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Sunday, January 9, 2011  
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Care Solution Corner
Susan J. Gromacki, OD, MS, FAAO

Since this is my first column of the new year, I thought it would be a good time to reflect back on last year. There was much good news regarding contact lens care in 2010, with more expected in 2011. I will review some of the things I am thankful for--in no particular order--and offer some new year's resolutions.

I am thankful for the plethora of new research publications in the areas of contact lens care. I resolve to stay even more current with the literature than I did last year. I am thankful for the lens care industry's commitment to research and product development (millions of dollars annually). I am thankful for two new products in 2010 (Biotrue, Bausch + Lomb and RevitaLens OcuTec, Abbott Medical Optics), and look forward to further potential introductions this coming year. I resolve to always offer my patients the most up-to-date technology, and that includes new solutions. I am thankful for the United States Food and Drug Administration, which has been working diligently to ensure the safety and efficacy of care systems. I resolve to be more patient with their process of determining new guidance recommendations regarding the testing of multipurpose contact lens care products.

Stay tuned in 2011; it's going to be another fun year! Happy New Year, everyone!

Ocular Surface Update
Kelly K. Nichols, OD, MPH, PhD, FAAO

Clinicians managing dry eye try to simplify the diagnostic process by selecting tests that are easy to perform in clinical practice. Additionally, clinicians often rely on dry eye symptoms, in making a diagnosis as well as in monitoring change with a treatment or progression if untreated. Clinicians and patients alike prefer clinical tests that provide a "number" to track how a patient is responding to therapy as in monitoring other conditions such as blood pressure or intraocular pressure. However, in dry eye management, there has not been a single test that provides a "number," until recently, with the measurement of tear osmolarity.

The TearLab Osmolarity System (TearLab Corporation, San Diego, CA) is a diagnostic instrument that has recently gained a lot of press as a quick, easy-to-use objective dry eye diagnostic test. The in-office, hand-held instrument can measure osmolarity noninvasively in about 10 to 20 seconds. Several studies have assessed the diagnostic ability of osmolarity in dry eye with this new lab-on-chip technology (1-3), and additional studies to assess the ability of osmolarity to respond to changes with treatment are ongoing. It will take time to fully understand how this tear measure changes with time or treatment, but for now, it is an innovative addition to the dry eye armamentarium.

References:
1. Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30

2. Versura P, Profazio V, Campos EC. Performance of tear osmolarity compared to previous diagnostic tests for dry eye diseases. Curr Eye Res. 2010 Jul;35(7):553-64.

3. Tomlinson A, McCann LC, Pearce EI. Comparison of human tear film osmolarity measured by electrical impedance and freezing point depression techniques. Cornea. 2010 Sep;29(9):1036-41.

NEWS
CIBA Vision Reaches Global Settlement Agreement with J&J Vision Care

Novartis announced that CIBA Vision has reached a global settlement agreement with Johnson & Johnson Vision Care, Inc. to license the CIBA Vision "Nicolson" patents, which protect its proprietary silicone hydrogel contact lens technology. The settlement ends ongoing litigation in the U.S., as well as several European countries.

As indicated by Novartis, the settlement covers the Johnson & Johnson Vision Care full portfolio of silicone hydrogel contact lenses, including Acuvue Oasys, Acuvue Advance and 1-Day Acuvue TruEye. It allows J&J to continue to manufacture, market and sell its silicone hydrogel contact lenses on a worldwide basis under a license from CIBA Vision, including markets previously under court-ordered injunction. The terms of the agreement, including financial details, are confidential.

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Voluntary Recall of Soothe Xtra Hydration (XH) Eye Drops

Bausch + Lomb (B+L) is conducting a voluntary recall of its Soothe Xtra Hydration (XH) eye drops, only available within the United States.

According to the company, B+L chose to initiate this recall based on a small number of consumer reports citing the presence of possible foreign matter in the tip of the bottles. Initial testing by B+L on the opened, partially-used product has identified the particles as mold.

While there have been no adverse events reported for this product in connection to mold, B+L has chosen to voluntarily recall all existing lots of the Soothe Xtra Hydration (XH) eye drops in the interest of patient safety. After the bottle is opened, eye drops which may become contaminated may also cause eye infections, as such the Company is taking this voluntary action to protect consumers.

B+L has alerted the U.S. Food and Drug Administration of this voluntary recall. The Company is asking consumers who currently have Soothe Xtra Hydration (XH) eye drops to return the product to B+L. Even if consumers are comfortable using the eye drops, they are urged to return the product. Consumers who have this product in their home should call one of the following numbers for instructions on returns and reimbursement: Soothe Xtra Hydration (XH) Recall Hotline: 1-877-907-9964 or B+L customer service center: 1-800-553-5340.

B+L is conducting an ongoing investigation. A determination of future product distribution will be made at the close of this investigation which could last several months.

The Soothe Xtra Hydration (XH) eye drops are the only eye drops affected in this recall; all other Soothe eye products remain on the market.

Conway and Polonyi Join Contamac

Contamac announced that Martin Conway, FBDO has joined their Professional Services team. Conway has over 25 years experience in the eye care industry, in his own optician practices and representing Revlon, Sauflon Pharmaceuticals and Ciba Vision. His wealth of experience and expertise will help the company expand its professional and clinical support to its customers, as well as support their Research and Development team at a clinical and professional level.

The company also announced the appointment of Philipp Polonyi to its Sales and Marketing team as Sales Executive focusing on the Central European market. Originally from Giengen an der Brenz in the South of Germany, Polonyi moved to the UK three years ago. Polonyi extensive industry and clinical knowledge will be a valuable asset. His previous role at A.T. Cross was as Customer Service Manager covering multiple European markets.

CooperVision Awards an Additional $25,000 in Grant Funding to Help Teen Athletes Excel in Sports

CooperVision announced the second round of winners of $25,000 in Gear Up Grant funding. The program was established earlier this year as part of the company's Contact Sports initiative, which continues to help young athletes and teams across North America get the athletic equipment they need to succeed, while promoting the importance of eye health.

The ten winners of the second round of Gear Up Grants are: AL Stanback Girls Volleyball Team, Hillsborough, NC; Club Olympia Judo, Fond du Lac, WI; Crested Butte Junior Nordic Ski Team, Crested Butte, CO; Grandview High School Swim Team, Columbus, OH; Glades Day School Football Team, Belle Glade, FL; La Porte Midget Cheer Team, LaPorte, IN; Millennium High School Baseball Team, Tracy, CA; Renaissance Magnet High School Weightlifting Program for Self-Esteem, Meridian, ID; Rock Hill High School Boys Basketball Team, Catawba, SC and Whitewater Alberta Slalom Canoe/Kayak Team, Calgary, AB, Canada.

The winning teams will each receive $2,500 in grant funds and each athlete on the team who needs corrective lenses will receive a one year supply of CooperVision contact lenses.

Still Time Register for the Global Specialty Lens Symposium, January 27-30, 2011, Paris Hotel & Casino in Las Vegas

The 2011 Global Specialty Lens Symposium is rapidly approaching, but there is still time to register! With an expert international faculty and a CE-accredited agenda, the 2011 GSLS will include insightful presentations by experts in the field, hands-on demonstrations of cutting-edge products as well as scientific papers and posters. Look for more detailed information in Contact Lens Spectrum and online at www.GSLSymposium.com, where you may also register.
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Wolters Kluwer Pharma Solutions VisionCare Group Recognized by Optometry Giving Sight as Gold In-Kind National Sponsor

Optometry Giving Sight is pleased to recognize Wolters Kluwer Pharma Solutions VisionCare Group as Gold In-Kind National Sponsor. Wolters Kluwer Pharma Solutions VisionCare Group has been a supporter of the vision charity for many years by providing in-kind ad and advertorial space in their publications Eyecare Business, Optometric Management and Contact Lens Spectrum.

"We are so grateful to enter into a formal arrangement with Wolters Kluwer Pharma Solutions VisionCare Group as Gold In-Kind National sponsor. The company has supported us for so long and we are thankful for their efforts in helping us bring much needed vision care and glasses to people in developing countries," said Vic Connors, OD, CEO of Optometry Giving Sight, USA.

BCLA 2011 Program Announced and Registration Open

With the announcement of the Clinical Conference scientific program this month, plans are well underway for BCLA 2011, what the British Contact Lens Association believes will be a truly valuable event for all delegates — whatever their level of skill and expertise in the field of contact lenses and the anterior eye.

Taking place in the newly refurbished Manchester Central Convention May 26-29, BCLA 2011 is themed: Learn Today — Practice Tomorrow. The event will offer a host of new features and a wide range of learning and hands-on events.

This year's keynote speakers are:

  • BCLA Medalist, Professor Mark Willcox (Australia)
  • Irving Fatt Memorial Lecturer, Dr. Jacinto Santodomingo (Spain)
  • Professor William Ayliffe (UK)
  • Professor Joe Bonnano (USA)
  • Dr. Kathy Dumbleton (Canada)
  • Dr. Lisa Keay (Australia)

As always, the free BCLA Exhibition will be at the heart of proceedings. A new feature for 2011 is an exhibition pavilion where exhibitors can run short sessions over the full three days. And, this year's Gala Dinner will have a Bollywood theme with echoes of the Indian Raj.

Visit www.bcla.org.uk for details and to register. You may also contact the BCLA office at conf@bcla.org.uk.



This month at www.siliconehydrogels.org: Children and contact lenses, myopia progression, use of silicone hydrogels for patients with epidermolysis bullosa, and our synopsis of silicone hydrogels at the 2009 ARVO meeting.
Editor's Commentary
Jason J. Nichols, OD, MPH, PhD, FAAO

As noted in the poll results this week, the vast majority of you believe that daily disposables are associated with a reduction in the risk in microbial keratitis (about 84% of those responding believe this to be true). This is interesting in that it contradicts at least one study (Dart, Ophthalmology, 2008) that showed an increased risk for microbial keratitis, particularly with specific daily disposable brands. What is clear to me is that we certainly need more research on this controversial topic to help clarify this issue.

Dart JK, Radford CF, Minassian D, Verma S, Stapleton F. Risk factors for microbial keratitis with contemporary contact lenses: a case-control study. Ophthalmology 2008 Oct;115:1647-54.

CLToday Quick Poll

Last week's question:
Are daily disposables generally associated with a reduction in the risk of microbial keratitis?

 Yes
   84%

 No
   16%

Abstract
Impact of Multipurpose Solutions Released from Contact Lenses on Corneal Cells

The purpose of this study was to assess, in vitro, the effect of the release of contact lens multipurpose solutions (MPS) from two silicone hydrogel lenses on human corneal epithelial cells.

A monolayer of immortalized human corneal epithelial cells was seeded in a 24-well plate in keratinocyte serum-free medium. Lotrafilcon A (LA) and balafilcon A (BA) lenses were placed on top of the adherent cells for 8 and 24 hours, after being soaked in MPS, borate-buffered (Unisol) or phosphate-buffered saline overnight. Cells were assayed for viability using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay or for alpha3, beta1, and beta4 integrin expression and caspase activation by flow cytometry.

After 8 hours, LA lenses soaked in Unisol, Opti-Free Express (OFX), and ReNu MultiPlus (ReNu) showed decrease in cell viability. LA and BA soaked in Complete Moisture Plus (Complete) had similar viability at around 85% of control. After 24 hours, a further decrease in viability was observed with all MPS-soaked lenses; LA soaked in OFX significantly reduced viability compared with Unisol-soaked lenses. In addition, reduced levels of integrin expression for lenses soaked in OFX and ReNu, and for BA soaked in Complete were observed. At 24 hours, only LA soaked in OFX led to an increase in caspase activation.

The researchers concluded that results indicate an increase in cytotoxicity with borate-based MPS solutions in vitro when compared with both phosphate-buffered saline and borate-exposed lenses, suggesting that biocides and/or additives play a role in the observed cell reaction. Moreover, the mechanism of in vitro solution-induced toxicity appeared to be mediated by lens type, suggesting differences in the preferential adsorption/release profile of certain compounds.

Tanti NC, Jones L, Gorbet MB. Impact of Multipurpose Solutions Released from Contact Lenses on Corneal Cells. Optom Vis Sci. 2010.


Important Links:
To report adverse contact lens reactions visit: http://www.accessdata.fda.gov/scripts/medwatch/ or call (800) FDA-1088.
To report possible grievances related to the Fairness to Contact Lens Consumers Act or associated Contact Lens Rule visit: 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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