CONTACT LENSES TODAY

September 15, 2002

Contact Lenses Today® is edited by Dr. Joseph T. Barr and the staff of Contact Lens Spectrum. This week CLToday® reaches 8,829 readers in 74 countries.

The Battle to Stop Cosmetic CL Deregulation Continues
Following our story from last week, Senator Edward M. Kennedy (D-Mass) recently joined forces with Rep. Henry Waxman (D-Los Angeles) and the AOA to convince the FDA to reconsider deregulating cosmetic contact lenses. In his letter, Sen. Kennedy states, "FDA's plan to deregulate colored contact lenses is bad policy and bad law."

Other recent news regarding this situation involves CIBA Vision, which has filed a lawsuit in the U.S. District Court for the Northern District of Georgia in Atlanta against two Georgia companies for the widespread distribution and sale of contact lenses. The suit, filed last week, alleges that the two companies are engaged in the sale and distribution of color contact lenses without prescriptions, without providing instructions for use and without medical advisories required by law. CIBA Vision is seeking permanent injunction, damages and attorney's fees.

Ohio Gets Tough on Illegal CL Sales
Ohio Attorney General Betty Montgomery is cracking down on the black market sale of contact lenses in her state after she heard about a Cleveland teen-ager who almost lost her sight from wearing a pair of black market cosmetic lenses.

A recent undercover sweep identified four businesses that were selling contact lenses without a prescription. The attorney general is seeking injunctions to stop these sales and has informed stores in Ohio that they will be put out of business if they sell contact lenses illegally. Store owners may avoid legal action by signing forms promising not to sell the lenses.

Opti-Free to Boast New Comfort Claims
The FDA approved new comfort claims for Alcon Laboratories' Opti-Free Express MultiPurpose Disinfecting Solution. Some of the claims include: Opti-Free Express MPDS No Rub Lasting Comfort Formula; Comfort That Lasts All Day; Lasting Moisture, Lasting Comfort; Provides Lasting Comfort for All Day Wear, Even for Sensitive Eyes; For Any Contact Lenses Including Silicone Hydrogel Lenses. Additionally, the package inserts for the U.S. starter kits are now written in both English and Spanish.

Be sure your practice is ready for the Halloween season. Crazy lenses are now available in eight fun lens options, including our new Bloodshot lens and the patriotic Stars and Stripes lens. Available in powers from plano to -4.00D, Crazy Lenses are high quality, affordably priced contact lenses that give you the hottest production in an already hot niche market. Contact CooperVision at (800) 341-2020 for more information or visit http://www.crazylens.com to view all lens designs.

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The Shine Optical Group is Born
Dr. Vincent Zuccaro has recently been appointed to president and COO of the Shine Optical Group, a contact lens molding and lathing facility near Taipei. The new company has sales, marketing and distribution centers in Taipei, Italy, Holland and the United Kingdom and the newly established Optical Connection, Inc. will service the Americas.

First U.S. Clinical Trial of Staar Toric Implantable Lens
Staar Surgical Company announced that a surgeon recently implanted its first Toric Implantable Contact Lens in a U.S. clinical study at the end of last month. The patient was severely nearsighted and had significant astigmatism, but at 24 hours post-op, his vision improved to 20/30 -1D. The study will include 125 patients with 1-year follow up.

PureVision Transition Program Correction
Last week in "PureVision Patients Compensated," we incorrectly stated that practitioners had up until the first of this month to participate in the Night & Day transition program. The correct deadline is October 1, 2002. We apologize for any confusion this may have caused.

Editor's Commentary: No Matter What, Keep Educating
As we went to press on Friday, September 13, ABC planned to air a segment about cosmetic contact lenses on its "20/20" television program. To find out more about this segment, visit http://abcnews.go.com/sections/living/dailynews/color_contacts020913.html. In the meantime, we expect word any minute on FDA's downclassification of these lenses. I have rarely, if ever, seen weeks like the last few in this industry with so much discussion about FDA's planned deregulation of cosmetic plano lenses to cosmetic status while the three Os and congressmen screamed for the FDA to maintain Rx classifcation for these medical devices. No matter what happens as we go forward, it is our responsibility to educate our patients and others about the proper use of contact lenses and to report untoward outcomes. Give this address to as many of your colleagues and patients as you can to maximize this education effort: http://www.fda.gov/cdrh/consumer/buycontactqa.html

Fitting Tip: GP Comfort
A study about "The Influence of Voltaren on Ocular Discomfort Associated with Adaption to Rigid Gas Permeable Contact Lenses," by Julie Jackson, RN, OD, FAAO, et al., at the University of Houston College of Optometry found that administering Voltaren for one week qid following the dispensing of GP lenses may facilitate adaptation because of greater comfort.
Editor's Note: Of course all off-label use of products should involve informed consent. This tip from the http://www.clspectrum.com Web site.

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