...continued from What's New in Contact Lenses

FTC Warns Sellers of Cosmetic Contact Lenses

WASHINGTON D.C., July 2006 — The U.S. Federal Trade Commission has warned on-line sellers of cosmetic contact lenses that they must comply with regulations requiring verification of prescriptions issued from an appropriate eye care professional.

The FTC sent 18 warning letters in late June 2006 to on-line sellers of cosmetic or decorative contact lenses, primarily because their web sites erroneously state that such contact lenses do not require a prescription. An FTC news release also indicates that these on-line entities appear to be selling decorative contact lenses without requiring a prescription from the buyer or verifying that such a prescription exists.

In November 2005, the U.S. Congress responded to concerns regarding safety hazards of unregulated contact lenses by amending laws to include colored or decorative contact lenses as restricted medical devices.

"...Decorative contact lenses present significant risks of blindness and other eye injury if they are distributed without a prescription or without proper fitting by a qualified eye care professional," according to the U.S. Food and Drug Administration.

The FTC says contact lens sellers who violate related federal regulations face civil penalties of up to $11,000 per incident.

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New CIBA Vision Contact Lens Case Protects Against Contamination

ATLANTA, June 2006 — Contact lens wearers now can receive extra protection against potential eye infections through use of CIBA Vision's new Pro-Guard Lens Case, infused with an antimicrobial agent that helps prevent contamination.

The contact lens case contains silver atoms that have been electrically charged (ions), shown in clinical trials to help reduce the possibility of outside contamination within the case by 40 percent.

"Lens cases are quite vulnerable to contamination," said Karen Gough, president of the Americas Region of CIBA Vision, with headquarters in Atlanta. "For example, data tell us that a large percentage of contact lens wearers rinse their lens cases with tap water, which could be a source of contaminants. It's therefore not surprising that lens case contamination occurs with up to 80 percent of contact lens wearers."

The contact lens case, used with CIBA Vision's AQuify Multi-Purpose Solution, has been cleared for marketing by the U.S. Food and Drug Administration. CIBA Vision provides the Pro-Guard contact lens case free with purchase of the contact lens solution.

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Avoid Swimming While Wearing Contact Lenses

BOSTON, May 2006 — With summer season upon us, many swimmers who wear contact lenses likely will feel the urge to cool off by plunging into an ocean, swimming hole, or pool.

But swimmers who leave in their contact lenses face a significantly increased risk of potentially serious eye infections from contaminated water or eye irritation from pools where chemicals such as chlorine can be absorbed by lenses, according to the New England College of Optometry and May 2006 issue of Contact Lens Spectrum.

If you absolutely must wear your contact lenses in water, consider preventive measures such as wearing watertight goggles or immediately disposing of any contact lenses exposed to water. Also, ask your eye doctor for more detailed information about safety and wearing of contact lenses in and around water.

You can find more information on this website about watertight swim goggles, as well as the dangers of swimming while wearing contact lenses.

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Fungal Eye Infection Outbreak May Be Linked to Contact Lens Solution

ROCHESTER, N.Y., April 2006 — Bausch & Lomb (Rochester, N.Y.) has announced that U.S. shipments of ReNu with MoistureLoc contact lens solution have been stopped while investigations are made into a possible link between the product and an outbreak of fungal keratitis eye infections that usually are rare.

The U.S. Centers for Disease Control and Prevention (CDC) released a report in early April stating that 26 of the first 30 eye infection cases investigated involved contact lens wearers who had used ReNu with MoistureLoc. More than 100 U.S. cases of the eye infection caused by Fusarium fungus had been reported to the CDC at the time the first report was released.

While Bausch & Lomb officials said they were halting shipments of the contact lens solution from the company's Greenville, S.C. manufacturing plant as a safety precaution, no evidence from extensive laboratory analysis of the product indicated that ReNu with MoistureLoc was the source of the infection.

In Singapore, Bausch & Lomb also withdrew ReNu with MoistureLoc after investigators noted an association between use of the product and development of the fungal eye infection. News reports say that, while the eye infection still is relatively rare, it can be difficult to treat and potentially can cause serious damage to the eye's surface (cornea).

Read comprehensive coverage and updates about fungal eye infections among contact lens wearers.

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Contact Lens Corrects Vision Errors Caused by Trauma or Eye Surgery

CARLSBAD, Calif., March 2006 — SynergEyes Inc. (Carlsbad, Calif.) has received U.S. Food and Drug Administration clearance for marketing its post-surgical SynergEyes PS hybrid contact lens, designed to correct vision errors caused by trauma or eye surgery.

The contact lens, which will be available in 2007, is considered a hybrid because its composition varies from strong but soft at the outer edges to more rigid in the center. This concept has been used as a platform for other lenses that include SynergEyes for correction of astigmatism, farsightedness, and nearsightedness.

SynergEyes KC for correction of an eye condition that causes bulging at the eye's surface (keratoconus) will be marketed beginning in May 2006. The company plans in 2007 to launch a lens for correction of presbyopia known as SynergEyes M.

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CIBA Vision Launches Daily Disposable Color Contact Lenses

ATLANTA, March 2006 — Marketing has begun for the first daily disposable colored contact lenses available in the United States, known as FreshLook One-Day, introduced in late February by CIBA Vision (Atlanta).

FreshLook One-Day combines the material and design of CIBA Vision's Dailies contact lenses with the color patterns found in the company's FreshLook ColorBlends line. The four most popular ColorBlends colors — hazel, blue, green, and gray — are available in FreshLook One-Day.

"FreshLook One-Day color contact lenses...present a simple, inexpensive option for all contact lens and spectacle wearers who want to try an additional look," said Jeff Cohen, North America vice president of marketing for CIBA Vision.

CIBA Vision officials said their research and surveys indicate that about 33 percent of people who wear soft contact lenses already wear or are interested in soft color contact lenses.

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Bill Restricting Contact Lens Trade Now Pending in Utah Legislature

SALT LAKE CITY, Utah, March 2006 — A new bill restricting contact lens brands available for state optometrists to prescribe was introduced in early 2006 in the Utah state legislature.

Opposed by the Utah Medical Association, the proposed bill would require individual contact lens manufacturers to seek annual state certification verifying that products are equally available to all distribution channels including Internet and mail order outlets. The Utah state attorney general's office would monitor contact lens manufacturers by keeping and publishing lists of certified products.

The Indiana State Optometric Association reported in early 2006 that similar legislation backed by contact lens retailer 1-800 Contacts introduced in the Indiana state legislation died without action in committee. If the bill had passed, Indiana optometrists would have been unable to sell any contact lens brand that did not have specific state certification.

Contact Lenses Today reported that contact lens manufacturers failing to comply with Indiana state certification requirements could have faced penalties of up to one year's prison time and a $5,000 fine. The Utah bill says penalties could include a $1,000 fine levied against manufacturers for each violation and license suspension for anyone prescribing an uncertified contact lens.

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New Acuvue Oasys Contact Lens Receives FDA Approval
for Extended Wear

JACKSONVILLE, Fla., January 2006 — A new Acuvue Oasys contact lens designed particularly to increase comfort for people with dry eye received an additional U.S. Food and Drug Administration approval in late 2005 for extended wear up to seven days. Previously, the lens was FDA approved for daily wear only.

Vistakon, a division of Johnson & Johnson Vision Care Inc. in Jacksonville, Fla., markets the Acuvue Oasys made of a silicone hydrogel material known as senofilcon. The manufacturer says the lens is 50 percent smoother than other silicone hydrogel contact lenses. And the Hydraclear Plus wetting agent used with the lens is designed to provide even more comfort.

Acuvue Oasys contact lenses are designed for people who live or work in dry environments, travel frequently, sit in front of computers for long periods of time, or are exposed to heated or air-conditioned environments each day. In clinical studies with more than 190 contact lens wearers, those who wore Acuvue Oasys said their vision was consistently crisp and their eyes remained moist, even in challenging environments. And 75 percent said they didn't need rewetting drops. Check with your eye care practitioner to see if these new lenses are right for your eyes.

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CIBA Vision Introduces Focus Dailies with AquaRelease

ATLANTA, December 15, 2005 — CIBA Vision introduced the new Focus Dailies one-day disposable contact lens that offers a built-in moisturizing agent, AquaRelease, to improve end-of-day comfort.

The AquaRelease is dispensed into the wearer's tear film with each blink, which helps maintain the tear breakup time for comfort throughout the day. AquaRelease are available in the same parameter range as the original Focus Dailies and do not require a re-fit. They are made of the same material as the original Focus Dailies, with nearly 70 percent water content. The lenses, like the original Focus Dailies, are non-ionic, which have been reported to lessen protein build-up. Now they also feature a light blue handling tint, so they're easier to see when you insert and remove them.

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New Hybrid Contact Lenses from SynergEyes
Available Nationwide in Mid-2006

CARLSBAD, Calif., December 15, 2005 — Three new hybrid lenses featuring both a rigid gas permeable center and a soft, hydrophilic outer skirt by SynergEyes received FDA market clearance and will be available to consumers by mid-2006.

The new hybrid contacts include the SynergEyes A lens for ametropia — targeting patients with astigmatism and current gas permeable lens wearers — the SynergEyes KC lens for keratoconus and the SynergEyes M lens for presbyopia. SynergEyes A will have a national rollout in mid-2006. SynergEyes KC is targeted for introduction in May 2006, and SynergEyes M, a multifocal design, is anticipated for release in 2007.

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FDA Clears Alcon's Disinfection Solution for Silicone Hydrogel Lenses

FORT WORTH, December 15, 2005 — The FDA cleared Alcon's OPTI-Free RepleniSH Multi-Purpose Disinfection Solution for all contact lenses, including silicone hydrogel lenses.

The company states this solution will keep both silicone hydrogel and traditional hydrogel lens surfaces fresh and moist throughout the day.

OPTI-FREE RepleniSH contains TearGlyde, a proprietary reconditioning system, that works with the patient's tear components to retain lens surface moisture.

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CooperVision Launches New PC Hydrogel Lens

FAIRPORT, N.Y., December 15, 2005 — CooperVision introduced a new contact lens, the PC Hydrogel, which the company states is more comfortable than other silicone hydrogel lenses currently available on the market.

PC Hydrogels are available in five lens designs, including Proclear Sphere, Proclear Toric, Proclear Multifocal, Ultra Vue PC Multifocals and the new Biomedics XC contact lens. Biomedics XC is the first PC Hydrogel lens to be offered in a two-week modality. This lens will be available mid-January 2006.

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Extended Wear Silicone Hydrogel Contacts Pose Minimal Risk of Infection

BALTIMORE., December 7, 2005 — Corneal infections are not more common in people who wear 30-day silicone hydrogel lenses, researchers from the Johns Hopkins Wilmer Eye Institute reported. The study, which was published in Ophthalmology, found that the risk of infection in the extended wear contacts was comparable to that of older lens types worn for fewer nights.

All participants in the study were prescribed and fitted with CIBA Vision NIGHT & DAY silicone hydrogel soft contact lenses to be worn for 30 consecutive 24-hour periods. Overall, the yearly rate of corneal infections was 18 per 10,000 people, the study found. This is similar to rates reported for conventional, extended-wear soft lenses worn for fewer consecutive nights.

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Contacts with Selenium Coating Begin Clinical Trials

AUSTIN, November 2005 — The Institute for Eye Research at the University of New South Wales announced it will begin laboratory and clinical testing of antimicrobial contact lenses with selenium coating.

Researchers will attempt to demonstrate that lenses coated with selenium stop the normal buildup of bacteria, film and deposits on the lenses, which will in turn eliminate potential adverse reactions, risk of infection and discomfort for the lens wearer.

More than 250 patients are expected to participate in the clinical trials, which will test daily wear and extended wear lenses.

The selenium technology was developed by doctors at the Texas Tech University Health Sciences Center in Lubbock, Texas. The Institute will collaborate with Selenium Ltd. for the clinical tests.

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New Law Lets FDA Reclassify Cosmetic Contact Lenses
as Medical Devices

WASHINGTON, D.C., November 9, 2005 — Wearing contact lenses that don't fit properly can cause corneal ulcers, infections, eye injury, and even loss of vision. Therefore the FDA has long classified contacts as medical devices, so it could bring legal action against those who sell them without requiring a prescription or fitting from an eye care professional.

"Decorative" contact lenses — worn to change the way the eyes look but without providing any vision correction — were exempt from such FDA oversight for the past two and a half years because during that time they were classified as cosmetic items.

A bill (H.R. 371) was introduced in the House in January to reclassify decorative contact lenses as medical devices; it passed on October 26. A similar bill (S. 172) was passed in the Senate in July. And today President Bush signed the bills into law.

Eye care professionals and others see the new law as a big step toward protecting the eyes of teens and young adults, because it lets the FDA take action against contact lens retailers who don't follow the agency's rules for selling medical devices.

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PureVision Contact Lenses Are Back in the USA —
and Now Are FDA-Approved for Astigmatism

ROCHESTER, N.Y., May 2005 — PureVision silicone hydrogel contact lenses were released in the United State a couple of years ago, but manufacturer Bausch & Lomb discontinued them here because of a patent dispute. That's resolved now, so PureVision is back, just as soon as eye care practitioners across the nation receive their sets of fitting lenses. These are Bausch & Lomb's contacts that can be worn for up to 30 days straight, including overnight, depending on your eye care practitioner's recommendation. PureVision is one of only two contact lens brands that have FDA approval for 30 days and nights of wear. The combination of lens geometry and silicone hydrogel provides exceptional health and comfort for contact lens wearers, according to Bausch & Lomb.

Also the FDA has approved PureVision Toric contact lenses for myopia and hyperopia with up to -5.00 diopters of astigmatism. PureVision Toric is already available in overseas markets but will be launched in the United States this summer. Read more about toric contact lenses and extended wear contacts.

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For People Over 40 with Astigmatism: CIBASOFT Progressive Toric

ATLANTA, April 2005 — This contact lens has a toric design to correct astigmatism and a multifocal configuration to offer excellent intermediate and near vision without compromising distance acuity, according to CIBA Vision. It's meant for people with presbyopia, a condition that starts at around age 40 and worsens as we get older.

During the test market phase, 81 percent of wearers achieved 20/25 or better distance acuity, and 75 percent achieved 20/30 or better near acuity with the first lens tried. In the United States, presbyopes with 0.75 diopters of astigmatism or greater account for 30 percent of the vision correction population, which is about half of the overall population. Check with your eye care practitioner to see if you're a candidate.

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This New Contact Lens for Astigmatism from Acuvue Is
Designed for Crisper Vision Even When You Blink

JACKSONVILLE, Fla., March 2005 — Acuvue calls it the biggest technology breakthrough for toric contact lenses in 15 years: the accelerated stabilization design of Acuvue Advance Brand Contact Lenses for Astigmatism.

To correct astigmatism effectively, toric contact lenses must rest on the eye at a certain position. The problem is, when you blink, the lens tends to rotate a little, so vision is blurred or fluctuating. But Acuvue Advance toric contact lenses are designed to work with the blink, not against it, for continuous stability all day. In clinical trials, 82 percent of wearers rated Acuvue Advance "very good to excellent" in not moving in and out of place, vs. 56 percent for another leading toric lens.

Also, Acuvue Advance Brand Contact Lenses for Astigmatism are the first toric lenses with Hydraclear, a combination of an oxygen-rich material and a moisture-rich wetting agent, for a silky, comfortable feel on the eye. Please click here for a diagram that compares the accelerated stabilization design with the design of other toric contact lenses.

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Novelens Case Separates Your Contact Lenses from Dirty Deposits

FAIR LAWN, N.J., December 2004 — Poor contact lens care causes eye discomfort, redness, and even serious complications such as infectious keratitis. Often the cause is a dirty lens case. But now, Novelens comes to the rescue with a new type of lens case that has two chambers: one above, which holds the contact lens, and one below, into which deposits from the upper chamber are drained with the disinfecting solution.

The lens is held above the deposits all night, so it won't be recontaminated by them. The next morning, you just discard the spent cleaning solution. The case is designed to be used with all soft contact lenses and with any of the multi-purpose solutions. Novelens believes its new product will become the contact lens case of choice. It's available online or from eye care practitioners. Click here for a diagram of how the Novelens case works.

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Focus Dailies Toric Contacts Now in More Prescriptions
for More People with Astigmatism

ATLANTA, November 2004 — If you have astigmatism and have a high prescription, you may think there's no daily disposable contact lens for you.

But now Focus Dailies Toric lenses come in even more powers than before, so more people with astigmatism can enjoy the convenience, comfort, hygiene, and visual acuity that these daily disposables offer.

Powers now range from +4.00 to -6.00 in quarter-diopter steps, as well as -6.50 to -8.00 in half-diopter steps. Focus Dailies Toric contacts also come in plano, for astigmats who don't need a spherical power in their lens.

Questions? Ask your optometrist, ophthalmologist, or other eye care professional about Focus Dailies Torics. Read more about toric contact lenses.

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New Hand Soap for Contact Lens Wearers

SAN JOSE, Calif., October 2004 — Here's a liquid hand soap especially for people who insert and remove their contact lenses every day. Optimum by Lobob Contact Lens Wearers Hand Soap is antibacterial, biodegradable, unscented, and hypo-allergenic.

It also contains no animal ingredients, artificial colorings, irritating oils, or perfumes. Eyecare practitioners recommend thorough hand-washing before you insert or remove your lenses, and this hand soap contains 22 percent glycerine, to keep hands soft even with frequent cleansing.

Optimum by Lobob Contact Lens Wearers Hand Soap comes in 12-oz. pump dispensers and is available through eyecare practitioners or other retailers, both in stores and online. Please click here for sources.

What's New in Contact lenses continued...

[Page updated May 2007]