CONTACT LENSES TODAY
August 7, 2005
Contact Lenses Today® is edited by Dr. Joseph T. Barr and the staff of Contact Lens Spectrum. This week CLToday® reaches more
than 10,000 readers in 74 countries.
Cosmetic Contact Lenses are Medical Devices
On July 29th, the U.S. Senate unanimously approved bill S. 172 that amends the Federal Food, Drug and Cosmetic Act to stipulate that all
contact lenses are medical devices. With this addition, the Act now applies to cosmetic lenses as well as corrective lenses. Representative John Boozman, O.D., served as
the bill’s prime sponsor.
Since 2003, the FDA has issued warnings to consumers and acknowledged receipt of reports on corneal ulcers associated with decorative contact
lenses. A companion bill (H.R. 371) is pending before the House of Representatives.
ABB Acquires Wise Optical
ABB Optical announced the acquisition of Wise Optical’s contact lens business. The combined company will be the largest contact lens
distributor in the U.S. ABB says the acquisition will enable the company to further upgrade its order-processing automation, broaden internet access and expand its
inventory.
J&J to Adopt Direct-to-Consumer Guidelines
Johnson & Johnson’s pharmaceutical businesses have adopted the pharmaceutical industry’s Guiding Principles on Direct-to-Consumer (DTC)
advertising. The Pharmaceutical Research and Manufacturers of America (PhRMA) approved the guidelines on July 19. They will go into effect in January, 2006. The
principles exceed what is mandated by regulation and include the following points:
• Companies should spend an appropriate amount of time educating health care
professionals before DTC advertising.
• All new DTC advertising should be submitted to the FDA before being released for broadcast.
• DTC must be targeted
at appropriate age groups.
• Companies should no longer use reminder ads, which identify the product name, but not the indications or major risks
associated.
• DTC should be a balanced presentation of benefits and risks.
VISTAKON® has begun airing national TV advertising in support of their exciting new contact lens, ACUVUE® ADVANCE™ Brand
Contact Lenses for ASTIGMATISM, and to help increase patient visits.
One advertisement — titled “Twins” — targets a younger audience and is geared towards first time contact lens wearers with astigmatism.
The other — “A Day in the Life” — was created to appeal to a broader, more mature audience, including current toric wearers and dropouts. The commercials are to air on
stations such as FOX, WB, MTV, and USA. Tune in!
--ADVERTISING
Menicon Launches New Care Products
Menicon now offers a complete line of contact lens care products, with the launch of MeniCare Soft and MeniTears this June at the British
Contact Lens Association annual conference. MeniCare Soft with Comfortec is a polyhexanide-based multipurpose solution. It provides a high spectrum of antimicrobial
activity, low toxicity and excellent comfort for all soft contact lenses. MeniTears, manufactured by Advanced Vision Research, is a preservative-free lubricant eye drop,
packaged in single doses. Its’ patented hypotonic formula is approved for all soft, GP and silicone hydrogel contact lenses. Both products will soon be available in the
U.S.
Growth in Silicone Hydrogel Market
Health Products Research, a company that audits eye care professional dispensing of contact lenses, released data that indicated silicone
hydrogel lenses accounted for 29% of new soft lens fits in the U.S. in the first quarter of 2005 compared with 17% last year.
Abstract:
Refractive and Biometric Changes with Silicone Hydrogels
British researchers conducted an 18-month longitudinal study of the changes in refraction and biometry in new daily wear and continuous
wear patients in two different silicone hydrogel materials. Fort-five subjects were assigned to wear either Lotrafilcon-A or Balaflcon-A lenses on either a continuous
or daily wear schedule. Doctors measured refraction, axial length, anterior chamber depth, corneal curvature and the rate of peripheral corneal flattening at 1, 3, 6,
12 and 18 months after the initial fitting. Refractive error increased in the myopic direction in all wearers, but patients in the Lotrafilcon-A group showed a slightly
greater mean increase in myopia. Investigators conclude that increases in myopia still occur with silicone hydrogel contact lens wear. They also note that differences
between these results and those of other studies could be due to the differing populations studied, in which both age and occupation may play a
role.
Doughty MJ, Aakre BM, Ystenaes AE, Svarverud E. Short-term adaption of the human corneal endothelium to continuous wear of silicone hydrogel
(lotrafilcon-A) contact lenses after daily hydrogel lens wear. Optom Vis Sci. 2005 Jun;82(6):473-80.
Editor's Commentary:
Cosmetic Plano Lenses will be Safer
The unanimous U.S. Senate approval of S. 172 that amends the Federal Food, Drug and Cosmetic Act to stipulate that all contact lenses
are medical devices is an important breakthrough. This is a great step toward preventing unauthorized sale of plano cosmetic lenses, which is an important public
health issue. Kudos to Representative John Boozman, O.D., the bill’s primary sponsor, and to Tim Steineman, M.D., of Cleveland, for being an outspoken supporter of
this effort. See the May 22 issue of CLToday for my comments on Dr. Steineman's efforts.
Fitting Tip:
Cleansing Compliance
Clean hands are important when handling contacts, even more so now with silicone-hydrogel lenses, which have a tendency to bind lanolin
and similar lipids and oils. Almost all hand soaps have some kind of moisturizer, which is left as residue on the hands. Mixing one part antibacterial dish detergent
with two parts water in an empty pump dispenser yields an excellent hand soap that leaves no residue and costs about $1.50 for a half a gallon. Interestingly, if you
read the label the fine print says, "Antibacterial Hand Soap."
-- Daniel P. Roy, O.D.
Sanford, Maine
This month at www.siliconehydrogels.org http://www.siliconehydrogels.org, review the daily wear performance of silicone
hydrogels; read the results of contact angle analysis of lens wettability; and scan a synopsis of silicone hydrogels research at ARVO 2005.
Report adverse contact lens reactions here: http://www.accessdata.fda.gov/scripts/medwatch/ or
call (800) FDA-1088.
Access a reporting form for complications you've seen that were a result of contact lenses dispensed without a valid
prescription at the Association of Regulatory Boards of Optometry's (ARBO's) Web
site: http://www.arbo.org/arbo.asp?dt=R&doc=Complications. Complete and send the form online or print
it out and fax it to (866) 886-6164.
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