Marking a Milestone
in Contact Lenses

MAR. 1996

It was the year the Baltimore Colts beat the Dallas Cowboys in the last five seconds of the Super Bowl. Billie Jean King won the women's singles title at the U.S. Open Tennis Championships. Simon and Garfunkel took home two Grammy awards for "Bridge Over Troubled Waters." And short-shorts called hot pants became the latest fashion craze.

But for eyecare professionals everywhere, 1971 is best remembered as the year soft contact lenses debuted in the United States.

On March 18, 1971, the U.S. Food and Drug Administration approved Bausch & Lomb's application to market soft contact lenses in the United States, marking the end of a five-year journey that began in Czechoslovakia.

VISIONARIES & RISK-TAKERS

In 1965, an ophthalmic salesman named Ernie Swart told B&L management about a hydrophilic polymer and a new manufacturing technique invented by a pair of Czechoslovakian scientists, Otto Wichterle and Drahoslav Lim. A year later, the company acquired the rights for the polymer, called poly 2 HEMA, along with a manufacturing process called spincasting from the National Patent Development Corp. in New York. Thus was the Soflens Project launched with William Coombs at the helm.

"My training was in physics and engineering, so I was fascinated with the spincasting process," said Coombs, now retired and living in Florida. "The idea to gel a lens while it was spinning was definitely new."

Coombs, who was director of central research and later became vice president of technical operations, was instrumental in piloting the soft contact lens through the FDA's circuitous approval process which was complicated by the agency's unexpected decision to define the lens as a drug.

"There were many people involved in the project," said Coombs. "It was a great team effort, and the management of the company was very much a part of that team."

In April 1967, Coombs and a group of B&L executives that included future-CEO Daniel G. Schuman, went to Prague to visit the chemists and engineers who had developed the HEMA material and the spincasting methods. They also met with the physicians who had done clinical trials with the soft lens. Convinced of the merits of the material and the process, they bought a manufacturing machine and shipped it to corporate headquarters in Rochester.

THE BREAKTHROUGH

With the material, the manufacturing process and the machine now under one roof, the soft lens team began their evaluations. Chemist Dominic Ruscio had been with the company for about six months when he and engineer Wayne Manning were tapped to join the project.

"Essentially, the ophthalmic division concluded that there was not a viable manufacturing process. So they gave it to Wayne and me to tinker with.

"We quickly learned that the machine process was really not a process at all. Yields were extremely low or nonexistent and the quality of the lenses highly variable.

"I don't want to diminish the technology that Wichterle developed in any way," said Ruscio, now project director for research and development. "The inherent process of spincasting was a wonderful process, a way to make a contact lens very quickly at an extremely low cost. And the HEMA material was well-suited for contact lenses. Wichterle brought together the technical foundation that was ideally suited for mass producing contact lenses.

"Basically, Wayne and I started experimenting with various parts of the process," said Ruscio. "I think a key was incorporating photopolymerization. This made the monomer very stable and the polymerization more uniform and controlled.

"When we were able to put the monomer into the mold and almost every time get a consistent shape, we knew we had a breakthrough," said Ruscio.

R&D efforts translated into higher yields and a more consistent product, says Carl Sassano, who joined the company's marketing team in 1973 and is now president of B&L's contact lens division.

"The first machine produced one lens at a time with a yield of about 20 percent," said Sassano. "In other words, if we started 10 lenses, we'd end up with two. By the time the company launched Soflens, we were using an 8-table machine with yields of 80 percent. Today we can produce 32 lenses at a time with 90 percent yields."

EARLY TRIALS DISAPPOINTING

Massachusetts ophthalmologist Perry Rosenthal was among the first group of principal investigators for B&L.

"I had tried some early soft lenses," he said, "but they were big, clunky, tire-like things that were not acceptable. B&L assured me that their product was different, and it was.

"I was disappointed in the performance of the first lenses," said Dr. Rosenthal. "These lenses caused corneal edema of a minor variety and they didn't center well, so vision wasn't great. But, by the time they went on the market, the lenses were greatly improved. The 'N' and 'S' lenses performed far better and B&L subsequently made tremendous progress as we and they learned more about the physiologic effects of these lenses and their improved capabilities.

THE FDA REDEFINES THE LENS

As the research and development team continued to fine-tune the manufacturing process, the company started developing marketing initiatives.

Then, during the week between Christmas and New Year's (1968-69), the FDA informed B&L that the agency considered the soft contact lens a drug and the company would have to submit a new drug application with additional clinical data.

"When the FDA called the lens a drug, that was a shock," said William Coombs. "By then, we thought we had pretty well completed all the necessary clinical studies and we were talking about marketing the lens.

"After considerable further effort and many more meetings and submissions, we received approval to market the lens in spring 1971."

At that time, there were 21 people employed on the project, including secretaries, technicians and others who processed, inspected and packed the lenses.

MARKETING THE FIRST SOFT LENS

Carl Sassano believes three people were most instrumental in bringing the soft contact lens to market -- Daniel Schuman, who had the foresight to bring the technology to the United States, William Coombs, "the eyes and ears of the technical side of the business," and John Williams who crafted the marketing strategy.

"In the early days, the soft lens business was an island in a sea of instruments and ophthalmic frames," said Sassano. "John Williams helped convince Dan Schuman to make soft lenses a separate business, not a product line of the ophthalmics division. This was a key move. If they had made it a product line, it would have died."

"We introduced Soflens in selected cities in the Pacific northwest," recalled Coombs. "By Thanksgiving, we had completed the nationwide introduction."

The national rollout was highlighted by educational symposiums and training classes, which were as much training sessions for the sales force as for the practitioners. Less than six months after the FDA approval, the company reported $1 million in sales of Soflens. (Today, industry sources estimate that as many as 600 million soft contact lenses were sold worldwide in 1995.)

SOFT LENSES TAKE OFF

Although B&L brought the soft lens to the United States, over the years manufacturers have leap-frogged over one another as they developed and introduced new materials and designs in rapidfire succession.

American Optical, which later was acquired by CIBA Vision, introduced the first therapeutic soft lens in 1973. In 1974, Continuous Curve Contact Lenses gained FDA approval for the first lathe-cut soft contact lens. The company, founded by Donald Brucker in 1960, merged with Barnes Hind (now Pilkington Barnes Hind) in 1980. The Hydrocurve soft toric lens debuted in 1978, and the same year, Wesley-Jessen received FDA approval of phemfilcon A, the basis for their DuraSoft line.

Soft lens firsts came at a dizzying pace during the 1980s. The FDA approved the first cosmetic extended wear lens produced by both Barnes Hind and Cooper. CIBA Vision launched the first visibility tinted soft contact lens, and Syntex Ophthalmics (now part of PBH) introduced CSI, the first non-HEMA soft lens.

In 1981, Johnson & Johnson acquired Frontier Contact Lenses, Inc., a hard lens manufacturer that had started producing soft lenses in the late-1970s. Shortly thereafter, the company was renamed Vistakon.

In 1982, the FDA approved CIBA Vision's Bisoft bifocal lens, although B&L and Wesley Jessen sold soft bifocals in 1981. And in 1986, Wesley-Jessen introduced the first soft lens that could change eye color.

By 1987, patients were seeking even more convenience in lens care and Vistakon seized the opportunity with its introduction of the first disposable contact lens. In early 1995, the company launched the first daily disposable contact lens nationwide.

THE FUTURE

"Throughout most of the '70s, the goal of soft contact lens design was to expand the number of eye parameters," said Carl Sassano. "Today, the market has told everyone that disposability as a concept is the future. Over the next 5 to 10 years, I think people will seek their own level of wear and the average person will wear their lenses three to five days a week.

"If I could make the ideal contact lens, I would make it a semi-soft, almost no water, no deposit lens about 14mm in diameter with an 8.7 base curve. I'd make it semi-soft because the more rigid the lens the better the visual acuity; and low water reduces risk of infection.

Dominic Ruscio is currently evaluating products in the extended wear category. "I think there is the potential for significant improvements in materials that should translate to improvement for the patient," he said.

While many of his colleagues look hopefully toward the day when continuous wear is a reality, Dr. Perry Rosenthal believes this goal may be unattainable.

"The biggest obstacle to wearing soft contact lenses is that they dry on the eye and become uncomfortable," he said. "I believe the next major advance in soft lenses will be a lens that maintains and binds water to it so strongly that it avoids this drying problem.

"I believe that the Holy Grail of soft contact lenses, which is to enable patients to wear them continuously and safely, is beyond our reach. It interferes with the basic defense mechanisms that protect the eye during sleep.

"I hate to be a naysayer," he said, "but I don't think safe, extended wear soft lenses are in our future."

Rodger Kame, on the other hand, is optimistic the industry will provide such a lens.

"I believe the future holds the optimum," he said. "a true continuous wear lens where oxygen needs are met and resistance to deposition needs are met as well.

THE AFTERMATH OF THE SOFT LENS REVOLUTION

Bob Koetting likes to joke that, not only did soft lenses cost him money, but they took all the fun out of fitting contact lenses.

But the most profound effect of the soft contact lens, says the St. Louis O.D., is that it propelled the practitioner out of the role of contact lens mechanic to true eyecare professional.

"Up to that time, contact lenses were mechanical devices and laboratories were machine shops," said Dr. Koetting. "There were no FDA controls; there was no understanding of hygiene. The labs had doormats on the way out so you could wipe the dust from your shoes when you left.

"The soft lens taught us to think about physiology and chemistry rather than adaptation, which was our main concern with hard lenses," he said.

In 1971, Rodger Kame, O.D., of Los Angeles was specializing in contact lenses when few practitioners were, so he was among the first O.D.'s on the west coast to receive the new Soflens.

"The soft lens was a major breakthrough," he said, "but there was a considerable learning curve. It was challenging to fit soft lenses then, and in the first 10 years there were problems with GPC, oxygen transmissibility and solution preservative reactions.

"When soft lenses came along, we were just starting to develop the skills to modify and fit hard lenses and to understand the physiology of the eye," said Dr. Kame. "If the gas perm lens had come first, many of these problems would already have been addressed."

Perry Rosenthal, M.D., was an investigator for B&L's soft lens project for almost three years and later served as a consultant for the company. Although he focused his creative energies on developing the gas permeable lens at the time everyone else was concentrating on soft lenses, Dr. Rosenthal said his private practice today is divided about 50/50 between soft lenses and RGPs.

"I feel that soft lenses have an important place in practice," he said, and noted he and several colleagues recently developed a new hydrogel that they hope to bring to market soon.

If you're wondering how Bob Koetting lost money with soft contact lenses, he explains it this way:

"Twelve of us put up $100 each to learn how to make the HEMA material and soft lenses. I think I got some formulas, but I never did anything with them. Five of the investors became multimillionaires. I just lost my $100."

As for missing out on all the "fun," Koetting says, "Until soft lenses came along, we used to get together to talk about how to make lenses, what designs to try, what base curves to use. Then along came soft lenses and we had nothing to do."

SOLUTION EVOLUTION

Lens care has come a long way from the early days of salt tablets and heat disinfection. Remember when your patients mixed solutions themselves? Remember the lack of compliance and the risks to their ocular health?

Then came thimerosal, improvements in heat disinfection, and the first preserved chemical disinfecting solutions. This was a step in the right direction -- it offered sterile, preserved products -- but, for some eyes the preservatives spelled irritation.

In the early 1980s, thimerosal gave way to solutions for sensitive eyes. Gentler preservatives such as sorbic acid came into favor, as did sterile, preservative-free solutions and hydrogen peroxide systems with instructions for neutralization and dilution complex enough to stump the most conscientious patient.

Not only were solutions more complicated to use, they were complicated to buy. By the mid-1980s, a proliferation of brands, regimens and products within each regimen made the patient's visit to the eyecare section of a drug store a dizzying experience.

Patients' lives were simplified when the first multipurpose solution, B&L's ReNu, came on the scene. Today, as patients and practitioners alike now expect the combination of efficacy and simplicity in more convenient solutions, multipurpose products have become the standard of lens care.