The Soft Lens, 50 Years OnCheck out articles commemorating the soft lens's anniversary:
Material Gains: 50 Years of the Soft Contact Lens
Manufacturing a Brand-New Industry
Advances in Optics Drive Soft Lens Success
Optometrist Christine Sindt recalls the first set of soft contact lenses (CLs) she wore in the mid-1980s. These yearly-replaced lenses came in vials that doctors had to often carefully dig out with a special, sharp tool, sometimes cutting themselves in the process. And patients, like Dr. Sindt, tried to get as much wear out of their costly contacts as possible.
“I remember seeing visible deposits on the lenses, and I tried to pick them off with my fingernails. We didn’t think as much about lens solutions back then, since they were mainly used to keep the lenses wet and from dehydrating.”
Additionally, these early soft CLs sometimes turned different colors if wearers took certain medications or used eye drops, Dr. Sindt says.
“People wanted to keep the lenses as long as they could, because contacts were so expensive back then,” she explains.
Today, the soft contact lens has undergone a dramatic evolution from its inception to now offering weekly, biweekly, monthly and daily disposable lens replacement options, including healthier schedules, more advanced materials and customized optics for specialty lens patients.
As the first soft contact lens to enter the US market celebrates its 50th anniversary, contact lens experts share some milestones, lessons learned, and their thoughts on the robust current market.
Soft Lenses Make Their Big Debut
Soft lenses became commercially available in London in 1970 through Global Vision (de Carle & Galley) and Contact Lens Manufacturing (Clulow & Cordrey), and their entry into the market was quickly followed by larger scale manufacturing and global supply from Bausch + Lomb with the Soflens in 1971. This was followed by launches from Hydron Lenses and Titmus Eurocon a year later, says optometrist Jill Woods, head of clinical research in optometry and vision science at the University of Waterloo’s Centre for Ocular Research and Education.
Within just a few years, multiple soft lens products entered the market, and some were spun-cast and others lathed, she explains.
“The introduction of soft lenses led to a rapid growth in CL use worldwide,” Dr. Woods says. “Soft lenses were adopted very quickly because of the vastly improved comfort they offered compared to the rigid lenses of that time, which were made of PMMA.”
From a design and material perspective, the early lenses were quite crude by today’s standards, but nevertheless, a gigantic revolutionary breakthrough considering the limitations with lens technology that existed back then, says Joseph Shovlin, OD, of Scranton, PA, past president of the American Academy of Optometry.
Due to the high costs of soft contact lenses in the early days, it was unusual for people to have a spare pair, Dr. Woods says. Patients kept their single set of lenses for a year or longer, and very high-volume CL practices carried only a small inventory of their most popular brands in a handful of powers to offset the one or more weeks it took to receive a new order, she says.
Disposables Alter the Marketplace
The 1970s and ’80s were decades of significant improvement in overall comfort and physiologic response, Dr. Shovlin says.
In 1984, Johnson & Johnson Vision Care (then called Vistakon) initially purchased technology from the Danish-based Synoptic group for the Danalens, a high-water extended wear lens, which the company paired with etafilcon A, a material it had acquired a few years earlier.1
After three years of development, Vistakon launched the seminal Acuvue lens in 1987. The Acuvue disposable was initially introduced as a two-week extended-wear lens to be worn and then thrown away.2
Once it was proven that disposability could work, other manufacturers rapidly launched their own frequent replacement lenses in the now-familiar blister packs.1
Following Vistakon, Bausch + Lomb added the Sequence in 1988, while Ciba launched the Newvues disposable lenses.3 In 1990, Ciba introduced Focus monthly lenses and Bausch + Lomb launched Medalist four-packs for quarterly replacement.3
The 1980s and ’90s were also a time of great strides in innovation, and many drivers were behind the uptick in soft lens use, Dr. Shovlin says.
“It was the quest pushed to provide better products looking to improve upon what was already deemed to be revolutionary. Things evolved based primarily on the excitement and enthusiastic response from both patients and practitioner acceptance for this new modality,” he explains.
Still, challenges arose with the new disposable options, including poor lens centration, deposit-related disease such as giant papillary conjunctivitis and physiologic findings with lens-induced edema, according to Dr. Shovlin. Manufacturers responded with new materials and designs, frequent lens replacement options and more effective solutions that caused less toxicity, he adds.
Despite the lenses growing in popularity, not everyone was on board initially.
“Some doctors still had that value driven thought process to keep the lenses as long as possible, and they believed, if patients cleaned the lenses really well, they didn’t need to replace them that frequently, Dr. Sindt says. “But there were a lot of health problems that ensued.”
The rise of disposable lenses also changed the way ODs practiced.
The most revolutionary aspect of disposable lenses was that suddenly, it was practical for the practitioner to stock an inventory on site. Instant access not only improved customer service to existing wearers, but it also made CLs more accessible and facilitated impromptu lens trials,” Dr. Woods explains.
EW Lenses Surge—Until Infections Spike
Extended wear (EW) lenses hit the market in 1981, and the first ones were for aphakic patients after cataract surgery, since IOLs had not yet hit the mainstream, says optometrist Michael Ward, director of contact lens services at Emory University.
“If you had a mono aphakia patient with too much distortion, it was wonderful when extended wear first came out, but then we started to see the complications with the lens,” Dr. Ward says.
Once a popular choice, extended wear lost favor in the late 1980s, when researchers found a much higher incidence of ulcerative keratitis with this modality compared with daily wear.4 As such, manufacturers at the time voluntarily reduced allowable wearing times from 30 to seven days.5
Despite its waning popularity, extended wear saw an uptick in the early 2000s when manufacturers turned to silicone hydrogel material, which overcame earlier EW problems, including hypoxia (read more about SiHy lenses ahead).5
Today’s modern designs have followed suit and adapted with a focus on safety and the need for oxygen to the cornea and a high Dk/t of 125 x 10-9.6
Embracing the Disposable Concept
In 1996, Bausch + Lomb was faced with a class action lawsuit that alleged the company’s SeeQuence2 lens under different brand names, including Medalist, Optima FW and Criterion Ultra FW, were essentially the same, yet being sold at different prices.
“They had a quarterly replacement vs. a monthly replacement, vs. a two-week replacement, and they were all the same lens,” Dr. Sindt explains. “That became a shocking idea to the industry. That was really the turning point for people to start thinking lenses could be made less expensively at the same quality, and maybe we should be replacing these lenses more frequently.”
Lens Care Updates Keep Pace with Soft CL Innovations
As soft contact lenses have morphed for the better over the past five decades, their care and cleaning systems had to also change to keep up with the new materials and wearing regimens.
“It’s been a very interesting evolution that we’ve gone through,” says Dr. Ward.
Like the earliest soft CLs, the first care systems were rudimentary. Additionally, little was known about the potential for soft lenses to cause infection, Dr. Woods adds.
Unlike PMMA lenses, it was understood that the first generation of soft CLs needed to be stored wet, and initially, saline was thought to be sufficient, Dr. Woods explains.
“Very early disinfection involved boiling the lenses in saline. It was quickly recognized that a better disinfection was required. To achieve better cleaning and disinfection, when soft lenses were dispensed, they were accompanied by an arsenal of lens care items that resembled a chemistry set,” Dr. Woods says.
The first soft lens care disinfection systems were multi-stepped and heat-based, says Dr. Ward. Early soft lens wearers had to use a daily cleaner, rinse the lens with homemade saline and then put the lens and saline into a heating unit that was plugged into an electrical outlet for disinfection.
While the heat system was effective for the most part, it was eventually taken off the market due to the homemade saline, which led to a rash of Acanthamoeba keratitis cases that became so unbearable to the afflicted, a number of people had their eyes enucleated, Dr. Ward explains.
Early lens disinfection also consisted of enzyme tablet cleaning. This step helped remove enzymes that bonded with amino acids that attached to the lens. The buildup of protein over time became an irritant source that caused inflammatory conditions such as giant papillary conjunctivitis, Dr. Ward says.
Heat disinfection was quite effective but had its share of issues, Dr. Shovlin says. “Not all lenses that were being developed could be heated, deposits accumulated readily and the heating process was somewhat labor intensive. For these reasons, chemical disinfection was deemed essential,” he says.
Heat lost favor with clinicians in the early 1980s with the introduction of hydrogen peroxide/oxidative disinfection and new preservatives being used for disinfection, Dr. Shovlin adds.
These new chemical cleaning products may have seemed like an initial breakthrough from the previous heating method, but they still caused problems in some patients. The chemicals could be harsh, and lenses required a saline rinse before being stored overnight in the disinfecting solution, followed by another saline rinse in the morning before lens application, Dr. Woods says.
Additionally, wearers still had to do an enzymatic treatment once a week to get rid of proteins so the lenses would last longer.
Optometrist Jason Miller recalls getting his first pair of contacts in the mid-80s and the myriad cleaning steps that went into taking care of them, including the weekly enzyme step. Despite following the protocol, trouble still arose when he had an adverse reaction to a lens cleaning solution that contained thimerosal and his eyes turned red.
In addition to thimerosal, the early chemical products were preserved with chlorhexidine and benzalkonium chloride. Despite the saline rinsing, a high number of allergic reactions occurred, which caused red eyes, corneal staining and infiltrates, tarsal changes and discomfort, Dr. Woods says.
In response, the industry in the early 1980s developed 3% peroxide overnight disinfection systems, with the peroxide neutralized in the morning by diluting or adding a catalyst. These two-step peroxide systems were effective disinfectants and less toxic to the eye; however, the surfactant cleaner was still necessary to clean the lens prior to overnight disinfection.
With these systems, the lens was first cleaned by rubbing with a surfactant cleaner, the cleaner was then rinsed off with a saline solution and the lens was placed in peroxide in a special upright, basket-style case and left for eight hours, typically overnight. In the morning, the peroxide solution was discarded and a neutralizing solution was poured into the case. This solution neutralized the peroxide over a specified period of time, often as short as 10 minutes, which rendered the lens safe and comfortable to apply, Dr. Woods says.
However, there was an inherent risk with these two-step systems—the potential for patients to forget the neutralizing step and insert the lenses in their eyes directly from the peroxide—which could cause a stinging response or even corneal fluorescein staining, lid swelling or ocular redness.
Additional peroxide systems were developed using other neutralizing systems, such as dilution, thiosulfate and catalase.
“Hydrogen peroxide remains an excellent lens care product, and when used appropriately, it both cleans and disinfects. It may be the best option for reusable soft and rigid specialty lenses,” Dr. Shovlin says.
MPS Makes a Splash But Encounters Early Trouble
Toxicities and allergic reactions commonly noted in chemical solutions were the driving force and need behind the development of new forms of chemical disinfection and multipurpose solutions (MPS) with today’s more friendly preservatives, Dr. Shovlin says.
“Multipurpose solutions were very revolutionary at the time,” Dr. Miller adds. “Patients could cut back on steps to clean their lenses, and the solutions were effective. Multipurpose solutions were easier to use, and patients were more compliant.”
Although the rise of MPS solutions put the disinfectant and cleaner all in one bottle, the early ones went through a series of gyrations, according to Dr. Ward.
By the mid-2000s, a number of MPS solutions had to be reformulated due to a rash of infections, including Complete Moisture Plus MPS (Abbott Medical Optics, now J&J), after the CDC discovered some wearers contracted Acanthamoeba keratitis. Bausch + Lomb also recalled and soon thereafter discontinued its Renu with MoistureLoc after an outbreak of Fusarium keratitis.
“Industry has done a very good job of correcting the problems they had in the past,” Dr. Ward says.
“No Rub” Hype
When many MPS products first launched, it was thought rubbing the two-week or one-month replacement lenses for few seconds after removal and prior to soaking could be dropped, Dr. Woods says. This “no-rub” brought strong marketing campaigns, touting how easy the products were to use.
“Unfortunately, it quickly transpired that the physical act of rubbing the lens was a significant step in reducing bacterial load on the lens to a level that the care product could manage. In many instances without rubbing, the lens was being re-worn with higher than ideal contamination,” Dr. Woods says. “This understanding, coupled with rising case reports of serious corneal infections, led to a swift return to practitioners recommending the rubbing step.”
New Materials Spur MPS Changes
The evolution of the MPS included changes to chemical compositions aimed at reducing the ocular response while maintaining cleaning and disinfection efficacy. The main improvements included new preservatives that were larger than the low molecular weight chlorhexidine and thimerosol used in the previous disinfection products, Dr. Woods says.
Other important updates: Bausch + Lomb pioneered the use of PHMB (Dymed) in its Renu products, soon followed by Alcon incorporating polyquaternium-1 (Polyquad) in its Opti-Free range. Other recent MPS additions include Aldox, alexidine and povidone-iodine, Dr. Woods says.
“The multipurpose solutions we have today are really good,” adds Dr. Ward. “The current generation of products is safe, non-toxic, and really refined.”
Another driver behind the updates in MPS solutions included the ushering in of new materials. Traditional soft hydrogel CLs made from HEMA polymers took a backseat when silicone hydrogels were introduced, and MPS solutions had to adjust as SiHys absorb more oils since they are lipophilic and are harder to keep clean, Dr. Ward adds.
Lens Care Freedom with Dailies
One of the most significant milestones in soft CLs has been the growth of single-use, daily disposable soft lenses, which eliminates the need for lens care solutions.
“We don’t have the toxicities we used to see. And now with daily disposables, there’s no need to use solutions,” Dr. Ward says. “We used to say the solution is more likely to cause the complication than the lens choice.”
Daily Disposables Disrupt the Market
Vistakon launched the first daily disposable hydrogel lenses in 1994, which eliminated solution issues and also reduced the risk of complications, infections and deposits.
Despite some initial hesitancy by doctors to recommend this “pricey” replacement option, Dr. Sindt says dailies quickly caught on.
“I think our whole society transitioned to disposable,” Dr. Sindt says. “People don’t want to reuse things. They want everything new all the time, and the concept of healthcare became very important. We don’t reuse bandages or medical equipment, so why reuse a CL?”
As more patients and doctors become experienced with daily disposables, their popularity will continue to increase, predicts Justin Bazan, OD, of Brooklyn, NY. “It becomes apparent that, in nearly all comparisons, they are superior to a planned replacement contact lens.”
Still, current challenges include the expansion of parameters for certain wearers, including those wanting torics or multifocals. “We are at a point now where the vast majority of our patients have the option of wearing a daily disposable, but there is still a small subset that doesn’t have the option. Financial, manufacturing and logistical considerations come into play as to how soon we will have a daily disposable option for that last group of patients,” Dr. Bazan suggests.
SiHy Lenses Change the Material Landscape
Considering CL material, the evolution of SiHy lenses was enormous, Dr. Sindt says. “That was probably the biggest revolution we’ve had in contact lenses, maybe ever.”
In 1999, Ciba Vision launched Focus Night & Day (lotrafilcon A) with 175 Dk/t, and Bausch + Lomb came out with PureVision (balafilcon A), with 110 Dk/t, which both exceed the oxygen transmissibility requirements needed to avoid overnight corneal swelling.5
Silicone hydrogels represented a revolution in contact lens materials because they could transmit higher levels of oxygen through the lens, and this transmission no longer relied on the water content of the material as in the previous generation of hydrogel lenses, explains Dr. Woods.
Prior to SiHy lenses, frequent replacement soft hydrogel lenses were available, but hypoxia-related complications existed with full-time daily and extended wear.
“There have been definite health benefits attributed to the higher delivery of oxygen to the cornea. While serious corneal infections and inflammation have not been eradicated, their severity has been reduced and recovery rate improved,” Dr. Woods says.
Soft CLs’ Future Looks Bright
Today’s soft contact lens replacement cycles have expanded dramatically to include myopia control, torics, multifocals and specialty lenses.
“What I’m really excited about is the idea of correcting higher order abberations and making the lens customizable for the patient, whether it’s the material or the coating on the lens,” Dr. Sindt says. “We’re starting to see things like Hydra-PEG on soft lenses, and customized optics. I think all of this is going to lead to better health, a better wearing experience, and it’s going to tie the patient more closely to the doctor since the patient will see the value of the product the doctor is prescribing. That’s what really excites me about the future of where we’re going.”
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4. Poggio EC, Glynn RJ, Schen OD, et al. The incidence of ulcerative keratitis among users of daily-wear and extended-wear soft contact lenses. N Engl J Med. 1989;321(12):779-83.
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