Sunday, February 1, 2009 A free weekly e-mail newsletter brought to you by: 
CLToday Contact Lens Spectrum
Edited by Jason J. Nichols, OD, MPH, PhD, FAAO and the staff of Contact Lens Spectrum
This week CLToday® reaches more than 14,000 readers in 74 countries. 
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AOA Representatives and Other Industry Leaders Meet with FDA to Discuss Contact Lens Care Products

In an effort to increase the safety and effectiveness of contact lenses and lens care products for consumers, on January 22-23 the American Optometric Association (AOA) cosponsored a workshop with the U.S. Food and Drug Administration's Center for Devices and Radiological Health (FDA/CDRH) and other ophthalmic leaders. In addition to the AOA and the FDA, sponsors included the American Academy of Ophthalmology, the American Academy of Optometry and the Contact Lens Association of Ophthalmologists. AOA representatives Dr. William Benjamin and Dr. Christine Sindt emphasized the importance of stricter standards for contact lens solutions, including changes in current no-rub policies, premarket testing of products, and changes in labeling of products.
     To help protect consumers from infections and other complications, the AOA and other leaders in the vision care community have been urging the agency to expand current testing practices for contact lens care products to include Acanthamoeba. Participants also discussed improving microbiological test methods to better simulate "real world" consumer use conditions, including patient non-compliance.
    In a follow-up press release the AOA reports that during the workshop participants reached consensus on testing parameters and new criteria for disinfection efficacy test methods. Specifically, the working group found agreement on the particular Acanthamoeba parasite species and strains to test as well as an acceptable threshold for disinfection efficacy. The FDA has announced that it will release the results of the workshop on the FDA Center for Devices and Radiological Health website.

Paragon's High Refractive Index Material Receives FDA Clearance

Paragon Vision Sciences announced the immediate availability of Paragon HDS HI 1.54, a new FDA approved GP contact lens material which, as noted by Paragon, provides the highest refractive index available to eye care practitioners worldwide.
     The high index of this material, combined with its low specific gravity, will provide many useful benefits to contact lens fitters and their patients worldwide, especially when prescribed in aspheric multifocal lens designs, according to the company. Paragon indicates that HDS HI 1.54 could deliver as much as 1.00D of incremental add power, will prove beneficial in increasing optical zone diameters, will reduce overall lens mass associated with high myopic prescriptions and could improve overall GP lens comfort and oxygen transmissibility. 
     "For years contact lens fitters have known they could enhance the effective add power of aspheric lenses through higher-index GP materials. With the growing number of presbyopic patients in need of higher add powers, contact lens fitters and consumers worldwide will immediately benefit from having HDS HI 1.54.  It's clear, as the GP market focuses on specialty modalities like presbyopia, HDS HI 1.54 will enable a practitioner to meet the demands of the growing specialty GP market in an extremely effective manner," said Joe Sicari, President and CEO of Paragon.  
     For additional information about Paragon HDS HI 1.54 contact your Authorized Paragon Laboratory or call 800-528-8279. 

TruForm Introduces DigiForm Semi-Scleral Lenses

TruForm Optics, a custom contact lens manufacturer based in the Dallas-Ft. Worth area, announces the immediate availability of their DigiForm semi-scleral contact lens. "The patent pending DigiForm technology provides the first scleral lens that has specific designs for the five most common irregular corneas," says Jan Svochak, Vice President of TruForm Optics. Per the company, DigiForm technology was scientifically developed so the contact lens will perfectly fit all irregular corneal shapes including those related to keratoconus, post graft, post Lasik, post RK and the eye's natural shape.
     According to TruForm, DigiForm Technology uses Optical Coherence Tomography (OCT) to take a high resolution image of the eye. Digital molds are then made from the images extending well beyond what corneal topographers can measure. Each of these digital molds are placed into a digital library, categorized and then fit to one of the five most common irregular shapes. This digital database allows for the most precise fitting for larger diameter lenses.
     These designs are successfully and simply fit by the eye care practitioner from a 14 lens fitting set. Design options also include: bitoric, quadtoric and multifocal. For additional information contact TruForm Optics at 800-792-1095 or visit www.tfoptics.com.

CLSA Annual Education Meeting Features COPE and NCLE Credits

The Contact Lens Society of America (CLSA) 54th Annual Education Meeting will be held March 18-21, 2009 at the Hyatt Tamaya Resort in Albuquerque, New Mexico. Sixteen hours of COPE-approved contact lens education and 35 hours of NCLE, JCAHPO and ParaO education will be available. Optometrists and opticians from Florida may also receive credit at the CLSA meeting. All CLSA courses have been approved or have approvals pending for CE credits. 
     Noted speakers include: Patrick J. Caroline, FCLSA, FAAO, Mark P. Andre, FCLSA, FAAO, Michael A. Ward, FCLSA, FAAO, David Kading, OD, Michael S, Gzik, FCLSA, and Mile Brujic, among many others. General Session and Individual Courses on topics including multifocals, silicone hydrogels, photography, irregular corneas, pediatric fitting, large diameter lenses and keratoconus fitting will be featured. There will also be an exhibit hall with the latest products and technology for your practice. For details visit www.clsa.info or call CLSA at 800-296-9776.

Comfort for Performance

Now is the perfect time to fit more of your patients in ACUVUE® OASYS™ Brand Contact Lenses with HYDRACLEAR® Plus for all-day comfort and Class 1 UV blocking* for great protection against UV rays. To learn more about our innovations in comfort, vision and health, go to:
*Product and UV Information   
 Important Safety Information
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Sirion Therapeutics NDA for Ganciclovir Accepted for Review by the FDA

Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced that its New Drug Application (NDA) for ganciclovir ophthalmic gel, 0.15%, has been accepted for review by the U.S. Food and Drug Administration (FDA). Sirion Therapeutics is seeking approval for ganciclovir as a treatment for herpetic keratitis, an ocular disease caused by the herpes simplex virus. The FDA has issued an action date in late fall of 2009, under the Prescription Drug User Fee Act.
     "Herpes simplex keratitis remains one of the leading causes of corneal blindness and corneal transplants in the United States," explained Barry Butler, CEO of Sirion Therapeutics. "If approved by the FDA, ganciclovir ophthalmic gel would become the first topical ophthalmic antiviral treatment launched in the U.S. in almost three decades. This product would provide a significant new option for physicians in the treatment of patients with herpetic keratitis."
     To assess the efficacy and safety of ganciclovir, four randomized, multicenter trials compared ganciclovir gel, 0.15%, with acyclovir ointment, 3%, both of which are used as first-line therapies outside the U.S. to treat herpetic keratitis. According to the company, the studies found that ganciclovir is as effective as acyclovir and that the tolerability of ganciclovir was superior to acyclovir, particularly with regard to blurring and stinging or burning sensations after instillation. Additionally, since ganciclovir is formulated as an aqueous gel, it allows for prolonged contact time with the corneal surface.

Alcon on Fortune's "100 Best Companies to Work For" List for 11th Year

Alcon, Inc. announced that for the 11th consecutive year, the company's U.S. affiliate, Alcon Laboratories, Inc., was named to Fortune magazine's "100 Best Companies to Work For" list, placing 74th. "Here at Alcon, we all genuinely care about the work we are doing to preserve, restore and enhance sight," said Cary Rayment, Chairman, President, and Chief Executive Officer. "With the importance of the work, comes an employee enthusiasm that translates to a positive corporate culture."
     With more than half of its U.S. based employees located at its U.S. headquarters in Fort Worth and manufacturing facility in Houston, Fortune noted Alcon's "Texas-friendly" culture as a particularly positive aspect of the company. "To be placed on this list for 11 years now is really an honor that we attribute to our great employees who create such a positive work culture," said Kay Cox, Alcon's Vice President of Human Resources.
     Companies are selected for the "Best Companies" list primarily on the basis of their employees' responses to a 57-question survey that measures items such as job satisfaction and camaraderie, with a smaller portion of the total score based on an evaluation of the company's policies and culture. Companies that are at least seven years old and have 1,000 or more employees are eligible for the list. The full story with the complete list of companies will be in the February 2 issue of Fortune. The list is currently available at www.fortune.com

Contact Lens Spectrum February Case Report Now Online

The Contact Lens Spectrum calendar, which mailed with the November 2008 issue, highlights an interesting and challenging contact lens case each month. The February case report provides Insights into Post Intacs Fitting. To view the details of the case, visit http://www.clspectrum.com/photocalendar.asp?month=February
     Visit the Contact Lens Spectrum case report webpage after the first of every month to review details and images from the latest case study. You can also view case studies from previous months in the archive at the bottom of the webpage.
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Abstract: Visual Comparison of Multifocal Contact Lens to Monovision

The purpose of this study was to compare visual function with the Bausch & Lomb PureVision multifocal contact lens to monovision with PureVision single vision contact lenses. Twenty presbyopic subjects were fitted with either the PureVision multifocal contact lens or monovision with PureVision single vision lenses. After a 1-month trial, the following assessments of visual function were made: (a) distance, intermediate, and near visual acuity (VA); (b) reading ability; (c) distance and near contrast sensitivity function (CSF); (d) near range of clear vision; (e) stereo acuity; and (f) subjective evaluation of near vision ability with a standardized questionnaire. Subjects were then refitted with the alternative correction and the procedure was repeated. All measurements were compared between the two corrections, whereas the "low addition" multifocal lens was also compared with the "high addition" alternative.
     Distance and near VA were significantly better with monovision than with the multifocal option (p < 0.05). Intermediate VA (p = 0.13) was similar with both corrections, whereas there was also no significant difference in distance and near CSF (p = 0.29 on both occasions). Reading speeds (p = 0.48) and the critical print size (p = 0.90) were not significantly different between the two contact lens corrections, but stereo acuity (p < 0.01) and the near range of clear vision (p < 0.05) were significantly better with the multifocal option than with monovision. Subjective assessment of near ability was similar for both types of contact lens (p = 0.52). The high addition multifocal lens produced significantly poorer distance and near CSF, near VA, and critical print size compared with the low addition alternative.
     The authors concluded that monovision performed better than a center-near aspheric simultaneous vision multifocal contact lens of the same material for distance and near VA only. The multifocal option provides better stereo acuity and near range of clear vision, with little differences in CSF, so a better balance of real-world visual function may be achieved due to minimal binocular disruption.
Gupta N, Naroo SA, Wolffsohn JS. Visual Comparison of Multifocal Contact Lens to Monovision. Optom Vis Sci 2009. 

Editor's Commentary: More to Come on FDA Workshop

As was announced late last year and noted in our lead story, the FDA held a workshop entitled "Microbiological Testing for Contact Lens Care Products" January 22-23, 2009. The purpose was to address the many issues surrounding contact lens care that we have encountered these past few years. There was a special focus on preservatives, solution evaporation, compliance, lens rubbing, biofilms, and clinical isolates as challenge organisms. Official transcripts or guidance have yet to be issued, but we will certainly ensure appropriate coverage of this very important topic in the weeks and months to come.
Jason J. Nichols, OD, MPH, PhD, FAAO

This month at www.siliconehydrogels.org: Using silicone hydrogels to mask irregular astigmatism; the relationship between oxygen transmissibility and overnight corneal swelling; and part one of our BCLA 2008 synopsis.

Report adverse contact lens reactions here: http://www.accessdata.fda.gov/scripts/medwatch/ or call (800) FDA-1088.

Report possible grievances related to the Fairness to Contact Lens Consumers Act or associated Contact Lens Rule at: https://www.ftccomplaintassistant.gov/.
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For more information on Contact Lenses Today including archives of previous issues or to subscribe to this newsletter, please visit our website at www.cltoday.com. For the latest articles on contact lenses, important clinical information and helpful tools related to the contact lens practice visit the Contact Lens Spectrum website at www.clspectrum.com.
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