As you have noted in various forums, the Unilateral Pricing Policy (UPP) that several contact lens manufacturers embraced is being discussed in many regards. We even saw this week that one of the manufacturers is moving away from their UPP, while another came out in support of their existing policy. It is unclear at this stage how the remainder of the industry will respond, but we will certainly keep you informed about this topic and corresponding developments as they arise.
Jason J. Nichols, OD, MPH, PhD
Alcon Launches Clear Care Rinse & Go
Alcon announced the newest addition to its contact lens care portfolio with the launch of Clear Care Rinse & Go, a gentle, saline solution for rinsing and temporary storage of contact lenses after cleaning and disinfection with Clear Care, Clear Care Plus or any other hydrogen peroxide solution. Clear Care Rinse &Go Solution is a sterile, buffered, isotonic, aqueous saline solution containing Polyquad (polyquaternium-1) 0.001% preservative, citrate, and edetate disodium (EDTA) 0.05%.
Clear Care Rinse & Go does not replace daily cleaning and disinfection of contact lenses, but is intended as a companion product to allow for rinsing of contact lenses, as needed, and for temporary storage of contact lenses, up to 30 days. Clear Care Rinse & Go will be available in two sizes – 12 fluid ounces and 4 fluid ounces – in most major mass, drug and grocery retailers in the U.S. in April 2016.
NAP Presents Weisbarth with the James A. Boucher Award of Excellence
Richard E. Weisbarth, OD, has received the National Academy of Practice in Optometry's James A. Boucher Award of Excellence for his "exemplary contributions to the profession of optometry and health care field" and for upholding the NAP's mission to advance science and the concept of interdisciplinary health care. NAP President Satya Verma, OD, FAAO, FNAP, Diplomate, presented Dr. Weisbarth with this prestigious award.
Weisbarth received his Doctor of Optometry degree from The Ohio State University College of Optometry in 1980. Following graduation, he served in the Contact Lens Practice Residency Program at the University of Alabama in Birmingham School of Optometry. He has conducted a private optometric practice and held several different positions in Clinical Research and Professional Affairs for CIBA Vision Corporation. Currently, he is Vice President, Professional Affairs for Alcon Laboratories.
Weisbarth has published and lectured internationally on a variety of contact lens and lens care related topics. His professional affiliations include being a Fellow of the American Academy of Optometry and a Diplomate in its Section on Cornea & Contact Lenses, a Fellow of the British Contact Lens Association, a Fellow of the International Association of Contact Lens Educators, as well as a Distinguished Practitioner in Optometry in the National Academies of Practice and a member of the Tear Film & Ocular Surface Society. Additionally, he has served in a number of leadership roles including on the American Academy of Optometry’s Executive Council and Board of Directors and was President of the organization in 2007 - 2008. Weisbarth is also the current Chairperson of the Contact Lens Institute and the National Academies of Practice in Optometry.
Contamac has been awarded a second Queen’s Award for Enterprise, this time in the Innovation category. The Queen’s Awards are the UK’s most prestigious business accolades and are awarded to businesses which have shown outstanding achievement in innovation, international trade and sustainable development. They are awarded by Her Majesty The Queen on recommendation from the Prime Minister.
Following on from the Queen’s Award for International Trade in 2012, this second award recognizes Contamac’s Definitive range of latheable silicone hydrogel materials, the first range of silicone hydrogel contact lens materials for the specialty contact lens industry.
Larry Alexander, OD, FAAO, 68, died in his Venice, Florida home on April 16, 2016. Originally from Plainfield, Indiana, Dr. Alexander graduated from Indiana University School of Optometry, served as an optometrist in the U.S. Navy, practiced in Elizabeth City, NC, taught at the University of Alabama Birmingham School of Optometry, practiced in Louisville, KY and Jeffersonville, IN and most recently consulted for Optovue. He was an educational author and lecturer who was passionate about his work.
Bausch + Lomb announced it has launched a 360-degree national consumer advertisement campaign, including television, digital, social media and in-office material challenging contact lens-wearers with the question, “Are your contacts still comfortable?,” to demonstrate how many digital screen-reliant contact lens wearers can often find their contact lenses uncomfortable. The campaign, starring the “Man of Comfort”, follows a patient throughout her busy day, inquiring at key moments if her B+L Ultra contact lenses are still comfortable.
The campaign encourages patients to visit www.stillcomfortable.com to learn more and obtain a trial certificate of B+L Ultra contact lenses.
Several national retailers announced the launch of a new coalition, the Coalition for Contact Lens Consumer Choice, which will oppose the Contact Lens Consumer Health Protection Act (CLCHPA) (S.2777) legislation recently introduced in the U.S. Senate. The group's initial members include 1-800 Contacts, Costco Wholesale and Lens.com.
Also, according to the coalition, since Monday, April 18, more than 17,000 individuals have signed a petition to Congress urging Senators and Representatives to reject the proposed legislation.
Avedro Receives FDA Approval for Photrexa Viscous, Photrexa and the KXL System for Corneal Cross-Linking
Avedro, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Photrexa Viscous, Photrexa and the KXL System. Photrexa Viscous and Photrexa are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus. Avedro’s Photrexa Viscous, Photrexa and the KXL System represent a first-in-class therapeutic treatment for this sight threatening indication.
The Photrexa formulations and the KXL System are expected to be available for qualifying patients through their ophthalmologists before the end of this year.
The approval was based on Avedro’s NDA submission which encompasses data from three prospective, randomized, parallel-group, open-label, placebo-controlled, 12-month trials conducted in the United States to determine the safety and effectiveness of Photrexa Viscous and Photrexa when used for performing corneal cross-linking in eyes with progressive keratoconus. These studies included Study 1, which enrolled 58 patients with progressive keratoconus, and Study 2, which enrolled 147 patients with progressive keratoconus. In each study, patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye.
The cross-linked eyes showed increasing improvement in Kmax from Month 3 through Month 12. Kmax is defined as the maximum corneal curvature and measured in diopters. Progressive keratoconus patients had an average Kmax reduction of 1.4 D in Study 1 and 1.7 D in Study 2 at Month 12 in the cross-linked eyes, while the untreated eyes had an average increase of 0.5 D in Study 1 and 0.6 D in Study 2 at Month 12; the difference (95% CI) between the cross-linked and untreated groups in the mean change from baseline Kmax was -1.9 (-3.4, -0.3) D in Study 1 and -2.3 (-3.5, -1.0) D in Study 2.
In clinical studies, the most common ocular adverse reactions in any cross-linked eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision.
Here is an example of dimple veiling causing subjective dryness and blurred vision in the periphery, especially at night. This patient is a first time contact lens wearer with moderate keratoconus. This finding and contact lens fit can be improved by flattening the base curve to reduce central pooling and tear stagnation. The edge can also be improved by steepening the peripheral curves to reduce excessive lift and bubbles pumped under the lens between blinks.
We thank Dr. Lundquist 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, MS, FAAO
Removing Contact Lens Case Biofilms
Bacterial biofilms are microbial communities that can adhere to surfaces.1 They form from planktonic cells (individual free-floating cells), can be composed of single or multiple types of bacteria, and they have increased resistance to antimicrobial products and the host immune response.1, 2 Biofilm formation can develop on surfaces within a few hours of contamination,1 a fact that is particularly important in the eye care arena because contact lens cases are known to develop biofilms.3 This issue is clinically important because biofilms decrease the effectiveness of contact lens care solutions, and because biofilms may increase one’s chances of contracting an infectious keratitis.1, 4 Therefore, preventing contact lens case biofilm formation should be a top priority.
In a 2010 study, Wu et al attempted to determine the most effective care regimen for removing bacterial biofilms from contact lens cases.5 In their study, they inoculated contact lens cases with common biofilm-forming bacteria, and they analyzed how care regimen steps affected contact lens case biofilm formation (no treatment, case rinsed with multipurpose solution, rubbing and rinsing the case with multipurpose solution, air drying the case face down, recapping the case, drying the case with tissue, and soaking the case in multipurpose solution).5 Wu et al found that the most effective means for reducing bacterial biofilms was rubbing and rinsing the cases with multipurpose solution and drying the cases with tissue, which indicated to the authors that application of mechanical force to the contact lens case may be the most important factor for removing stuck-on biofilms.5 Your patients may be surprised by the need for good case hygiene, so this is an especially important topic to add to your patient’s contact lens care plans.
1. Szczotka-Flynn LB, Imamura Y, Chandra J, et al. Increased resistance of contact lens-related bacterial biofilms to antimicrobial activity of soft contact lens care solutions. Cornea 2009;28:918-926.
2. Zegans ME, Becker HI, Budzik J, O'Toole G. The role of bacterial biofilms in ocular infections. DNA Cell Biol 2002;21:415-420.
3. Wu YT, Willcox MD, Stapleton F. The effect of contact lens hygiene behavior on lens case contamination. Optom Vis Sci 2015;92:167-174.
4. Stapleton F, Dart JK, Seal DV, Matheson M. Epidemiology of Pseudomonas aeruginosa keratitis in contact lens wearers. Epidemiol Infect 1995;114:395-402.
5. Wu YT, Zhu H, Willcox M, Stapleton F. Removal of biofilm from contact lens storage cases. Invest Ophthalmol Vis Sci 2010;51:6329-6333.
What equipment do you use to fit your contact lenses? Most of us would probably agree that we like to know the keratometry readings of our patients’ eyes and in many cases we use topography to measure corneal irregularity.
I'll be posting a tweet (@davekading) and Facebook post (davekading) later this weekend with a question as to what you use and why. I'd love to know your usage.
Several OCT companies have capitalized on the ability to measure corneal thickness and give us a pachymetry map. This may allow us to see corneal changes prior to topographical changes and may alter our future cross linking recommendations. Additionally we have one instrument about to be released which measures corneal epithelial thickness throughout the central cornea, and they are also releasing a contact lens module that will allow us to measure the Sag depth under a scleral lens in the central 6 mm of the lens all at once.
I'm excited for what is to come. It is going be awesome. Isn't technology fun?
Hypersensitivity to Cold Stimuli in Symptomatic Contact Lens Wearers
The purpose of this study was to examine the cooling thresholds and the estimated sensation magnitude at stimulus detection in controls and symptomatic and asymptomatic contact lens (CL) wearers, to determine whether detection thresholds depend on the presence of symptoms of dryness and discomfort.
Forty-nine adapted CL wearers and 15 non-lens wearing controls had room temperature pneumatic thresholds measured using a custom Belmonte esthesiometer, during Visits 1 and 2 (Baseline CL), Visit 3 (2 weeks no CL wear), and Visit 4 (2 weeks after resuming CL wear). CL wearers were subdivided into symptomatic and asymptomatic groups based on comfortable wearing time (CWT) and CLDEQ-8 score (<8 hours CWT and ≥14 CLDEQ-8 stratified the symptom groups). Detection thresholds were estimated using an ascending method of limits and each threshold was the average of the three first-reported flow rates. The magnitude of intensity, coolness, irritation, and pain at detection of the stimulus were estimated using a 1-100 scale (1 very mild, 100 very strong).
In all measurement conditions, the symptomatic CL wearers were the most sensitive, the asymptomatic CL wearers were the least sensitive, and the control group was between the two CL wearing groups (group factor p < 0.001, post hoc asymptomatic vs. symptomatic group, all p's < 0.015). Similar patterns were found for the estimated magnitude of intensity and irritation (group effect p = 0.027 and 0.006 for intensity and irritation, respectively) but not for cooling (p > 0.05) at detection threshold.
The researchers concluded that symptomatic CL wearers have higher cold detection sensitivity and report greater intensity and irritation sensation at stimulus detection than the asymptomatic wearers. Room temperature pneumatic esthesiometry may help to better understand the process of sensory adaptation to CL wear.
Situ P, Simpson T, Begley C. Hypersensitivity to Cold Stimuli in Symptomatic Contact Lens Wearers. Optom Vis Sci. 2016 Apr 4. [Epub ahead of print]