As we noted in a Contact Lenses Today editorial on September 30, 2012 (http://www.cltoday.com/issues/CLToday_093012.htm), the U.S. Food and Drug Administration (FDA) has been active over the last several years in working to develop new guidance regarding contact lenses and care solutions. This week in our Abstract column we point out two upcoming related articles, which are appearing in Eye & Contact Lens in 2012. The articles are publicly available as "Published Ahead of Print" through the journal's website, but note that the articles do not contain abstracts. We will bring more coverage to you on this topic in the next several weeks.
To support its considerable investment in Europe and other local regions, CooperVision, Inc. announced a new president, Mark Harty. Harty has extensive experience as a general manager working in numerous international roles. Most recently, he served as the General Manager, Medical and Surgical Division of United Drug (UK) Holdings Ltd. Harty also held the positions of Vice President & General Manager at Boston Scientific, UK, President of Masimo PLC, UK, and Vice President & General Manager - Global Critical Care, Edwards LifeSciences in the United States.
Mark began his new role effective October 8, 2012 and will work from the CooperVision Delta Park offices located in the United Kingdom.
GP Specialists, custom soft and gas permeable contact lens lab, recently received FDA clearance to begin manufacturing made-to-order customizable soft contact lenses in the Definitive Silicone Hydrogel material.
Under the brand name iSight, GP Specialists offers a complete line of specialized soft lenses that include made-to-order spheres, torics, multifocals, and keratoconus designs.
Definitive is a new generation of silicone hydrogel materials developed by Contamac specifically to give authorized lab partners the ability to manufacturer high Dk specialty soft contact lenses. The Definitive silicone hydrogel material is now available in all GP Specialists made-to-order designs. Call 800 899-0379 or visit their website at www.gpspecialists.com for more information.
Contact lens educators worldwide could soon be adding letters after their names under the International Association of Contact Lens Educators' Fellowship program.
IACLE's Fellowship Exam, held every two years, will next take place in November 2013. Successful candidates can then apply to become Fellows of IACLE and use the affix FIACLE in recognition of their contact lens knowledge.
All IACLE members are eligible to sit the exam but must serve a minimum of 12 months before becoming Fellows. New members who join by 30 November this year will therefore be eligible for Fellowship immediately on successful completion of the exam in November 2013. Since annual membership is normally by calendar year, joining now also provides an extra two months free of charge.
Educator Membership is open to all those involved in contact lens education at a recognized institution, and Associate Membership to individuals and industry representatives contributing to education and active in IACLE. Members gain many valuable benefits from high-quality teaching materials and online resources to regional training meetings and global networking opportunities.
Plan now to attend the Global Specialty Lens Symposium January 24-27, 2013, at the Rio All Suites Hotel and Casino, Las Vegas, Nevada. With an expert international faculty and a CE-accredited agenda, the 2013 GSLS will include a fundamentals pre-conference, insightful presentations by experts in the field, hands-on demonstrations of cutting-edge products, as well as scientific papers and posters and networking opportunities with your colleagues from over 30 different countries.
Look for more detailed information in future issues of Contact Lens Spectrum and online at www.GSLSymposium.com.
The Vision Council was selected as a winner in the 19th annual National Health Information Awards. This program recognizes the nation's best consumer health information programs and materials.
The Kids UV Brochure, which received a Silver Award for Booklet/Brochure/Pamphlet, is a fun activity pamphlet with games, puzzles and stickers, designed to educate children (and their parents) about the dangers of unprotected UV exposure and to promote wearing sunglasses, or other UV-protective eyewear, year-round. This educational resource, is available for free to eyecare providers through The Vision Council's online store at thevisioncouncil.org/ecp.
The Readers Campaign, awarded a Bronze Award for Total Health Information Program, offers a humorous take on the potential pitfalls of not wearing reading glasses. The four-part video series targets males aged 40-55 through a mix of social media and blogger outreach, including placement on AARP's blog. To view the videos, visit youtube.com/thevisioncouncil.
In response to your commentary, we thought it might be helpful to provide a more accurate description of the HyperGel Biotrue ONEday lens material.
As you correctly indicated, many of the first high water hydrogels were based on copolymers of HEMA and NVP (the weight percentage of HEMA in these materials ranged from approximately 30 to 50%). We are sure you also remember how these materials dehydrated on the eye, and led to, in many cases, epithelial desiccation staining.1,2 The on-eye dehydration was so significant that in many cases the lenses would lose up to 15% water over a normal wear period.3 You are also correct in describing HyperGel as fascinating, but we disagree with your characterization of this novel material as a descendant of hilafilcon.
The Biotrue ONEday lens (nesofilcon A) contains 78% water - the same water content as the cornea.4 This HyperGel material meets the oxygen requirements (Dk/t of 42 for -3.00D lens, edge corrected) of the eye for daily wear without the need of adding silicone. The material also possesses a low modulus (50 g/mm2) of elasticity and excellent tear strength, thought to provide good handling characteristics unlike previous high water contact lens designs. The optimum level of cross-linker, strengthening agent and hydrophilic monomer(s) were selected through a series of formulation design experiments. The HyperGel lens material indeed contains a significant amount of the highly hydrophilic monomer NVP, but it contains very little HEMA. In fact, the HEMA is added at a level less than 2 w/w % and is only added per guidelines established by the FDA for a color additive petition.
The other key components of the HyperGel lens material were developed to mimic the natural "surfactant" lipid layer of the tear film, which is responsible for minimizing tear film evaporation in a healthy eye. To best achieve this affect, the surfactants are copolymerized within the Biotrue ONEday lens matrix (they are permanently bound and do not leach out over time) and are enriched at the lens surface at a level 400% that of the bulk material. Based on this innovation, we believe that the desired affect is being realized. During lens wear in a low humidity chamber (5-8% RH), the lens only loses 1.5% water on average following four hours of lens wear. Under ambient wear conditions (approx. 55% RH), the HyperGel lens still loses only 1.5% water even after 16 hours of lens wear.5 In other words, the result is an unprecedented amount of moisture on the eye throughout the day in a contact lens.
Go Bausch! Ring the changes, indeed!
J. Friedrich Künzler, PhD
Director, Department of Polymer Chemistry and Distinguished Research Fellow - Vision Care R&D, Bausch + Lomb Joseph T. Barr, OD MS
Vice President, Global Clinical & Medical Affairs and Professional Services - Vision Care, Bausch + Lomb
1. Orsborn, G.N. and S.G. Zantos. Corneal desiccation staining with thin high water content contact lenses. CLAO J, 1988. 14(2): p. 81-5.
2. Zantos, S.G., et al. Studies on corneal staining with thin hydrogel contact lenses. Journal of the BCLA. 1986. 9: p. 61-64
3. Andrasko, G. The amount and time course of soft contact lens dehydration. J Am Optom Assoc. 1982. 53(3): p. 207.
4. Bergmanson, J.P. Clinical Ocular Anatomy and Physiology-14th Edition. 2007.
5. Schafer, J., et al. Comparing On Eye Dehydration and Corneal Staining of Three Daily Disposable Contact Lenses in a Low Humidity Environment, in British Contact Lens Association 2012: Birmingham, England.
Problem Lens Fit in Keratoconic Patient By Sara N. Gaib, OD, FAAO, Glendale, AZ
This is a photo of the right eye of a 38 year-old male with advanced keratoconus wearing soft contact lenses. He complained of blurry vision and discomfort and reported cosmetic concerns with the appearance of his right contact lens fit. Edge fluting and a large bubble can be noted.
We welcome photo submissions from our readers! It is easy to submit a photo for consideration for publishing in Contact Lenses Today. Simply visit http://www.cltoday.com/upload/upload.aspx to upload your image. Please include an explanation of the photo and your full name, degree or title and city/state/country.
OCULAR SURFACE UPDATE Katherine M. Mastrota, MS, OD, FAAO
Botulinum Toxin and Dry Eye, Part 5 of 5
Part 1 of this series reviewed studies that demonstrated botulinum toxin injection for medical and cosmetic ocular procedures may induce dry eye. How can this finding be used to enhance the study of dry eye?
Recognizing the above fact, Suwan-apichon et al. demonstrated that mouse intralacrimal gland botulinum toxin injection resulted in persistent corneal fluorescein staining and a significant decrease in aqueous tear production in subject mice. Intralacrimal botulinum toxin injection suppressed lacrimation, thereby establishing a murine dry eye state. Of interest, the botulinum toxin injected mouse lacrimal glands revealed no inflammation when histologically examined. This non-autoimmune dry eye model is unique when compared to models in which lacrimal gland inflammation is observed. In this animal model, the localized clinical dry eye state is free from other ocular or systemic side effects. The authors consider that this murine dry eye model could be useful for investigating the pathogenesis of dry eye, preclinical screening of new dry eye therapeutics as well as corneal penetrations of other ocular drugs in ocular surface disease states.
Suwan-apichon O, Rizen M, Rangsin R, Herretes S, Reyes J, Lekhanont K, Chuck R. Botulinum Toxin B-induced mouse model of keratoconjunctivitis sicca. Invest Ophthalmol Vis Sci. 2006 Jan, 47; (1): 133-139
CARE SOLUTION CORNER Susan J. Gromacki, OD, MS, FAAO
The Latest Research in Contact Lens Care and Compliance
One of the best optometric meetings at combining cutting-edge clinical continuing education with the latest ophthalmic research is the Annual Meeting of the American Academy of Optometry. This year, the conference takes place in Phoenix, Arizona, from October 24-27, 2012. Contact lens care and compliance is again a popular topic, with two continuing education courses and at least twenty scientific program posters and papers. The latter includes research on multipurpose solutions, compliance with contact lens replacement and care, scleral lens insertion, Acanthamoeba, Fusarium, corneal infiltrates, and corneal staining.
Prior to the meeting, the Academy posts abstracts of all of its presentations online, whether one is attending the meeting or not. To access them, please go to http://www.aaopt.org/, select "Archives," then the year "2012." For those of you attending the meeting, I look forward to seeing you there!
Background Articles on Developing New Guidance Regarding Contact Lenses and Care Solutions
1. Eydelman MB, Kiang T, Tarver ME, Alexander KY, Hutter JC. Preclinical Research to Aid in the Development of Test Methods for Contact Lenses and Their Care Products. Eye & Contact Lens. 2012.
2. Eydelman MB, Tarver ME, Kiang T, Alexander KY, Hutter JC. The Food and Drug Administration's Role in Establishing and Maintaining Safeguards for Contact Lenses and Contact Lens Care Products. Eye & Contact Lens. 2012.