoma. In 2015, the task force said, patients don't need to be 

screened for glaucoma on a yearly basis. I think that's a terrible idea for certain patients-- for 

patients who are at risk. But the routine screening of patients to look for glaucoma was 

determined by the preventive task force as having no value in preventing disease, and improving 

health care. 

ANDREW STILAND: Dr. Lakkis, seems like you want to respond to that. 

CAROL LAKKIS: Yes, I'd first like to make a comment that there are a number of things that 

can occur when you wearing contact lenses that do not actually first start with symptoms. So one 

thing that we often see as a complication in contact lens wear is asymptomatic infiltrates. 

So sometimes, the first time that these are discovered is actually during an eye exam where you 

may see a scar. And a scar in the cornea, depending on its location, may impact vision. But more 

importantly, as I mentioned previously, something like that indicates an inflammatory process is 

occurring. 

Now when inflammation gets bad, then yes, you might notice symptoms. And like we saw in the 

video from Jennifer Cope, the footballer who noticed that his eye was getting more and more 

uncomfortable. But a lot of these early changes to the tear frilm, changes to the corneal integrity, 

looking under the eyelid, and looking for early signs of inflammation in that area as well, these 

things can occur without symptoms. And as a practitioner, you have a better chance of success 

intervening earlier if you're able to actually do that rather than waiting until things actually 

progressed. And in the field of inflammation, what we understand, particularly with CIEs, is 

once you've had your first corneal inflammatory event, your chance of having another is then 

increased by 50% for the following year. 

So there is a definite need to have a comprehensive evaluation of every wearer for health and 

safety purposes. But then also, as an opportunity for re-education. So we also heard a lot this 

morning about the opportunities for modifying behavior, and there is lots of research, and lots of 

evidence that shows that when you do actually receive education, your behaviors can change. 

But it's not a long lasting and permanent thing. It requires a lot of periodic re-education to keep 
the actual information from patients relevant, and focused on their specific needs, and their 

lifestyles, and their scenarios . Themselves 

RICH CLELAND: Thank you. 

Apparently, that's a really that's a very popular view. 

CAROL LAKKIS: Yes, clearly. Thank you, everyone. 

ANDREW STILAND: One brief clarification question for Dr. Chaum. Does the American 

Academy of Ophthalmologists have a specific recommendation for the frequency of visits for 

contact lens wearers in particular? 

EDWARD CHAUM: Not that I have seen. Not in their perfect practice plan. 

ANDREW STILAND: Thanks. So the final question I want to address sort of in this area of 

examinations in particular is, there was mention of other countries that have different practices. 

Is there specific data that relates to the frequency of visits in some of the other areas that have 

different rules, versus how the US practices? 

EDWARD CHAUM: I think the data is actually pretty informative. So outside of the United 

States, although it is recommended that patients have periodic exams, depending on the country, 

every two or three years, for all intents and purposes, contact lenses are more of a commodity. 

You can buy contact lenses in any vending machine in any train station in Europe. 

And yet, if you look at excluding the Asian data, if you look at the data of the incidence and 

prevalence of keratitis in regulated areas like Australia and in Europe, what you see is that the 

incidence and prevalence of keratitis is exactly the same as it is here in the United States. The 

risk factors are behavioral, modifiable risk factors that relate to duration of use, hygiene--

sleeping with lens and so forth-- the exact same risk factors. So in countries in which FDA 

regulations do not exist, and they are less regulated, the incidence is the same. 

The one thing that is, I think, important to point out is that things have changed here since the 

original FCLCA a ruling in 2004. And so the concern at that time, as I go back and read the notes 

on it, was that we would see an increase in the incidence and prevalence of keratitis associated 

with contact lens wear if the markets were opened up to online vendors and non-eye care 

professionals selling contact lenses. That was a very significant concern. And what we've seen 

since that time is that there's been absolutely no change in the incidence and prevalence of 

keratitis in this country after the initiation of the contact lens rule. 

So I think it's very clear that the vast majority of the risk relates to behavioral use of lenses. And 

I think the biggest and most important thing that we can do for our patients is to educate them 

properly, and continue to educate them on how to wear their contact lenses properly. 

ANDREW STILAND: Are there any other-- yeah, please. 
BETH FREEBORN: I know that there is literature out of France that looked at the different 

dispensing patterns of contact lenses with opticians, optometrists, ophthalmologists, and found 

that when the patients did not undergo an eye exam, their risk for microbial keratitis was 

exponentially higher. So there is data out there about the harms that can happen with contact lens 

used without the eye exam. 

I would want to offer one other statement, which is that a lot of the literature that we're citing are 

case control studies about the impact of the visit. And what we really need is a prospectively 

done study, where we are not biased by recall bias of patients who are harmed, recalling when 

they go to see their doctor. And to do that, we would need a registry or some other mechanism to 

collect data in an unbiased way on the patient population. That's using contact lenses. 

So one of the challenges with a lot of the inferences that are made is that the data doesn't really 

support a causal inference. So we have to be very careful in interpreting the literature. 

RICH CLELAND: I'm going to intervene here just second. We've got about 10 minutes left on 

this panel, and we still have a couple of questions we want to get out there and discuss. So if the 

audience could hold their applause in between the speakers, that would save us some time. 

Thank you. 

So we were going to move into actual identification of the risks from use of contact lenses, but I 

think that's already been covered in a number of the presentations. So we don't have to spend 

much time on that. I have one question I would like to ask, and probably, I'll start with you Dr. 

Lakkis, on this question. 

When I looked through the research-- and a lot of the research is stuff that articles that you 

provided to me-- there are a number of studies that focus on microbial-- I got it right-- keratitis. 

And then there are some other studies, particularly I think the Clay study recently, that look at 

more than just keratitis. What's your view the appropriate risks that should be looked at in this? 

CAROL LAKKIS: So as we've heard about today, fortunately, microbial keratitis rates are fairly 

low relative to inflammatory event rates. So in microbial keratitis, we're looking at analyzed 

incidence rates between four and 20 per 10,000. But for inflammatory events, we're seeing rates 

anywhere between 5% and 25% of contact lens wearers per year. And Dr. Eydelman and Dr. 

Tarver can comment more than I can. 

But for understanding health benefits and risks for eye health in terms of inflammatory and 

infectious events, we can use corneal inflammatory events as a surrogate for MK, for microbial 

keratitis. And what we do often see is a lot of the similar risk factors between both. And as I 

mentioned earlier, inflammation and infection are now, the research tells us, on a continuous 

spectrum. So what might start off as what appears to be an inflammatory event could actually be 

a potentially infectious event. 

And luckily, for ourselves here in the US, and other countries like Australia, and the UK, the 

standard of care is that if you say one of these inflammatory events in a contact lens wearer, you 
treat it as if it is microbial keratitis, so that you don't take the risk that it will actually progress. 

So that that's where the data is differing. But the risk factors tend to be very similar for both. 

ANDREW STILAND: So I want to ask a fairly specific question in terms of what the role of 

point of sale might be in determining some of these risk factors. And in particular, is there data? 

If there isn't data, what the mechanism linking risk with point of sale might be. And then a brief 

comment about what factors might influence that mechanism, and how that might be changed. 

And again, open this up to anybody on the panel that might want to comment. 

CAROL LAKKIS: I could start. So there's actually some recent evidence that suggests that 

internet purchase may result in a five times higher risk of infection compared to purchasing 

through a more traditional channel. But there are other studies that don't show internet purchases 

being a significant risk factor. So I think we do need more evidence in that area. 

Going back to a previous point, more critical, I think, is ensuring that when contact lenses are 

fitted and prescribed that patients are actually obtaining that actual prescribed and fitted contact 

lens. That they're obtaining what the eye doctor has determined is the best for their eye health, 

their eye anatomy, their lifestyle choices, and needs. And so ensuring that that happens, I think, 

is a factor that plays a role in some of these epidemiology studies. 

It's also been suggested in those studies that there could be a lack of relationship with the eye 

doctor, and knowing when to go back, and see the doctor could be what is underlying that 

increased risk. So it's not the purchase process itself, but the possible education around that. 

Further research is needed. 

EDWARD CHAUM: Yeah, so there really isn't a lot of data that suggests that there's any 

relationship between the development in keratitis and the point of purchase. There was a study 

back in 2004-05 Stapleton's a group in Australia, which has done a lot of work in this area, that 

suggested that there might be an association. And that study was repeated and was published 

back in 2016, and showed that there was no association of point of purchase related to that 

development of keratitis. 

The study that Dr. Lakkis is referring to is a recent study by [INAUDIBLE], which is, in my 

view, a fairly weak study in that the data that suggests that there's a five-fold increased risk of 

developing keratitis from purchase online. Has to be balanced with the fact that the other 

findings in that paper were that there was a three and a half fold increased risk if my mother 

purchased it for me. And there was a three and a half fold increase risk if the young person lived 

on their own as opposed to having a roommate. 

So these sort of weak associations really are, I think, statistical noise, and really don't add to the 

literature in a meaningful way. We just don't know. But what we do know is that for the many, 

many, many studies of case controlled keratitis that have been published over the last 25 years, 

there is no real strong evidence that there's any relationship between point of purchase and the 

development keratitis. 
CAROL LAKKIS: Can I just clarify, I was actually referring to the Stapleton's studies for the 

five time increased risk. And the more recent Stapleton publication is looking specifically at 

daily disposables, where point of purchase was not a significant risk factor in reuseable wear as it 

was. 

RICH CLELAND: The reuseable one-- please, you know this better than I do-- I thought the 

reuseable one with the total was the 2008 study. So it's an older set of data, it's older than 10 

years at this point. And the while the 2017 study didn't show a relationship for a specific type of 

lens-- that's kind of, you don't know what you would do if you had looked at all lenses there at 

this point. 

CAROL LAKKIS: I think it's important to look at the body of evidence overall. We don't look at 

any one individual study, as Michelle was also saying. You need to actually look at everything--

the information that's coming from all different countries, as well as different types of studies 

that are conducted, and interpret that overall, rather than just honing in on one particular 

outcome. 

RICH CLELAND: I have one last question, because we're out of time. But I need to at least 

touch on this for a second. And if somebody has a one minute response, I will take it. 

Cosmetic contact lenses. How is that affecting some of these studies? Is the sale of those types of 

lenses OTC reached such a proportion that they're affecting the results the data that we're seeing 

at this point? 

MICHELLE TARVER: So a lot of the studies have incorporated or collected information about 

decorative lenses, and we do see a higher risk with decorative lenses. We've seen patterns within 

our NDR database also with decorative wearers having higher impacts on their vision. The 

challenge, as I already alluded to, is that we don't have a good denominator, and we don't really 

know the true incidence rate associated with the different types of devices, because we haven't 

systematically studied it. And I'll make a plug once again for a registry lenses so that we can 

have some answers to these questions that we're all trying to understand. 

RICH CLELAND: OK, thank you. 

All right. We are going to break now. I want to thank all of my panelists for an excellent 

discussion, and I apologize for all my mispronunciations. But thank you again. 

ANDREW STILAND: And we will reconvene at 11:15. 

RICH CLELAND: 11:15.