We generally know that inflammation is at least associated, if not causative, in many ocular surface conditions. But, I am not sure that we know or understand the role of inflammation in contact lens wear—either in normal/asymptomatic contact lens wear or when someone has contact lens dry eye or discomfort. For instance, do inflammatory mediators increase in the tear film over the course of a day's wear, corresponding to increased dryness and discomfort during this period? I think this is fundamental information that is critically in need of further study.
Alden Optical introduced Astera Multifocal Toric at the 2012 American Academy of Optometry Meeting. Astera Multifocal Toric offers practitioners a performance option for presbyopes who can benefit from custom lens prescriptions and/or astigmatic correction.
Alden Optical partnered with Precilens, a leading European manufacturer, to incorporate into the design their C2 center-near multifocal optics which feature large stabilized spherical zones at near and distance. According to the company, Astera Multifocal Toric further benefits from Alden Optical's proprietary Dual Elliptical Stabilization which ensures outstanding orientation and rotational stability. Astera Multifocal Toric is available in custom prescriptions and multiple replacement cycles. Astera is also available without cylinder for spherical wearers who require custom lens prescriptions or designs.
Blanchard Contact lens Laboratories launched two new mini-scleral GP lenses, the Onefit P+A series and the Onefit C series.
The Onefit P+A series is designed to completely vault corneas with a normal prolate profiles, astigmatic corneas, post-surgical (grafts, post-RK, LASIK, PRK), moderately irregular corneas, emergent or fruste keratoconus cases, soft lens patients with end-of-day dry eye comfort compromise and moderate ocular surface disease. According to the company, primary applications are for the young contact lens patient, sports active adult and youth, patients presenting with dry eye issues and GP intolerant patients who find compromised visual acuity, marginal fitting success or lens longevity issues with hybrid, spherical soft and soft toric lenses.
The Onefit P+A series will include a presbyopic anterior surface design option in Q1 2013, featuring a low and high add option.
The Onefit C series mini-scleral lenses are designed specifically to accommodate the highly irregular topography of keratoconic corneas. The vault and peripheral system provide a simplified easy to use intuitive approach to fitting, per the company, and the unique design delivers extended hours of comfortable wear and quality of vision with a larger posterior optical zone for improved vision performance.
SARcode Bioscience, Inc. announced topline results from OPUS-1, a Phase 3 study of lifitegrast ophthalmic solution, 5.0%, versus placebo for the treatment of dry eye disease. In the study, which included 588 subjects, lifitegrast demonstrated superiority over placebo in the improvement of inferior and total corneal staining scores from baseline to week 12 (P=0.0007 and P=0.0148, respectively). Ocular surface damage, which is a hallmark of chronic inflammation from dry eye disease, is often detected using these staining parameters.
As reported by the company, lifitegrast also significantly improved the most commonly reported symptoms of dry eye disease in the study, which were ocular discomfort and eye dryness. The mean ocular discomfort score and mean eye dryness score were lower in the lifitegrast group than in the placebo group at week 12 (P=0.0273 and P=0.0291, respectively). Lifitegrast was well tolerated and there were no unexpected or serious ocular adverse events. The most commonly reported ocular adverse events were irritation and pain upon initial instillation of lifitegrast, and were generally mild and transient in nature.
SARcode Bioscience recently commenced a year-long safety study (SONATA) and will soon begin a second pivotal Phase 3 confirmatory study (OPUS-2). Both studies will support a planned New Drug Application (NDA) filing.
Lens-On-Eye After Corneal Cross-linking By Boris Severinsky, MOptom, Jerusalem, Israel
These images show properly fitted silicone hydrogel mini-scleral Lens on the eye after corneal collagen cross-linking procedure. Please note fenestration holes that also act as stabilization marks.
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CARE SOLUTION CORNER Susan J. Gromacki, OD, MS, FAAO
The FDA and Guidance on Contact Lenses and Lens Care
The United States Food and Drug Administration (FDA) is in the process of publishing two papers1,2 outlining their activities since the contact lens-related Fusarium and Acanthamoeba keratitis outbreaks of 2006 and 2007, respectively. Ultimately, the FDA will propose new guidance for contact lens care products, which were last updated in 1997.
According to the papers, the FDA devised a research plan to:
Evaluate and better understand the properties of silicone hydrogel (SiHy) lenses
Develop "real world" scenario experiments with contact lenses and their care products
Conduct preservative depletion and efficacy studies
Develop Acanthamoeba test methods.
After silicone hydrogels were introduced in 1999, they were placed into the existing four lens care categories based on water content and ionic charge. However, they differed greatly from their predecessors in their degree of protein and lipid deposition, adsorption of surfactants, preservative uptake and release, and material properties. As a result, in 2009 the International Organization for Standardization (ISO) added a fifth group of lenses, the SiHys. Further study has led some FDA investigators to propose five sub-groups within the SiHy category to allow for their individual differences.
More to come on this topic in future columns.
1. Eydelman MB, Kiang T, Tarver ME, Alexander KY, Hutter JC. Preclinical Research to Aid in the Development of Test Methods for Contact Lenses and Their Care Products. Eye Contact Lens. 2012 Sep 17. [Epub ahead of print]
2. Eydelman MB, Tarver ME, Kiang T, Alexander KY, Hutter JC. The Food and Drug Administration's Role in Establishing and Maintaining Safeguards for Contact Lenses and Contact Lens Care Products. Eye Contact Lens. 2012 Sep 17. [Epub ahead of print].
OCULAR SURFACE UPDATE Katherine M. Mastrota, MS, OD, FAAO
Eyelid Margin Sensitivity
One of the more commonly used devices to measure corneal sensitivity is the Cochet-Bonnet handheld estesiometer. This pen-like device houses a fine retractable nylon monofilament that extends from 5mm to 60mm in length. As the length of the filament is decreased the pressure it exerts as it touched to the cornea increases (from 11 mm/gm to 200 mm/gm).
Interestingly, a recent study reported on the use of this device to measure eyelid margin sensitivity. The aim of this study was to characterize the eyelid margin and explore the relationships between lid margin sensitivity and staining, meibomian gland dysfunction, tear osmolarity, and ocular symptoms.
The authors concluded that there were clear clinical differences between lower and upper lids sensitivity with the lower lid being more sensitive. The study also demonstrated, for the first time, significant relationships between tear osmolarity and lid characteristics, including lid sensitivity. Lid margin staining was more frequent in lower than upper lids. Tear osmolarity correlated with upper-lid staining and lower-lid sensitivity. Increased sensitivity of the lower lid margin was associated with hyperosmolarity of the tear film, suggesting a nerve ending response to proinflammatory cytokines present in hyperosmolar tears. Lid sensitivity was also inversely correlated with meibomian gland dysfunction at the lower lid.
Golebiowski B, Chim K, So J, Jalbert I. Lid margins: sensitivity, staining, meibomian gland dysfunction, and symptoms. Optom Vis Sci. 2012 Oct;89(10):e1443-9.
Visual Performance of a Multifocal Toric Soft Contact Lens
The purpose of this study was to evaluate the visual performance of the Proclear multifocal toric contact lens (CL; CooperVision, U.S.) for both presbyopia and astigmatism correction.
In this crossover study design, 20 presbyopic subjects with astigmatism were fitted in a random order with either Proclear multifocal toric CL or Proclear toric single vision distance CL (DCL) combined with reading spectacles. After one month, high-contrast distance visual acuity, near high-contrast visual acuity, distance contrast sensitivity (CS) under photopic and mesopic conditions without and with glare, near CS, defocus curve, and stereopsis were measured. Subjects were then refitted with the alternative correction, and the procedure was repeated.
Repeated measures analysis of variance revealed differences in visual acuity and CS (p < 0.001) between groups were done. Mean binocular distance visual acuity and near visual acuity obtained with multifocal toric CL were -0.01 +/- 0.03 logMAR and -0.04 +/- 0.06 logMAR, respectively. The mean distance CS with the multifocal toric CL was within normal limits under photopic and mesopic conditions. Under photopic conditions, distant CS was better with distance CL than with multifocal toric CL only at 18 cycles/degree. Under mesopic conditions without and with glare, there were differences between both CLs in distant CS for all spatial frequencies. There were differences between the two CLs in near CS for all spatial frequencies. Mean values of stereopsis obtained with multifocal toric CLs and with the DCL combined with reading glasses were 62 +/- 12 sec of arc and 59 +/- 12 sec of arc, respectively (p = 0.06). Near range of clear vision with the multifocal toric CLs was 1.55 +/- 0.33D.
The authors concluded that the results of this study suggest that the multifocal toric CL studied is a good option to compensate both presbyopia and astigmatism, providing an optimal distance and near visual quality without compromising the stereopsis.
Madrid-Costa D, Tomas E, Ferrer-Blasco T, Garcia-Lazaro S, Montes-Mico R. Visual Performance of a Multifocal Toric Soft Contact Lens. Optom Vis Sci. 2012 Oct 2. [Epub ahead of print]