On Jan. 25 to 28, 2018 at the Tropicana in Las Vegas, we will hold our 12th annual Global Specialty Lens Symposium (GSLS). As is usual, the meeting will be jam-packed with outstanding content, related not only to specialty lenses, but really to all aspects of contact lens wear including lens care, ocular surface and contact lens fitting evaluation, dry eye, among many other topics. The GSLS has grown to be one of the largest and most wide-ranging contact lens meetings in the world, and we hope that you are able to attend. If not, stay tuned for a comprehensive summary of the meeting to be published in the next few months in Contact Lens Spectrum.
Jason J. Nichols, OD, MPH, PhD
Bausch + Lomb Receives FDA Approval of Lumify
Bausch + Lomb announced that the U.S. Food and Drug Administration (FDA) has approved Lumify (brimonidine tartrate ophthalmic solution 0.025%), an over-the-counter (OTC) eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness. Brimonidine, which was first approved by the FDA in 1996 for intraocular pressure (IOP) reduction in glaucoma patients, is available at higher doses in prescription eyecare products. The brimonidine tartrate ophthalmic solution 0.025% product was licensed by Eye Therapies, Inc. to Bausch + Lomb.
CooperVision Introduces MyDay Toric Daily Disposable Lenses in the United States
CooperVision, Inc. introduced MyDay toric daily disposable contact lenses in the United States. The MyDay toric lenses feature the same Optimized Toric Lens Geometry found in Biofinity toric, providing uniform horizontal ISO thickness, an optimized ballast band design, a large toric optic zone, and a smooth, continuous surface. In addition, the MyDay family of lenses is made with Smart Silicone chemistry, which optimizes oxygen permeability in a lens that is just 4.4% silicon—the lowest percentage of silicon found in a silicone hydrogel, one-day lens, according to the company.
MyDay toric lenses are currently available in sphere powers from plano to –6.00D (in 0.25D steps) and from –6.00D to –10.00D (in 0.50D steps), with cylinder options of –0.75D, –1.25D, and –1.75D in axes of 10°, 20°, 70°, 80°, 90°, 100°, 110°, 160°, 170°, and 180° and –2.25D in axes of 10°, 20°, 90°, 160°, 170°, and 180°. Plus powers will be added soon. MyDay toric lenses have a base curve of 8.6mm and a diameter of 14.5mm.
FDA Accepts Sun Pharma’s NDA for Dry Eye Candidate
According to Sun Pharmaceutical Industries, the U.S. Food and Drug Administration (FDA) has accepted Sun Pharma’s new drug application (NDA) for OTX-101 for dry eye disease. OTX-101 (cyclosporine A, ophthalmic solution) 0.09% is a novel nanomicellar formulation in a clear, preservative-free, aqueous solution. The NDA was filed by Sun Pharma’s wholly owned subsidiary, Sun Ophthalmics. If eventually approved by the FDA, OTX-101 would be the third pharmaceutical drug for dry eye disease approved in the U.S. market.
Art Optical Introduces KeraSoft Thin to U.S. Marketplace
Under license from UltraVision CLPL, Art Optical is now manufacturing and supplying KeraSoft Thin prescription SiHy contact lenses in the United States.
According to the companies, KeraSoft Thin is the combination of advanced lathing technology and innovative lens design resulting in the thinnest soft contact lens available for the irregular cornea. The thinner design improves wearing comfort and increases oxygen transmission through the lens, which is particularly important to more vulnerable corneas. The ultra-thin design also increases lens flexibility for improved drape over the cornea, reducing the need for peripheral adjustments on complex corneas, according to the companies.
KeraSoft Thin is fit with the aid of an eight-lens diagnostic set; additional fitting resources, training aids, and a practitioner locator are available at kerasoftlens.com. Manufactured in Definitive silicone hydrogel material from Contamac and backed by Art Optical’s comprehensive warranty programs, KeraSoft Thin lenses are manufactured and shipped in two to three days. Intended for quarterly replacement, KeraSoft Thin is available in single vials as well as multipacks.
TearLab Submits 510(k) for U.S. FDA Clearance of TearLab Discovery Platform
TearLab Corporation has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the potential clearance of its TearLab Discovery Platform, the company’s next-generation in-vitro diagnostic testing system. The submission covers the TearLab Discovery Platform and a test card measuring the matrix metalloproteinase-9 (MMP-9) inflammatory biomarker. TearLab Discovery will also be capable of performing TearLab’s current FDA-cleared tear osmolarity test.
TearLab plans to file for Waiver categorization with the FDA under the Clinical Laboratory and Improvement Amendments (CLIA) after it receives FDA 510(k) clearance for the TearLab Discovery Platform to allow the test to be performed at the point-of-care. Both the MMP-9 predicate device and the current TearLab osmolarity test have existing CLIA Waivers to allow point-of-care testing. In the interim, the company will continue to build the clinical data package for the commercial launch of the TearLab Discovery Platform, which it expects after securing both the FDA clearance and the CLIA waiver.
AccuLens Announces Equipment Upgrades
AccuLens announced that it has upgraded its current CNC/DAC lathes as well as all ancillary equipment. Upgrades include high-speed air-cooled spindles, which allow a higher level of optics to be achieved. With these machine updates, the capability to manufacture lenses that reduce spherical aberrations (high-definition optics) is increased due to the shorter polishing times, according to the company.
AccuLens says it has the capability to manufacture custom scleral and corneal GP designs in a wide range of multifocal options, and these upgrades expand this ability.
Nicox Appoints Tomas Navratil, PhD, Head of Development
Nicox SA appointed Tomas Navratil, PhD, vice president and head of development. In this newly-created position, Dr. Navratil will be responsible for leading all of the company's non-clinical and clinical development activities. He will report to Michael Bergamini, PhD, executive vice president and chief scientific officer of Nicox.
Dr. Navratil brings to Nicox significant experience in the biotechnology industry and has been involved with the discovery and development of new chemical entities, novel medical devices, and biodegradable implant formulations focused on improving drug delivery, Phase 1-4 clinical programs, and regulatory submissions to the U.S. Food and Drug Administration and the European Medicines Agency.
Prior to joining Nicox, he served as senior vice president of development at Envisia Therapeutics, a privately held biotechnology company focused on the development of novel ocular therapies. Before that, he was at Parion Sciences, where he served as executive director of clinical research and product development. Previously, Dr. Navratil held several director-level positions in drug discovery and clinical development at Inspire Pharmaceuticals, most recently as director, medical & scientific affairs.
Xiidra Approved by Health Canada to Treat the Signs and Symptoms of DED
Shire plc announced that Xiidra (lifitegrast ophthalmic solution 5%), a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adults, has been approved in Canada, marking the first international approval for the treatment outside of the United States. Xiidra will be available for patients in Canada early this year.
ABB Optical Group Adds Mike Evans to Sales Team
ABB Optical Group has hired industry veteran Mike Evans as the company’s area sales director of the west. Prior to joining ABB Optical, Mr. Evans was the vice president of sales for Professional Eyecare Resource Co-Operative (PERC), a doctor alliance group with 4,000 members, and Infinity Vision Alliance (IVA). He previously held senior sales positions with Johnson & Johnson/Vistakon as well as several other healthcare-focused companies.
Additionally, Brad Amstutz, who managed the company’s mid-Atlantic sales team, has been promoted to area sales director of the east. Mr. Amstutz also will focus on continued growth of daily disposables, specialty lenses, and lab orders as ABB Optical’s area sales director of the east.
In addition, Glenn Senese, who formerly held the east sales director role, will move to the new position of director of new business development. In his new role, Mr. Senese will focus on developing new business for ABB Optical, including maximizing lab opportunities.
The Research Academy to Encourage Research Funding in Optometry and Vision Science
The American Academy of Optometry announced a new program, The Research Academy, to be held in Columbus, Ohio, July 17-19, 2018. The goal of the program is to help optometry faculty attendees develop ideas that will result in extramural funding for both basic and patient-oriented research in optometry and vision science.
The program will facilitate collaboration among attendees, and their ideas and research approaches will be critically evaluated by experienced researchers who have a history of extramural funding, and by National Eye Institute staff. The program will include a mock National Institutes of Health-style study section so that attendees can experience how submitted grants are reviewed. Components of a viable research idea, an overview of the National Eye Institute, and federal changes to the regulations that govern biomedical research will be emphasized.
The ideal attendee will either be engaged in current, formal research training or has a research-related degree and/or equivalent experience. Onsite costs of the program will be sponsored by the Academy, and attendees and/or their academic institutions will be responsible for transportation expenses.
Applications and additional information can be found at https://www.aaopt.org/home/the-research-academy. The application window will be open until Jan. 16, 2018. Early applications are encouraged, as admission will be on a rolling basis.
Three Weeks till GSLS 2018
Hear the latest contact lens insights, clinical advancements, and technology improvements from world-renowned speakers. Register today and earn up to 35 CE hours. COPE, NCLE, JCAHPO, and Florida Board of Optometry credits available. www.GSLSymposium.com
Do you think daily disposable contact lens wearers are more likely to purchase their contact lenses online compared with other soft lens-wearing patients?
This image shows a corneal graft with a scleral contact lens that was prescribed by another contact lens practitioner. I put fluorescein over the lens and, just as I pushed a little at the 12 o'clock location, a river started to flow under the lens.
We thank Kyriakos Telamitsi for this image and 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 a detailed explanation of the photo and your full name, degree or title, and city/state/country.
CARE SOLUTION CORNER
Andrew D. Pucker, OD, PhD
A New Year’s Resolution
The start of a new year is an opportunity to reflect. And, for many, it is the time to make New Year’s resolutions. New Year’s resolutions are most commonly related to health issues (e.g., smoking cessation, weight loss),1 though some practitioners may want to achieve professional objectives or to help others, such as their patients, achieve their personal goals.
Unfortunately, long-term achievement of a New Year’s resolution is somewhat uncommon. In fact, Norcross and Vangarelli found that while 77% of resolvers were able to adhere to their goal for one week, only 55%, 43%, 40%, and 19% of resolvers were successful at one month, three months, six months, and two years, respectively.1 Interestingly, they also found that long-term success was associated with environmental re-evaluation, helping relationships, interpersonal systems control (avoiding individuals or situations that negatively influence behavior), reinforcement management (rewarding yourself), and stimulus control (reminders to avoid problem).1 At the same time, unsuccessful people exhibited more self-blame.1 Subjects also indicated that they found counterconditioning (changing response to stimuli), gradual behavior reduction, stimulus control, and contingency management the most helpful for modifying their behaviors.1
While it is unlikely that our patients will resolve to improve their contact lens care and compliance, they may wish to avoid another contact lens-related red eye, or they may just want to live a healthier lifestyle. In either instance, I encourage you to make one of your New Year’s resolutions to actively encourage your patients to fully care for their eyes and contact lenses. I also urge you to educate your patients about the above traits and to tell them that it is OK to make mistakes from time to time, as long as they reflect upon those mistakes and avoid them in the future.1
1. Norcross JC, Vangarelli DJ. The resolution solution: longitudinal examination of New Year's change attempts. J Subst Abuse. 1988-1989;1(2):127-134.
MATERIALS & DESIGNS
David L. Kading, OD
Always More to Learn
The Global Specialty Lens Symposium (GSLS) never ceases to amaze me. Last year’s meeting was no exception. I have been attending the meeting every year since it started, and every so often I think to myself, “I am a specialty lens fitter, I do this every day, what more could I learn? I am sure that this will be the year that I will have learned it all and can stop going.” Nope—I learn more about contact lenses and the ocular surface each and every year I attend.
The meeting is always highlighted by the education. I am eager to attend this year’s meeting because the course and speaker lineup is again stellar. However, another thing I really like about this meeting is the opportunity to network with industry and other colleagues. If you have attended any eyecare conference, you know that there is exhibit time and lecture time. What makes the GSLS meeting unique is how they merge so closely together.
If you have read my articles in the past, you know that I am a huge fan of industry. I know that my laboratory teaches me about contact lens fitting. I know that the pharma companies help me learn more about disease. My relationship with industry is a symbiotic one. The better they are, the better I am, and most importantly, the better my patients are. I want to learn as much as I can from them. At the GSLS, you get that opportunity.
As you head into your new year, I’d love to encourage you to make plans to attend the meeting. As a contributor to this Materials & Designs column for the last couple years, I can honestly say that all materials and design are well represented at GSLS. Do yourself and your patients a favor and attend the 2018 meeting.
If you find that you knew it all ahead of time, I’ll tip my hat to you—you are a wise cat. But if, like me, you take away at least five tidbits that make you better, you’ll be glad you went.
Orthokeratology and Contact Lens Quality of Life Questionnaire (OCL-QoL)
The purpose of this study was to develop a quality of life (QoL) instrument for patients fitted with orthokeratology (ortho-k) and other modalities of contact lenses.
A 45-item pilot questionnaire was developed from an extensive literature review, focus groups, and interviews. Subsequently, 234 participants fitted with contact lenses (ortho-k, soft, and GP lenses) or spectacles completed the pilot questionnaire. Rasch analysis was used to assess the psychometric properties in terms of person separation, item fit statistics, category threshold ordering, differential item functioning (DIF), and targeting. A subset of participants completed the final questionnaire twice (one week apart), and the repeatability was assessed (within-subject standard deviation). The Spearman rank-order correlation coefficient between the questionnaire score and binocular visual acuity was calculated to assess construct validity.
Inspection of category probability curves suggested that one category was underused, and the response options were collapsed. Furthermore, Rasch analyses indicated that 22 items misfitted the model and were removed. The final questionnaire contained 23 items with a person separation of 2.18, item fit statistics within the range of 0.83 to 1.15, targeting 1.05 logits, and no significant DIF (< 0.8 logits). The repeatability (Sr) was 4.21, and there was no correlation between questionnaire scores and binocular visual acuity (rs = 0.03, p = 0.65).
The study determined that the Orthokeratology and Contact Lens Quality of Life Questionnaire demonstrated excellent psychometric properties and is capable of measuring vision-related QoL in patients fitted with various forms of contact lenses including ortho-k lenses. The tool is scored on a 0 to 100 interval level scale, with higher scores indicating better QoL.
McAlinden C, Lipson M. Orthokeratology and Contact Lens Quality of Life Questionnaire (OCL-QoL). Eye Contact Lens. 2017 Dec 5. [Epub ahead of print]