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Sunday, April 27, 2014  
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Results from Last Question

How do you think the majority of contact lenses are distributed to patients in the United States market?

 Direct from the manufacturer
   10%

 Distributor
   51%

 Mass merchandiser
   16%

 Internet supplier
   23%


Editor's Commentary - Jason J. Nichols, OD, MPH, PhD, FAAO
Many sports seasons are heating up right now, or perhaps winding down, with critical playoff games determining victory of prominent teams. The world’s most watched sporting event—the FIFA World Cup—will begin in Brazil this June with an estimated audience of nearly one billion people. How does this relate to contact lenses? I find that practitioners are often unsure how to handle some sports relative to contact lens wear. Many times for certain sports that may involve some physical contact, we suggest the athlete wear soft contact lenses (for fear that a corneal GP lens may dislodge). Likewise, it is generally accepted that reusable contact lenses and swimming (particularly fresh water swimming) are contraindicated. Please look for a full feature article that goes in depth on the issue of sports and contact lens wear in our May issue of Contact Lens Spectrum.


Allergan Receives Unsolicited Proposal from Valeant to Combine Companies
Allergan, Inc. confirmed that it has received an unsolicited proposal from Valeant Pharmaceuticals International, Inc. to acquire all of the outstanding shares of the Allergan for a combination of 0.83 of Valeant common shares and $48.30 in cash per share of Allergan common stock.

According to an Allergan press release, the Allergan Board of Directors, in consultation with its financial and legal advisors, will carefully review and consider the Proposal and pursue the course of action that it believes is in the best interests of the Company's stockholders. The Allergan Board subsequently unanimously adopted a one-year stockholder rights plan effective April 22, 2014 and declared a dividend distribution of one preferred share purchase right on each outstanding share of the Company's common stock. According to the Company, the Plan is not intended to prevent an acquisition of the Company on terms that the Board considers favorable to, and in the best interests of, all stockholders. Rather, the Plan aims to provide the Board with adequate time to fully assess any proposal. (For further details, see http://agn.client.shareholder.com/releasedetail.cfm?ReleaseID=841822)

Valeant’s announcement of the proposal provided details including the support of the proposed merger by Pershing Square Capital Management, L.P., a SEC-registered investment advisor based in New York City, which, as of the announcement, was Allergan's largest shareholder with a 9.7% stake in Allergan. Pershing Square has agreed to elect only stock consideration in the transaction and intends to remain a significant long-term shareholder of the combined company, should the merger proceed.

The Valeant press release also included an open letter from J. Michael Pearson, Chairman and CEO of Valeant to David Pyott, Chairman and CEO of Allergan, detailing Valeant’s position on the advantages and synergies of the proposed merger. Valeant also noted that the transaction would not be subject to a financing contingency as Valeant has obtained a debt financing commitment of $15.5 billion from Barclays and RBC Capital Markets. (Details available here http://ir.valeant.com/investor-relations/news-releases/news-release-details/2014/Valeant-Proposes-to-Combine-With-Allergan-for-4830-in-Cash-and-083-Shares-of-Valeant-Stock-for-Each-Allergan-Share/default.aspx)

Valeant acquired Bausch + Lomb in August, 2013.

Alcon Launches eye2eye App
Alcon has introduced eye2eye, a new app for eyecare practitioners (ECPs). The eye2eye app features a convenient contact lens finder that helps ECPs identify Alcon contact lens products for their patients and can also help ECPs successfully fit potential multifocal and toric contact lens wearers in less time.

The eye2eye app gives ECPs tools to maximize fit success in a range of available contact lenses, including Air OptixAqua Multifocal and Air Optix for Astigmatism contact lenses, which use spectacle and contact lens Rx to ensure a proper fit. The eye2eye app walks the ECP through the entire fitting process from start to finish, which saves chair time. Needing only the patient’s most recent spectacle refraction to get started, staff is also able to utilize the app and pull the recommended initial diagnostic lenses to streamline the fitting process even further.

The eye2eye App, which is currently available in the U.S. only, can be found on the Apple App store, Google Play, and at myalcon.com by searching “eye2eye” in the search bar. It operates on Apple, Android and desktop devices.

Johnson & Johnson Vision Care Accepting Research Proposals
Johnson & Johnson Vision Care Inc. (JJVCI) is now accepting research proposals related to meibography and tear film stability with contact lens wear. Specific areas of interest include the following topics:
  • Correlating clinical findings to (i.e. lid wiper epitheliopathy, subjective symptoms, physiology) meibomian gland image analysis and tear film stability
  • Categorizing magnitude of meibomian gland changes to contact lens type or length of wear

Research proposals must be submitted through the JJVCI Investigator Initiated Study (IIS) application process by contacting the Clinical Research Administrator by email at RA-VISUS-IISRequests@its.jnj.com, or by calling 1-904-443-1525. All research proposals must be submitted in English.

For additional information on JJVC’s IIS process and policy, please go to the following link:
http://www.acuvueprofessional.com/investigator-initiated-studies
.

New Packaging and Bottle Enhancements for Alcon’s Clear Care
Patients and customers will soon notice updated packaging and bottle design enhancements when they purchase Clear Care Cleaning and Disinfecting Solution, produced by Alcon. Clear Care Solution is a hydrogen peroxide-based contact lens care product specially-formulated to deeply clean and disinfect contact lenses.

The packaging enhancements include a newly redesigned closure system and an updated bottle design. The new cartons are expected to hit shelves as early as this month.

Specific changes include:

  • Currently, Clear Care Cleaning and Disinfecting Solution is bottled with a white, screw-top cap over a red tip. This will be replaced with a convenient flip-top cap, similar to the closure system of Opti-Free brand of multi-purpose disinfecting solutions produced by Alcon. However, the new flip-top cap will be red to help remind consumers about the potential consequences of misusing hydrogen peroxide eye care products.
  • The size of the bottle will be updated to one that is slightly shorter and wider.
  • To accommodate the updated bottle design, the outside carton dimensions will also change. Despite a change in size, there are no changes to the product, only to the packaging and design.

For more information about Clear Care Solution, visit www.clearcaresolution.com.


Scleral Lens on Traumatized Cornea
Jaime Ibanez, OD, Villavicencio, Columbia


This is a traumatized, irregular cornea and monocular aphakic case in a male teenager. The scleral lens provides a therapeutic, refractive and protective function and it is a safe device that considerably reduces the aniseikonia. This lens was deliberately fitted with over 350 microns central clearance. High enhancement photography filters were used to contrast the cornea-lens interface.

We thank Dr. Ibanez for this image and we welcome photo submissions from our other 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.


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MATERIALS & DESIGNS
David Kading, OD, FAAO
This is the fifth in a series of articles highlighting designs and innovative technology from our industry partners including some of the specialty contact lens laboratories.

Optometrist’s Vision Thrives in New York

In 1969, Dr. Pat Creighton was having trouble finding contact lenses that met his standards. Once the struggles hit a pinnacle, Pat decided he would design and manufacture his own lenses, and not only for his own patients but for his eyecare colleagues. Now 45 years later, Alden Optical, located in Lancaster, New York (just east of Buffalo), is celebrating their continual product expansions. As the company is known for their precision manufacturing and fantastic soft lens designs, it makes it difficult to highlight their lens portfolio in a short column. Their Astera Multifocal Toric incorporates stable vision and multifocal optics developed by Precilens in Europe into custom parameters to address any level of ametropia. Alden has more recently entered into the custom cornea world with the NovaKone lens for keratoconus patients. And of current excitement, Alden is delving into the scleral lens market this year with the introduction of the ZenLens, which has a simplified fitting system.


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RESEARCH REVIEW
S. Barry Eiden, OD, FAAO

Contact Lens “Problem Patients” Are Common – Can Daily Disposable Lens Wear Be the Answer?

Researchers recently looked at the percentage of what was defined as “problematic” contact lens patients from a population of reusable CL wearers. A group of such patients then were re-fit into daily disposable contact lenses and re-evaluated to determine outcomes.1

In phase one of the study, 398 current reusable CL wearers were evaluated for the frequency of: frequent/constant discomfort or dryness, >=2h of uncomfortable wear, >=grade 2 conjunctival hyperemia (0-4), or >=grade 3 corneal staining (0-15). In the second phase of the study, 217 reusable CL wearers classified as problem patients were randomly refit with daily disposable lenses manufactured from one of two materials: etafilcon A (n=96) or nelfilcon A (n=121) and reassessed 1 week later.

Thirty-nine percent (154/398) of subjects had some qualifying criterion for problematic reusable contact lens wear: reduced comfortable wearing time: 20%, dryness: 20%, irritation: 5%, corneal staining: 8%, and hyperemia: 7%. After refitting with daily disposable contact lenses, the frequency of reduced comfortable wearing time was decreased from 65% to 51% (P=0.0039), dryness from 60% to 41% (P<0.0001) and corneal staining from 28% to 21% (P=0.04). There was no significant change in the frequency of irritation or hyperemia. Some differences were reportedly noted between the two lens materials.

The researchers concluded that a high percentage of reusable contact lens wearers experience clinically significant signs or symptoms of their current contact lens wear and that daily disposable contact lenses may be an effective way to alleviate some of these issues that are so common in contact
lens wear.

The results from this study add to the outcomes of numerous other studies and reports2-4 that confirm the high frequency of discomfort symptoms found in contact lens wearers. It appears from the results of this study that the use of daily disposable contact lenses can have a significant impact on reducing some of these signs and symptoms. However, we need to look even closer at what is going on to be more effective at maximizing our patient’s contact lens wearing experience.

As noted by the researchers, some differences were noted between the two lens materials used in the daily disposable lens refitting. Each lens material has unique characteristics that can be considered when selecting a daily disposable lens. Additionally other potentially impactful areas must be evaluated and managed such as ocular surface and tear film, the patient’s physical environment, medical health and pharmacologic history, contact lens physical fit and design characteristics and lens wearing hygiene. Such a comprehensive assessment will allow the practitioner to maximize chances for an optimal contact lens wearing experience.

1. Hickson-Curran S, Spyridon M, Hunt C, Young G. The use of daily disposable lenses in problematic reusable contact lens wearers. Cont Lens Anterior Eye. 2014 Apr 4
[Epub ahead of print]
2. Dumbleton K, Caffery B, Dogru M, Hickson-Curran S, Kern J, Kojima T, Morgan PB, Purslow C, Robertson DM, Nelson JD, members of the TFOS International Workshop on Contact Lens Discomfort. The TFOS International Workshop on Contact Lens Discomfort: report of the subcommittee on epidemiology. Invest Ophthalmol Vis Sci. 2013 Oct 18;54(11):TFOS20-36.
3. Richdale K, Sinnott LT, Skadahl E, Nichols JJ. Frequency of and factors associated with contact lens dissatisfaction and discontinuation. Cornea. 2007 Feb, 26(2): 168-74.
4. Riley C, Young G, Chalmers R. Frequency of ocular surface symptoms, signs, and uncomfortable hours of wear in contact lens wearers: the effect of refitting with daily-wear silicone hydrogel lenses. Eye Contact Lens. 2006 Dec, 32(6): 281-6.

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The Effect of Tinted Soft CL Wear on FVA and HOAs

The purpose of this study was to investigate the differences of functional visual acuity (FVA) and high order aberrations (HOAs) in relation to tinted and clear hydrogel soft contact lens (SCL) wear.

A prospective comparative study was performed in 16 eyes of 16 healthy volunteers. Dynamic visual acuity (using a FVA measurement system) and higher-order aberrations (using a wavefront sensor) were compared in subjects wearing two types of soft contact lenses: 1-day Acuvue (Vistakon, Jacksonville, FL) clear and the 1-day Acuvue Define (Vistakon, Jacksonville, FL) tinted lens. The blink rates were recorded during FVA testing. The correlation between the difference of HOAs and differences in FVA values was analyzed.

The mean LogMAR FVA scores with clear and tinted SCLs were 0.07±0.13 and 0.14±0.17 (P<0.05). The mean blink frequencies with clear and tinted SCL wear were 18.4±8.3 and 25.3±4.7blinks/min (P<0.05). Both 3rd-order aberrations and total HOAs showed statistically significant differences between the two types of soft contact lenses for 6mm pupil measurements (P<0.05). A significant positive linear correlation was observed between ΔHOAs and ΔLogMAR FVA for 6mm pupil measurements (R=0.53, P=0.04).

The reserchers concluded that tinted contact lens wear appears to induce a reduction in optical quality. Functional visual acuity measurement is a useful procedure to study the changes of visual performance and quality in tinted contact lens wear.

Watanabe K, Kaido M, Ishida R, Dogru M, Negishi K, Tsubota K. The effect of tinted soft contact lens wear on functional visual acuity and higher-order aberrations. Cont Lens Anterior Eye. 2014 Apr 7. [Epub ahead of print]


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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, 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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