A weekly e-journal by Art Epstein, OD, FAAO


Volume 14, Number 39

Monday, September 29, 2014


In this issue: (click heading to view article)
######### Off the Cuff: When is Enough Way Too Much?

######### The Heritability of Dry Eye Disease in a Female Twin Cohort
######### Conjunctival Sensitivity in Soft Contact Lens Wearers
######### Omega-3 Essential Fatty Acids Therapy for Dry Eye Syndrome
######### News & Notes

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Off the Cuff: When is Enough Way Too Much?

With a healthcare system in transition, optimistic ODs hope for expansion of our primary care responsibilities. While this is possible and perhaps even likely, the facts—facts supported by every workforce study going back to 1995—suggest that there are already more than enough ODs to fill increased needs for the foreseeable future.

Charles Mullen ( www.charlesmullen.com) recently published a guest editorial by Kenneth Myers that explored the issue in depth. It also examined the 2014 Eye Care Workforce Study conducted by Lewin Associates. Know that Mullin and Myers are among the most important and influential leaders in the modern history of our profession and neither have any axe to grind other than concern for our profession and patients.

In the editorial, Myers notes that since 2006, six new optometry schools have opened and three more are still planned. Since 1985, the number of graduates has increased from slightly over 1,000 to 1,600 this year, with more to come.

Consider all of this against the backdrop of an unstable healthcare environment, crippling student debt, shrinking applicant pools and the likelihood of technology-driven increases in practitioner efficiency. The impact on the profession remains to be seen, but from where I stand, the future is far less bright than it was when I started.

Optometry today is dramatically more advanced than it was in 1985. We owe that to the vision, commitment and tenacity of those who came before us. Likewise, we all share responsibility to those who will come after us. When asked about the future of our profession, honesty is not only the best policy, but it can also be a powerful tool in helping to balance the needs of the profession and our patients.

Arthur B. Epstein, OD, FAAO
Chief Medical Editor


Want to share your perspective? Write to Dr. Epstein at artepstein@optometricphysician.com.

The views expressed in this editorial are solely those of the author and do not necessarily represent the opinions of the editorial board, Jobson Medical Information LLC (JMI), or any other entities or individuals.




The Heritability of Dry Eye Disease in a Female Twin Cohort
A large sample of 3,930 female monozygotic and dizygotic twins from the UK Adult Twin Registry (TwinsUK) was questioned about the presence of a dry eye disease (DED) diagnosis and about DED symptoms in the preceding three months. In addition, a subset of 606 twins was examined for several dry eye signs. Genetic and environmental effects were estimated using maximum likelihood structural equation modeling.

All DED outcome variables showed higher correlation in monozygotic twin pairs than in dizygotic twin pairs, suggesting genes have a causative role in DED. DED symptoms showed a heritability of 29%. A clinician's diagnosis of DED with concurrent use of artificial tears showed a heritability of 41%. Estimates of the heritability of DED signs were 25% for inter-blink interval, 58% for Schirmer value, 40% for tear osmolarity, and 78% for the presence of blepharitis. The unique environment explained the remainder of the variance. We found no significant heritability for tear break-up time.

Genetic factors contribute moderately to the diagnosis, symptoms and the signs of DED. Compared to other ocular phenotypes, the lower heritability might reflect some of the difficulties in objective phenotyping of DED in a population-based sample. However, future genetic studies are now justified and may help in unraveling the pathophysiology of DED.

SOURCE: Vehof J, Wang B, Kozareva D, et al. The heritability of dry eye disease in a female twin cohort. Invest Ophthalmol Vis Sci. 2014; Sep 23. [Epub ahead of print].



Conjunctival Sensitivity in Soft Contact Lens Wearers
We determined the influence of soft contact lenses (SCLs) on conjunctival sensitivity. A total of 26 volunteers (11 males, 15 females; mean age 28.3 ± 4.6 years; range 22 to 39 years) without dry eye were enrolled in the study. Subjects with a low corneal touch threshold, atopic keratoconjunctivitis or vernal keratoconjunctivitis were excluded. In 26 participants, 12 were disposable SCL wearers. Touch thresholds were determined using a Cochet-Bonnet esthesiometer with a zero to 60 mm nylon monofilament in 5-mm increments. The length (mm) was converted to tension (g/mm²).

Mean touch sense thresholds in the SCL wearers (n=12) and non-wearers (n=14) were 10.7 ± 2.57 and 24.6 ± 7.3 g/mm² in the whole conjunctiva, and 9.07 ± 3.02 and 19.2 ± 7.8 g/mm² in the upper palpebral conjunctiva, respectively. Significant differences were observed in all locations.

The enhanced conjunctival sensitivity associated with SCL use may contribute to the dry eye-like symptoms in SCL users who do not have dry eye.

SOURCE: Igarashi T, Ono M, Fujimoto C, et al. The conjunctival sensitivity in soft contact lens wearers. Int Ophthalmol. 2014 Sep 7. [Epub ahead of print].



Omega-3 Essential Fatty Acids Therapy for Dry Eye Syndrome
Dry eye is a common, complex condition that can reduce ocular comfort and visual performance. The impact on quality of life has been rated as similar to the effect of moderate angina and, in more severe cases, dialysis and severe angina. This study aimed to use meta-analysis to compare omega-3 fatty acid and placebo fatty acid in the management of dry eye syndrome. Comparative studies published until June 1, 2014 were searched through a comprehensive search of the Medline, Embase, Web of Science and the Cochrane Library electronic databases. A systematic review and cumulative analysis of comparative studies reporting the effect of omega-3 fatty acid on dry eye syndrome was conducted. All analyses were performed using the Review Manager (RevMan) v.5 software (Nordic Cochrane Centre, Copenhagen, Denmark).

The trials involved a total of 790 participants in seven independent studies. All the studies are published between 2007 and 2013. Meta-analysis of the five studies that reported data in mean SD values revealed that the tear break-up time (TBUT) was significantly greater by 1.58 seconds. Combination of all the Schirmer's test data showed that omega-3 fatty acid supplementation could significantly improve the Schirmer's test. However, the combination of all the OSDI test data showed that omega-3 fatty acid supplementation did not significantly improve the OSDI test results.

Based on the data included in our meta-analysis, omega-3 fatty acid was associated with better TBUT and Schirmer's. No significant differences were detected in OSDI test results. Consequently, our findings suggest that omega-3 fatty acid offers is an effective therapy for dry eye syndrome.

SOURCE: Liu A, Ji J. Omega-3 essential fatty acids therapy for dry eye syndrome: a meta-analysis of randomized controlled studies. Med Sci Monit. 2014;20:1583–9.


News & Notes
GENZYME COLLABORATES ON GENE THERAPY FOR LEBER CONGENITAL AMAUROSIS TYPE 1. Genzyme, a Sanofi company, has established a research collaboration with the University of Florida and the University of Pennsylvania to develop a gene therapy for the treatment of Leber congenital amaurosis type 1, which is usually diagnosed in children less than one year of age and leaves them severely visually impaired for the rest of their lives. Genzyme is providing $900,000 in funding over three years to Dr. Shannon Boye, assistant professor of ophthalmology at the University of Florida, to fund her LCA-1 research. According to the company, the majority of the early stage LCA-1 research is being conducted at the University of Florida, with Genzyme taking on increasingly more activities as the program advances toward clinical trials. Genzyme has the option to in-license the potential treatment before it enters clinical trials. Get details on the gene therapy and more at www.genzyme.com.

POSITIVE RESULTS REPORTED FROM PHASE I STUDY OF CYCLASOL EYE DROPS. Novaliq GmbH has reported positive Phase I results with its CyclASol 0.05% cyclosporin solution eye drop formulation in clinical development for patients with dry-eye syndrome. The double-blind, randomized, placebo-controlled crossover study consisted of 18 patients and investigated safety, local tolerability and systemic exposure of CyclASol eye drops and vehicle following single and multiple ocular doses in healthy volunteers. According to Novaliq, no drug-related signs or symptoms of ocular discomfort or irritation were reported—in particular no dryness, grittiness, burning, stinging, tiredness, blurred or foggy vision, redness, watery eyes, eye mucus or crusting. In slit-lamp examinations, no subjects revealed any clinically abnormal signs of the anterior and posterior eye structures. Furthermore, with dosing of up to four drops per eye per day, no systemic levels of cyclosporin were detected after any dose or at any time point using a highly sensitive assay with a LLOQ as low as 0.1 ng/ml.

GLAUCOMA CANDIDATE VESNEO MEETS PRIMARY ENDPOINT IN PHASE III STUDIES. Valeant Pharmaceuticals International Inc.'s wholly owned subsidiary Bausch + Lomb and Nicox S.A. just announced positive top-line results from the pivotal Phase III studies conducted with the novel nitric oxide-donating prostaglandin F2-alpha analog Vesneo (latanoprostene bunod, previously known as BOL-303259-X and NCX 116) for the reduction of intraocular pressure in patients with glaucoma or ocular hypertension. The pivotal Phase III program includes two separate randomized, multicenter, double-masked, parallel-group clinical studies designed to compare the efficacy and safety of Vesneo administered once daily against timolol maleate 0.5% administered twice daily in lowering IOP in patients with open-angle glaucoma or ocular hypertension. These studies met their primary endpoint of non-inferiority to timolol maleate 0.5% and Vesneo showed a reduction in mean IOP of 7.9 mmHg to 9.1 mmHg from baseline between two and 12 weeks of treatment. They also showed positive results on a number of secondary endpoints. There were no significant safety findings in either study. Bausch + Lomb expects to submit a new drug application to the FDA for the approval of Vesneo in mid-2015.

SUCCESSFUL RESULTS FROM PHASE III STUDY OF SUB-MICRON LOTEPREDNOL ETABONATE OPHTHALMIC GEL, 0.38%. In a recent press release, Bausch + Lomb, a wholly owned subsidiary of Valeant Pharmaceuticals International Inc., revealed that its next-generation, sub-micron gel formulation of loteprednol etabonate was statistically superior to placebo (vehicle gel) in eliminating inflammation and pain following cataract surgery by study day eight, the primary endpoints in the first Phase III, multicenter, double-masked, vehicle-controlled, parallel-group study. According to the company, the new gel formulation features a sub-micron particle size, intended to enhance tissue penetration of the drug, and a lower concentration of loteprednol etabonate (0.38%) than its currently marketed Lotemax (loteprednol etabonate ophthalmic gel 0.5%). Information about a second Phase III trial of sub-micron loteprednol etabonate (0.38%) gel in recently initiated postoperative cataract surgery patients is available at www.clinicaltrials.gov. Bausch + Lomb expects to file a New Drug Application with the FDA for sub-micron loteprednol etabonate (0.38%) on the basis of data from these two studies in the second half of 2015.

NICOX COMPLETES ACQUISITIONS OF FRENCH OPHTHALMIC COMPANY AND CARRAGELOSE ANTI-VIRAL EYE DROP PROGRAM. Nicox S.A. has completed the acquisition of Doliage, a privately held French ophthalmic company, as part of its strategy to develop an ophthalmic commercial infrastructure in the five major European markets. The company also completed the acquisition of the Carragelose anti-viral eye drop program through the acquisition of AVEye Biotechnologie GmbH, a wholly owned affiliate of Marinomed Biotechnologie GmbH, which owns the entirety of the eye drop program. This particular acquisition provides Nicox with an innovative anti-viral ophthalmic product that could be launched in Europe within two years, pending CE marking, for the management of viral conjunctivitis. For more information, visit www.nicox.com.



Optometric Physician™ Editorial Board

Chief Medical Editor
Arthur B. Epstein, OD, FAAO

Journal Reviews
Shannon Steinhäuser, OD, FAAO

Contributing Editors
• Katherine M. Mastrota, MS, OD, FAAO
• Barry A. Weissman, OD, PhD, FAAO (Dip CL)

Editorial Board
• William Jones, OD, FAAO
• Alan G. Kabat, OD, FAAO
• Bruce Onofrey, RPh, OD, FAAO
• John Schachet, OD, FIOS
• Joseph Shovlin, OD, FAAO



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