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Sunday, August 29, 2010  
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Research Review
Loretta B. Szczotka-Flynn, OD, PhD, MS, FAAO

I read with interest Dr. Marguerite McDonald's Reader and Industry Forum in the August 2010 issue of Contact Lens Spectrum. She writes about treating dry eye to improve retention and treatment of contact lens patients. Her theory is to treat dry eye patients aggressively and early to prevent contact lens dropout. In addition to standard dry eye management including cyclosporine 0.05% drops, blepharitis is treated with topical azithromycin to the lid margins. I have used this therapy with some success and wonder what the success rates are of other practitioners and researchers?

There are only a few studies that have been presented on the success of topical azithromycin for the treatment of blepharitis. (See references.) Those studies that are published are small, uncontrolled, open label, pilot studies which have shown that topical application of azithromycin (various doses and regimens) is more effective than mechanical therapy (lid scrubs) alone, and it may be a successful stand-alone therapy. There are several clinical trials underway or near completion which will hopefully provide more definitive results. Stay tuned.

References:
Luchs J. Efficacy of topical azithromycin ophthalmic solution 1% in the treatment of posterior blepharitis. Adv Ther. 2008;25(9):858–870.
Trattler WB, Kuhn KL, Haque R, Zink RC, Sall KN, Luchs J. Topical azithromycin improves blepharitis signs and symptoms. San Francisco, CA: American Society of Cataract and Refractive Surgery; 2009 Apr 3–8.
Touhey D, Shapiro A, Torkildsen G, et al. Efficacy of topical azithromycin ophthalmic solution 1% in the treatment of chronic blepharitis patients. Ft. Lauderdale, FL: Association for Research in Vision and Ophthalmology; 2009 May 3–7.
Haque RM, Torkildsen GL, Brubaker K, et al. Multi-center, open-label study evaluating the efficacy of azithromycin ophthalmic solution 1% on the signs and symptoms of subjects with blepharitis. Cornea. In press.

CLToday Quick Poll

Materials & Designs
Ronald K. Watanabe, OD, FAAO

Dr. Kelly Nichols' Ocular Surface Update in the August 8 edition of Contact Lens Today got me thinking about contact lens patients who present with dry eye complaints. When patients say that their contact lenses feel dry, especially at the end of the day, the immediate instinct may be to refit them into a different material. But is this the best way to approach this problem?

Before changing materials, examine the ocular surface. Lid disease can cause evaporative dry eye and should be treated. An aqueous deficiency can be managed with therapies to increase tear volume. Solution preservative sensitivities can be eliminated with peroxide-based systems. Then, if the patient still has dryness symptoms, a material change may be in order.

When refitting to a new material, there are a few things to consider. If signs of hypoxia are present, upgrade to a silicone hydrogel. If the patient is wearing a high water content material, consider a low water alternative to decrease surface evaporation. If surface deposition is significant, shorten the replacement schedule, perhaps to daily. And lenses with built-in wetting agents should be considered. Assess the ocular surface before making lens material changes to more effectively decrease dryness problems.

NEWS
Inspire Stops Clinical Development of Prolacria and Amends Agreement with Allergan

Inspire Pharmaceuticals, Inc. has entered into an amended licensing, development and marketing agreement with Allergan, Inc., which revises terms related to the Prolacria (diquafosol tetrasodium ophthalmic solution) 2% development program and Inspire's right to receive revenues from Allergan based on net sales of Restasis (cyclosporine ophthalmic emulsion) 0.05% and any other human ophthalmic formulations of cyclosporine owned or controlled by Allergan. This action followed the cessation of clinical development of Prolacria.

According a statement from Adrian Adams, President and CEO of Inspire, "At this time, we are not planning to proceed with clinical development of Prolacria. Our strategy is to create shareholder value by focusing resources on our Azasite franchise and our potentially transformational denufosol tetrasodium for cystic fibrosis program."

Under the amended agreement, which now runs through 2020, Inspire is entitled to receive revenues at one global rate based on net sales of Restasis and any other human ophthalmic formulation of cyclosporine owned or controlled by Allergan, with no requirement to co-promote Restasis. Also, Inspire now has unilateral control over any future Prolacria development and commercialization. In the event Inspire resumes the Prolacria clinical development program and receives regulatory approval for a Prolacria product in a particular country, it will have the option to offer Prolacria commercialization rights to Allergan for such country. If Inspire chooses not to offer Allergan Prolacria commercialization rights with respect to a country, Inspire will receive all the commercialization revenues related to Prolacria in such country and Inspire's rights to receive revenues from Allergan based on net sales of Restasis products in such country will terminate.

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ASCO Announces Optometric Education Diversity Mini-Grant Recipients

Nine schools and colleges of optometry have received diversity mini-grants through the Association of Schools and Colleges of Optometry's (ASCO) 2010 Optometric Education Diversity Mini-Grant Program. This program is supported by Luxottica Retail and The Vision Care Institute, LLC.

The diversity mini-grants are designed to provide seed money for a specific program/project to assist schools/colleges of optometry with their long-term diversity/multicultural efforts. Programs may include, but are not limited to summer bridge programs for undergraduate students, mentoring and guidance programs for first-year optometry students, partnerships with organizations, high schools, community colleges and undergraduate programs to promote optometry as a career among underrepresented groups.

The following schools and colleges of optometry were funded: Illinois College of Optometry – Focus on Your Future Summer Program; Indiana University School of Optometry – Eye Do! Making a Commitment to Optometry; The New England College of Optometry – Optometry Career Program; Pacific University College of Optometry – Pacific University InSight 2010; Pennsylvania College of Optometry at Salus University – Summer Internship Program at The Eye Institute; University of Alabama at Birmingham School of Optometry – Providing Diversity in Optometric Education through Continual Enhancement of Current Programs that Promote Diversity in Optometry; University of California, Berkeley School of Optometry – Berkeley Optometry Opto-Camp; University of Missouri at St. Louis College of Optometry – Eyes on Diversity; and Western University of Health Sciences College of Optometry – Reaching Out to Families and Communities – Opening Eyes to Optometry.

Global Specialty Lens Symposium ... August 31 Deadline for Paper and Poster Submission

The Educational Program Committee of the Global Specialty Lens Symposium invites the submission of abstracts. The symposium will be held January 27-30, 2011 at the Paris Hotel and Casino in Las Vegas, Nevada. Papers and abstracts related to presbyopia, keratoconus, corneal topography, post penetrating keratoplasty or related irregular corneal surface, myopia control, orthokeratology and lens care topics are welcome.

Those interested in submitting can visit www.GSLSymposium.com for more information. Web submissions only. Deadline for submissions is August 31, 2010.
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Biosynthetic Corneas in Clinical Trials

Recent reports from a small Phase 1 clinical trial show promise for use of biosynthetic corneas developed by researchers in Sweden and Canada. The biosynthetic mimics of corneal extracellular matrix were implanted to replace the pathologic anterior cornea of ten patients who had significant vision loss.

The biosynthetic implants remained stably integrated and avascular for 24 months after surgery, without the need for long-term use of the steroid immunosuppression. Corneal reepithelialization occurred in all patients, although a delay in epithelial closure as a result of the overlying retaining sutures led to early, localized implant thinning and fibrosis in some patients. The tear film was restored, and stromal cells were recruited into the implant in all patients. Nerve regeneration was also observed and touch sensitivity was restored, both to an equal or to a greater degree than is seen with human donor tissue.

Vision at 24 months improved from preoperative values in six patients. Reportedly, after the patients were also fit with contact lenses their vision was comparable with that of patients who undergo regular human corneal tissue transplants.

Reference:
P. Fagerholm, N. S. Lagali, K. Merrett, W. B. Jackson, R. Munger, Y. Liu, J. W. Polarek, M. Sφderqvist, M. Griffith, A biosynthetic alternative to human donor tissue for inducing corneal regeneration: 24-month follow-up of a phase 1 clinical study.Sci. Transl. Med. 2, 46ra61 (2010). A Biosynthetic Alternative to Human Donor Tissue for Inducing Corneal Regeneration: 24-Month Follow-Up of a Phase 1 Clinical Study



This month at www.siliconehydrogels.org: the results of the 2009 International Contact Lens Prescribing Survey, the impact of UV-absorbing silicone hydrogel lenses, fitting silicone hydrogels for patients with sub-optimal endothelial cell function, and our synopsis of silicone hydrogels at the 2009 American Academy of Optometry meeting.
Editor's Commentary
Jason J. Nichols, OD, MPH, PhD, FAAO

There are significant changes under way in terms of certain aspects of continuing education in the United States, particularly as it relates to guidelines associated with commercial support. These guidelines are being brought forth by regulatory bodies such as the ACCME (for CME) or COPE (for CE). For example, guidelines forbid speakers to be paid directly from commercial sponsors (and require speakers to disclose any related financial interests). Similarly, guidelines explicitly state that educational materials should not be promotional in nature. Many feel that these new guidelines are long overdue and an important step in medical education.

That being said, there also are many out there who are skeptical or uncertain about specific aspects of these guidelines. For instance, what exactly does "promotional" mean? Likewise, is continuing education going to become more difficult for eyecare practitioners to obtain with these new rules in place? Future interpretation of these rules, particularly by speakers, should prove interesting. Please provide us your thoughts on this topic in this week's CLToday Quick Poll.

Abstract

Health Care-Associated Invasive MRSA Infections, 2005-2008

Methicillin-resistant Staphylococcus aureus (MRSA) is a pathogen of public health importance; MRSA prevention programs that may affect MRSA transmission and infection are increasingly common in health care settings. Whether there have been changes in MRSA infection incidence as these programs become established is unknown; however, recent data have shown that rates of MRSA bloodstream infections (BSIs) in intensive care units are decreasing. These researchers wanted to describe changes in rates of invasive health care-associated MRSA infections from 2005 through 2008 among residents of nine U.S. metropolitan areas.

Active, population-based surveillance for invasive MRSA in nine metropolitan areas covering a population of approximately 15 million persons. All reports of laboratory-identified episodes of invasive (from a normally sterile body site) MRSA infections from 2005 through 2008 were evaluated and classified based on the setting of the positive culture and the presence or absence of health care exposures. Health care-associated infections (i.e., hospital-onset and health care-associated community-onset), which made up 82% of the total infections, were included in this analysis. Main outcome measures were change in incidence of invasive health care-associated MRSA infections and health care-associated MRSA BSIs using population of the catchment area as the denominator.

From 2005 through 2008, there were 21,503 episodes of invasive MRSA infection; 17,508 were health care associated. Of these, 15,458 were MRSA BSIs. The incidence rate of hospital-onset invasive MRSA infections was 1.02 per 10,000 population in 2005 and decreased 9.4% per year (95% confidence interval [CI], 14.7% to 3.8%; P = .005), and the incidence of health care-associated community-onset infections was 2.20 per 10,000 population in 2005 and decreased 5.7% per year (95% CI, 9.7% to 1.6%; P = .01). The decrease was most prominent for the subset of infections with BSIs (hospital-onset: -11.2%; 95% CI -15.9% to -6.3%; health care-associated community-onset: -6.6%; 95% CI -9.5% to -3.7%).

The authors concluded that over the 4-year period from 2005 through 2008 in nine diverse metropolitan areas, rates of invasive health care-associated MRSA infections decreased among patients with health care-associated infections that began in the community and also decreased among those with hospital-onset invasive disease.

Kallen AJ, Mu Y, Bulens S, et al. Health care-associated invasive MRSA infections, 2005-2008. JAMA 2010;304:641-648.


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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