Infectious keratitis is the most substantial adverse event associated with contact lens wear. Many studies have shown that contact lens wear (particularly overnight wear) is associated with an increased risk for infectious keratitis. The abstract highlighted this week shows that even the unaffected eye in patients with unilateral keratitis is affected via a sympathetic immune response. We need to do all we can to prevent this horrible outcome in all of our patients.
Jason J. Nichols, OD, MPH, PhD
Shire Provides Update on Next Steps
Shire plc announced that the U.S. Food and Drug Administration (FDA) declined to approve and requested an additional clinical study as part of a complete response letter (CRL) to the company’s new drug application for lifitegrast for the signs and symptoms of dry eye disease in adults. Shire has recently completed a Phase 3 study of lifitegrast, OPUS-3, that, if positive, will be the basis of Shire’s response to the CRL. Topline results are expected before year-end.
The FDA also requested more information related to product quality, which Shire is confident it can address in the CRL response.
OPUS-3, a randomized, double-masked, 12-week Phase 3 study enrolled 711 patients to evaluate the efficacy and safety of lifitegrast. The clinical trial’s primary endpoint is patient-reported symptom improvement as measured by the Eye Dryness Score EDS scale.
The company anticipates resubmission to FDA the first quarter 2016, pending positive OPUS-3 outcomes, and plans continue for potential 2016 launch of lifitegrast.
New Grading Scales Available from BHVI
The Brien Holden Vision Institute (BHVI) launched new Grading Scales, which provide optometrists with an easy-to-use consulting room guide for the monitoring of common contact lens complications, and can be downloaded for free from the BHVI Academy website.
The Grading Scales reference tool provides a guide for determining the severity and progression of complications such as bulbar redness, limbal redness and corneal staining as well as descriptions and photographs of adverse effects associated with contact lens wear. The easy to use Grading Scales also allows optometrists to make consistent clinical management decisions.
The new Grading Scales can be downloaded for free from the Institute’s education website, https://academy.brienholdenvision.org. The Academy provides educational support to eye care personnel, optometry students and optometry schools.
Register Now for the 2016 GSLS – Take Advantage of Early Bird Savings
The 10th Global Specialty Lens Symposium will be held January 21 – 24, 2016 at Caesars Palace Las Vegas, Nevada. 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.
The 2015 event was attended by almost 600 registrants from 36 countries, 42 states, Puerto Rico and Guam. It continues to be the largest conference of its kind in the U.S.
Join your peers in 2016 for the 10th anniversary in Las Vegas! Visit www.GSLSymposium.com for more information and to register.
Allergan Launches Refresh Optive Gel Drops
Allergan announced the launch of the over-the-counter artificial tear Refresh Optive Gel Drops, a new aqueous gel designed for patients who need or desire a more viscous artificial tear option to relieve their dry eye symptoms. New Refresh Optive Gel Drops are formulated with glycerin and a unique blend of the active ingredient CMC which binds to the eye surface to provide long-lasting relief from dry eye discomfort.
According to the company, the innovative gel drops formula delivers a shear-thinning effect that spreads quickly and evenly over the eye surface to relieve dry eye symptoms while creating a soothing shield to protect the eye surface from hypertonic stress.
As the latest addition to Refresh Optive product line, Refresh Optive Gel Drops are a part of Allergan’s charitable program Refresh America to supply America’s heroic first responders with free eye drops. For every purchase of a package in the Refresh Optive product line between 8/1/15-7/31/16, Allergan guarantees a minimum product donation with an approximate retail value of $250,000.
Refresh Optive Gel Drops is available in 10 mL multi-dose bottles and can be found nationwide at various retail locations where OTC eye drops are sold. Learn more about Refresh Optive Gel Drops at www.refreshbrand.com.
Contamac Appoints Hibbs National Accounts Manager, Vision Care NA
Contamac announces the appointment of John Hibbs as National Accounts Manager, Vision Care North America.
John brings 30 years of experience in the contact lens industry with him and has gained an excellent reputation in the specialty contact lens industry for supporting and engaging in his customer’s long term growth strategies. The company announcement notes that Hibbs’ wealth of experience, coupled with the products and services that Contamac offers the North American market, will ensure continued support to their customers.
B+L Acquires Doctor’s Allergy Formula Diagnostic System
Bausch + Lomb announced that it has entered into a definitive agreement to acquire Doctor’s Allergy Formula, LLC, which will be integrated under the company’s pharmaceuticals division.
Doctor's Allergy Formula, LLC., provides a Food and Drug Administration approved proprietary diagnostic test which enables practitioners to objectively diagnose and identify the root cause of a patient’s ocular allergies. The three-minute ocular allergy diagnostic test utilizes a panel of 60 allergens that are specific to each region of the country and provides results within 15 minutes, according to the company.
The knowledge obtained from the Doctor’s Allergy Formula test results can help physicians identify the offending allergens and aid them in developing a customized treatment protocol. The Doctor’s Allergy Formula test helps to distinguish ocular surface disease pathology such as dry eyes, ocular allergies and blepharitis as routinely these signs and symptoms of OSD can be similar.
National Vision Announces New 2015-2016 Grant Program
National Vision, Inc. is encouraging students to pause and reflect on why they are interested in practicing primary care optometry and to consider the key issues affecting their future profession through a new 2015-2016 Grant Program. Third- and fourth-year optometry students from across the U.S. are all eligible to apply for the chance to win a $5,000 grand prize.
To enter, applicants must write a 500-word essay or create a short video describing their perspectives on the need for affordable, primary eye care in today’s changing healthcare environment. A flyer with additional information and requirement details can be found on the Student section of www.NVIOptometry.com.
All submissions and questions regarding the program should be sent to Mauricio.Wissinger@nationalvision.com by January 31. The winner, including two runner-up recipients, will be announced before March 1.
Corneal Decompensation Cyril Kahloun,MOptom, Jerusalem, Israel
This image shows corneal decompensation following intra-ocular ophthalmic surgery of a patient with Coats disease.
We thank Cyril Kahloun 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.
CARE SOLUTION CORNER Susan J. Gromacki, OD, MS, FAAO
Lotions and Soaps
A new scleral contact lens patient of mine reported today for his first follow-up examination. As post-LASIK ectasia patient, he was ecstatic with the improved vision and comfort he received with his contact lenses. However, he confessed that he almost called me on the second day of wear because of a profound blur that he was experiencing with his scleral lenses. After a day or two of this, he discovered that it had emanated from the hand lotion that he had utilized first thing in the morning, which had transferred to his lenses just prior to application.
Similarly, a recent poster at the American Academy of Optometry Annual Meeting this month presented the results of a study measuring the impact of washing hands with cream-based soaps prior to contact lens (CL) handling. The authors found an increase in silicone hydrogel contact lens diameter when using creamy soaps versus a control. They also detected some level of soap residue on the lenses, whether using a creamy or a clear soap. They concluded, “Soap residue could potentially be transferred to the CL and contribute to reduced vision and comfort. This study confirms the need to educate patients about properly rinsing off hand soap to limit soap residue on a CL surface.”
To conclude, patients should apply hand lotion only after inserting or removing their contact lenses. In addition, it is most prudent for contact lens wearers to utilize a clear soap, with no creamy lotion or perfume additives, and to make sure that it is completely rinsed off prior to handling their lenses.
Bitton E, Kronish S, Bouchard J-F et al. The impact of hand rinsing time on soap residue left on the surface of silicone hydrogel CL. Opt Vis Sci 2015;92:E-abstract 155255.
From what I see about new materials technology and the way that lenses have been released into the market over the last two years, I am pleased that almost all of them (not every one) bring something new that we have not seen before. Whether it is a new surface treatment, a new way to present the surface to the eye, or innovation that resembles the tear film, we are innovating beyond materials that are just more oxygen permeable (although this is critically important as well).
We all see statistics of contact lens wearers who have dropped out of lens wear or who are uncomfortable with their current lenses and we know that companies are working to produce contact lenses that help these patients. Albeit true, we must remember that prior to our patients becoming uncomfortable with their current contact lens, they felt the benefit from the innovation of old. So we need to keep in mind that our patients remain on a dry eye or ocular surface continuum that must be met first with treatments targeting the root cause. Does this mean that lenses of old are as good as lenses of new? Not necessarily. I honestly believe that our patients should be fit in the lenses that promote the best ocular environment. I believe this to be innovative, breathable, ocular surface aiding contact lenses. Fortunately we have many of them (and more on its way). However, as you bring your patients back to the office and present them with what is best for them in new contact lens options, remember to stop and reflect on what may be the underlying cause of their discomfort. Does a lens switch heal the ocular surface? Not yet in my estimation, and as such I want to bring about successful ocular surface treatments and then maximize them with innovative materials and designs.
Contralateral Clinically Unaffected Eyes of Patients with Unilateral Infectious Keratitis Demonstrate a Sympathetic Immune Response
The purpose of the study was to analyze the contralateral unaffected eyes of patients with microbial keratitis (MK) for any immune cell or nerve changes by laser in vivo confocal microscopy (IVCM).
A prospective study was performed on 28 patients with MK, including acute bacterial, fungal, and Acanthamoeba keratitis, as well as on their contralateral clinically unaffected eyes and on control groups, which consisted of 28 age-matched normal controls and 15 control contact lens (CL) wearers. Laser IVCM with the Heidelberg Retinal Tomograph 3/Rostock Cornea Module and Cochet-Bonnet esthesiometry of the central cornea were performed. Two masked observers assessed central corneal dendritiform cell density and subbasal corneal nerve parameters.
The contralateral clinically unaffected eyes of patients with MK demonstrated significant diminishment in nerve density (15,603.8 ± 1265.2 vs. 24,102.1 ± 735.6 μm/mm2), total number of nerves (11.9 ± 1.0 vs. 24.9 ± 1.2/frame), number of branches (1.7 ± 0.2 vs. 19.9 ± 1.3/frame), and branch nerve length (5775.2 ± 757.1 vs. 12,715.4 ± 648.4 μm/mm2) (P < 0.001 for all parameters) compared to normal controls and CL wearers. Further, dendritiform cell density in the contralateral unaffected eyes was significantly increased as compared to that in controls (117.5 ± 19.9 vs. 24.2 ± 3.5 cells/mm2, P < 0.001).
The researchers concluded that the study demonstrated a subclinical involvement in the contralateral clinically unaffected eyes in patients with unilateral acute MK. In vivo confocal microscopy reveals not only a diminishment of the subbasal corneal nerves and sensation, but also an increase in dendritiform cell density in the contralateral unaffected eyes of MK patients. These findings show bilateral immune alterations in a clinically unilateral disease.
Cruzat A, Schrems WA, Schrems-Hoesl LM, Cavalcanti BM, Baniasadi N, Witkin D, Pavan-Langston D, Dana R, Hamrah P. Contralateral Clinically Unaffected Eyes of Patients with Unilateral Infectious Keratitis Demonstrate a Sympathetic Immune Response. Invest Ophthalmol Vis Sci. 2015 Oct 1;56(11):6612-20. doi: 10.1167/iovs.15-16560.