The upcoming holidays present a great time for you and your staff to encourage family-related office visits. It is an opportune time to proactively promote contact lens fitting in your teen and presbyopic patients. It has been well documented that the non-contact lens wearer is typically the one to initiate dialogue about wearing contact lenses. I believe this is an auspicious time for us to reverse this trend as there have been tremendous advances in the contact lenses, such that we can offer nearly every potential contact lens wearer an opportunity to enhance their vision with contact lenses.
Jason J. Nichols, OD, MPH, PhD
FTC Proposes Contact Lens Rule Changes
The Contact Lens Rule, in place since August 2004, among other provisions requires the prescriber to provide the patient with a complete copy of the contact lens prescription and to verify or provide the prescription to authorized third parties. The FTC has now proposed amendments which include a provision to require contact lens prescribers to obtain a signed acknowledgement after releasing a contact lens prescription to a patient, and to maintain it, either paper copy or electronically, for at least three years. The form would state: "My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand that I am free to purchase contact lenses from the seller of my choice."
The proposed updates to the rule also include that additional copies of prescriptions be furnished upon request, clarify the requirements related to prescribers providing prescriptions to third parties acting on the patient's behalf, and recommend using online portals for patients to access their prescriptions. The proposed amendments are published in the Federal Register.
Alcon Dailies AquaComfort Plus contact lenses will receive new U.S. only packaging with a refreshed design, patient education information and instructions in the new year.
The packaging will contain new educational elements, including illustrated instructions for lens preparation, insertion and removal; a patient helpline and email address; and the Dailies website address. Additionally, the U.S. flag symbol will appear on the packaging so that ECPs and their patients are assured that the product was meant for sale in the United States. It will replace prior packaging and will be the only Dailies AquaComfort Plus packaging that Alcon issues into the U.S. market.
The packaging is expected to roll out in the second quarter of 2017.
Save With Early Bird Pricing for GSLS – Register Before December 1
The 2017 Global Specialty Lens Symposium will be held January 26-29, 2017 at the Rio Hotel in Las Vegas, Nevada. Special savings are available to those who regisiter before December 1.
The GSLS is a must-attend meeting, brought to you by Contact Lens Spectrum, focusing on the successful management of ocular conditions using today's specialty contact lenses. This meeting will include insightful presentations by international experts in the field, hands-on demonstrations of cutting-edge products and valuable continuing education credits.
CooperVision’s Best Practices Submission Deadline Approaches
Eyecare practices from all over the United States have the opportunity to be recognized for the innovative and unexpected things they do every day to overcome challenges and grow their businesses—but time is running out. CooperVision, Inc. is reminding ECPs that the deadline for submission for its second annual Best Practices initiative is November 27.
All U.S. optometry practices currently fitting contact lenses are invited to participate. Best Practices candidates are encouraged to submit practice profiles and stories, sharing their insights and experiences in all of the following areas:
Innovation will be evaluated on contributions to the betterment of eye health and education, leveraging technology in interesting ways to grow the practice, and advancing the eye care profession among the public.
Industry Leadership will be rated on how a practice advances the profession and leads the industry regionally, nationally, and even globally.
Patient Experience will be judged on how a practice delivers excellent eye care experiences and education to its patients, and unique aspects of patient care.
Candidates can choose to submit their stories by November 27 via written responses or video at EyeCareBestPractices.com. The 2017 Best Practices will be named in early 2017.
RegeneRx Enrolls First Patients in Phase 3 U.S. DE Clinical Trial
RegeneRx Biopharmaceuticals, Inc. has enrolled the first patients in a Phase 3 clinical trial (ARISE-2 trial) with RGN-259 (Thymosin beta 4), its sterile, preservative-free eye drop formulation developed for patients with dry eye syndrome, neurotrophic keratopathy (NK), and other corneal disorders.
The primary endpoints of the ARISE-2 trial are the change in ocular discomfort and the change in inferior corneal staining at baseline (prior to first dose) and at the end of treatment (after last dose) in a controlled adverse environment (CAE). According to the company, these are the same efficacy assessments under CAE that showed strong statistical significance in the Phase 2b/3 trial (ARISE-1) that was reported earlier this year.
The double-masked, placebo-controlled trial is being sponsored by ReGenTree LLC, a joint venture between RegeneRx and GtreeBNT Co. Ltd., and is being conducted by Ora Inc., an established contract research organization specializing in the field of ophthalmology. ARISE-2 is being conducted at multiple sites in the U.S., will enroll approximately 500 dry eye patients, and is expected to be completed and patient data reported in Q4 2017. There will be numerous secondary endpoints and other safety and efficacy parameters that will also be evaluated pursuant to the trial protocol.
Thymosin beta 4 (Tβ4), the active ingredient in RGN-259, is a first-in-class, naturally occurring molecule that has been the subject of numerous published animal studies in the fields of ophthalmology, dermatology, cardiology, and central nervous system disorders, among others. In addition to the animal studies, the molecule has been tested in three unique formulations and routes of administration in approximately 650 patients and has an excellent safety profile.
Contact lens dropout is a major concern when as an industry we are striving to grow the number of people utilizing these marvelous devices. Contact lens dryness and discomfort have been thought to be the primary drivers of contact lens dropout; however is there a difference in rates and causes of dropout when we compare various modalities of lens wear and other factors?
A recently published study attempted to determine the first-year retention rate for patients fitted with contact lenses (CLs) and identify factors associated with retention and dropout.1 This multi-site study was a retrospective chart review of the status of neophyte CL wearers fit in representative UK eyecare practices. Consecutive records for 524 patients at 29 sites were reviewed. Soft CLs were fit to 98% of patients. After 12 months, 388 were still CL wearers, a retention rate of 74% (95% CI: 70.1-77.6). Of the 136 lapsed, 25% discontinued during the first month and 47% within 60 days. The main reasons cited for discontinuation included poor distance vision (26%; of whom 37% were toric and 51% multifocal), poor near vision (16%), discomfort (14%) and handling problems (15%). In 32% of cases, the reasons for discontinuation were unknown. For 71% of dropouts, no alternative lens or management strategy had been tried. Multivariate analysis showed lens sphere power, purchase frequency and lens material to be significant factors. There was a wide variation in retention rates between sites (40-100%). During the first year of CL wear, the overall retention rate for neophyte CL wearers was 74% (spherical CLs 79%, torics 73%, multifocals 57%), with many lapsing during the first 2 months. Factors associated with retention and dropout in these patients include: lens power, material and type, and purchase frequency. While handling and comfort are the most commonly cited performance-related reasons for discontinuing in new spherical lens wearers, visual problems are the most common among new wearers of toric and, in particular, multifocal CLs.
So, in this study things are more complex when looking at contact lens dropout. For example, it seems like optical modality of lenses (sphere vs. toric vs. multifocal) was important. The more complex designs were associated with higher dropout rates and the reason for dropout in those cases was primarily visual performance. Of further interest is the finding here that overall dropout rate was about 20%. We see this number coming up time and time again across all contact lenses. In fact, a study that reported CL dropout rates after the first year of lens wear with daytime use daily wear spherical SCLs vs. overnight corneal reshaping lens wear found a rate of about 20% for both modalities.2 As the study reported here, the reasons for dropout and the time frame for dropout varied between the two modalities.
Contact lens dropout remains a challenge to the ongoing success and growth of the CL industry. By better examining the specifics associated with dropout we may be able to address the issues and impact the dropout rates.
1. Sulley A, Young G, Hunt C. Factors in the success of new contact lens wearers. Cont Lens Anterior Eye. 2016 Nov 3 [Epub ahead of print].
2. Eiden SB, Davis R, Bennett E, DeKinder J. SMART Study: Background, Rationale, and Baseline Results. Contact Lens Spectrum, Issue: October 2009.
OCULAR SURFACE UPDATE Katherine M. Mastrota, MS, OD, FAAO
Alcohol Consumption and Dry Eye
As we learn more about dry eye/ocular surface disease, we appreciate the dynamic nature of symptomatology in our dry eye patients. One variable to be considered in our dry eye patients is alcohol consumption.
A recent meta-analysis of published case-controlled and cross-sectional studies on alcohol consumption and dry eye risk aimed to quantify the association between them.1
A total of 10 studies were included in this meta-analysis. The pooled results showed that alcohol consumption significantly increases the risk of dry eye syndrome based on typical symptoms and positive objective tests. These results were independent of smoking, hypertension, diabetes and thyroid disease history. Interestingly patients who engaged in any alcohol consumption were at higher risk of suffering from dry eye syndrome while heavy drinkers were not. The authors suggest that alcohol consumption may be a significant risk factor for dry eye syndrome, however alcohol-induced peripheral neuropathy, which reduces corneal sensitivity, may result in an under estimation of dry eye syndrome prevalence among heavy drinkers. Some researchers have reported the presence of ethanol in tears after alcohol consumption was significantly related to decreased tear-film volume, disturbed tear-film structure, and deteriorated tear film. Tear hyperosmolarity, which is highly related to the increased prevalence of dry eye syndrome, was also detected after heavy drinking. Ethanol in tears could also induce the increased expression of proinflammatory cytokines (e.g. IL-1β, IL-6, and IL-8) in corneal stromal cells and epithelial cells. These findings indicate that controlling alcohol consumption may help to reduce dry eye syndrome prevalence.
1. You YS, Qu NB, Yu XN. Alcohol consumption and dry eye syndrome: a Meta-analysis. Int J Ophthalmol. 2016; 9(10): 1487–1492.
Proper Balance of Omega-3 and Omega-6 Fatty Acid Supplements with Topical Cyclosporine Attenuated Contact Lens-Related Dry Eye Syndrome
Essential fatty acids had been applied in the treatment of dry eye syndrome (DES), but the effects of different combinations of fatty acids have not been investigated. This double-blinded study included 360 long-term contact lens wearers. Omega-3 and omega-6 fatty acids were combined in different ratios and supplied to the participants that were randomly divided into six groups, and the effects of different essential fatty acids mixture on DES with or without topical cyclosporine were investigated. More than half of long-term contact lens wearers suffered from DES, which were found to be attenuated by oral supplement of properly balanced O3FA and O6FA fatty acid. The topical cyclosporine treatment considerably inhibited the production of cytokines compared to the cyclosporine negative groups, which further relieved DES. Proper balance of omega-3 and omega-6 fatty acid combination significantly alleviated contact lens-related DES.
Wang L, Chen X, Hao J, Yang L. Proper balance of omega-3 and omega-6 fatty acid supplements with topical cyclosporine attenuated contact lens-related dry eye syndrome. Inflammopharmacology. 2016 Oct 20. [Epub ahead of print]