One of the more interesting observations that has become of great clinical interest over the last 10 or more years has been that of lid wiper epitheliopathy. Although it is not fully understood, the lid wiper region is in opposition to the ocular surface and is thought to help spread the tears during a blink. It is also thought to be related to comfort of the eye, especially in contact lens wearers. While there is still much to be understood, I think it is critical that we watch for more developments of our understanding of the lid wiper, in both health and ocular surface disease.
Jason J. Nichols, OD, MPH, PhD
B+L Announces Platinum Sponsorship of the International Keratoconus Academy
Bausch + Lomb announced that its Specialty Vision Products business has renewed its platinum sponsorship of the International Keratoconus Academy for the second consecutive year. The organization, established in late 2014, promotes ongoing professional education and scientific development in the area of keratoconus and other forms of corneal ectasia. B+L Specialty Vision Products’ platinum sponsorship will continue to support these efforts, as part of its commitment to help meet the needs of patients with these challenging visual conditions.
B+L Specialty Vision Products is committed to furthering education and support, while fulfilling the growing needs of the GP market by providing ECPs finished contact lenses for serious optical conditions such as keratoconus, Pellucid Marginal Degeneration, and post-refractive surgery. Throughout the year, the business will be sponsoring numerous webinars and training sessions for expert specialty lens fitters, educating them on lens options for patients with these conditions.
NovaBay Pharmaceuticals, Inc. announces the appointment of Mark M. Sieczkarek as President and Chief Executive Officer, effectively immediately. Sieczkarek has been a NovaBay Director since January 2014, was named Chairman in April 2015 and has served as interim President and CEO since November 2015. He has been instrumental in the development and implementation of the go-to-market strategy for Avenova.
Sieczkarek previously was CEO of Solta Medical, Inc. (acquired by Valeant Pharmaceuticals) and of Conceptus, Inc. (acquired by Bayer HealthCare), where he led the launch of the medical device Essure. Prior to that, he was Senior Vice President and President of The Americas and Europe for Bausch & Lomb (acquired by Valeant Pharmaceuticals), where he was responsible for overseeing multinational commercial launches of several leading products.
The Educational Program Committee of the Global Specialty Lens Symposium invites the submission of abstracts for the Free Paper Section and the Scientific Poster Competition. Papers and posters related to presbyopia, keratoconus, corneal topography, post penetrating keratoplasty or related irregular corneal surface, myopia control, orthokeratology and lens care topics are welcome.
The GSLS will be held January 19-22, 2017 at The Rio Hotel in Las Vegas, Nevada. Visit www.GSLSymposium.com for more information. Web submissions only. Deadline for submissions is August 31, 2016.
Ocular Therapeutix Reports Topline Results for Dextenza Second Phase 3 Trial
Ocular Therapeutix, Inc. announced topline results from its second Phase 3 clinical trial to evaluate the safety and efficacy of Dextenza (sustained release dexamethasone) Intracanalicular Depot for the treatment of ocular itching associated with chronic allergic conjunctivitis. The single primary endpoint of the trial, defined as the difference in the mean scores in ocular itching between the treatment group and the placebo comparator group at three time points 7 days following insertion of the depots, was not achieved. While mean ocular itching was seen to be numerically lower (more favorable) in the Dextenza treatment group compared to the placebo group measured 7 days following insertion of the depots, at 3, 5, and 7 minutes by -0.18, -0.29, and -0.29 units, respectively, on a five point scale, this difference did not reach statistical significance. In addition, the trial did not achieve the requirement of at least a 0.5 unit difference at all three time points 7 days following insertion of the depots and at least a 1.0 unit difference at the majority of the three time points between the treatment group and the placebo group 7 days following insertion of the depots.
The trial also assessed conjunctival redness as a secondary endpoint. The differences in the mean scores in conjunctival redness between the Dextenza treatment group and the placebo group 7 days following insertion of the depots at 7, 15 and 20 minutes were -0.35, -0.39 and -0.42, respectively, compared with values of -0.26, -0.32 and -0.41, respectively, at the same time points 7 days following insertion of the depots in the first Phase 3 trial.
Ocular Therapeutix reported topline results of its first Phase 3 allergic conjunctivitis clinical trial with Dextenza in October 2015, where the primary endpoint for ocular itching associated with allergic conjunctivitis was successfully achieved and the primary endpoint for conjunctival redness was not achieved. The company is currently in the process of conducting a thorough analysis of the data from the second Phase 3 trial to fully understand the difference in efficacy between the two Phase 3 trials and plans to meet with the FDA to discuss the results and chart an appropriate path forward for the development of Dextenza for the treatment of allergic conjunctivitis.
The FDA has established specific refractive indications for the use of corneal reshaping contact lenses in the United States. One of the limitations is the amount of astigmatism. Practitioners tend to occasionally fit patients outside of the approved indications. The question in this case becomes, what is the potential outcome of fitting outside the approved limits for astigmatism?
A recent study was published that looked at the influence of corneal toricity on treatment zone positioning.1 Subjects were divided into a low toric group (less than or equal to 1.50D of corneal toricity – LoTor) and a high toric group (between 1.50 and 3.50D of corneal toricity – HiTor). In the LoTor group, 21 participants were fit using a conventional fitting approach based on the flat corneal meridian. In the HiTor group, 12 participants were fit using the conventional fitting method in one eye (HiTor group I) and the other eye was fitted with a lens with slightly deeper sagittal height (HiTor group II). In all groups, BE spherical orthokeratology trial contact lenses (Boston XO) were used and corneal topography data (Medmont E300) were obtained at baseline and after a single overnight wear. The magnitude of treatment zone decentration relative to vertex normal was determined from corneal topography refractive power difference maps. Treatment zone parameters including magnitude and direction of decentration were analyzed and related to baseline corneal parameters.
Outcomes found that after a single overnight wear, the mean magnitude of treatment zone decentration was 0.48 ± 0.20 mm in the LoTor group, 1.06 ± 0.57 mm in HiTor group I, and 0.95 ± 0.44 mm in HiTor group II. Treatment zone decentration in the LoTor group was significantly different from HiTor group I (p < 0.001), both fit using a conventional fitting method. Treatment zone decentration was not significantly different between HiTor group I and II (p = 0.606). The magnitude of treatment zone decentration was positively correlated with the amount of baseline corneal toricity (LoTor and HiTor group I combined, p = 0.048). The authors concluded that eyes with higher amounts of corneal toricity give rise to increased amounts of treatment zone decentration in overnight corneal reshaping.
Results from this study support fitting patients within approved guidelines in order to achieve the highest likelihood for successful outcomes. However, designs have been developed worldwide that can address issues such as higher degrees of corneal toricity. Over time we expect to see expansion of approved indications as technology continues to move forward.
1. Maseedupally VK, Gifford P, Lum E, Naidu R, Sidawi D, Wang B, Swarbrick HA. Treatment Zone Decentration During Orthokeratology on Eyes With Corneal Toricity. Optom Vis Sci. 2016 May 31. [Epub ahead of print].
OCULAR SURFACE UPDATE Katherine M. Mastrota, MS, OD, FAAO
Ocular Surface in Diabetic Children
It is generally accepted that diabetic patients are at risk for ocular surface disease. I would assume that in most practices that vast majority of diabetic patients are adults. What about the ocular surface in the pediatric diabetic population?
The ocular surface characteristics in a small pediatric cohort is reported in the May 2016 Current Eye Research.1 The authors studied tear film osmolarity, corneal epithelial thickness, conjunctival brush cytology, tear film break-up time, Schirmer test, meibography and OSDI in 26 diabetic children and 20 control children.
Of note, the study revealed significantly higher tear film osmolarity, lower Schirmer test scores and changes in conjunctival cytology in diabetic children. Tear film osmolarity levels were significantly associated with HbA1c levels. The authors suggest that altered ocular surface changes in diabetic children may be due to the result of increased tear film osmolarity.
In our day-to-day practice we should be cognizant of the fact that some our youngest patients may have risk factors for ocular surface disease and that simple point-of-care testing may be appropriate as part of their comprehensive ocular examinations.
1. Gunay M, Celik G, Yildiz E, Bardak H, Koc N, Kirmizibekmez H, Gunay BO, Yesiltepe Mutlu RG. Ocular Surface Characteristics in Diabetic Children. Curr Eye Res. 2016 May 9:1-6.
Some recent research has resulted in a hypothesis that there is a common 'lid wiper' region that is apposite to the ocular surface or anterior lens surface (where contact lenses are worn), responsible for spreading tears during blinking. In the upper eyelid, it extends about 0.6 mm from the crest of the sharp posterior (inner) lid border (i.e. the mucocutaneous junction, or line of Marx) to the subtarsal fold superiorly and from the medial upper punctum to the lateral canthus horizontally. Histologically, it is seen as an epithelial elevation comprising of stratified epithelium with a transitional conjunctival structure of (moving posteriorly) squamous cells then cuboidal cells, with some parakeratinised cells and goblet cells.
Lid wiper epitheliopathy (LWE) denotes staining of the lid wiper after instillation of dyes such as fluorescein, rose bengal or lissamine green. There have been some reports of higher rates of LWE in dry eye patients and contact lens wearers, but others have failed to find such associations. The primary cause of LWE is thought to be increased friction between the lid wiper and ocular or anterior contact lens surface due to inadequate lubrication, which could be caused by dry eye and may be exacerbated by factors such as abnormal blinking patterns, poor contact lens surface lubricity and adverse environmental influences. Recent evidence suggests that LWE is associated with sub-clinical inflammation. LWE has the potential to provide the missing mechanistic link between clinical observation and symptoms associated with dry eye and contact lens wear. Clinical and fundamental research into LWE is still in its infancy and in many instances equivocal; however, it is an idea that provides a potentially important new avenue for further investigation of anterior eye discomfort associated with ocular dryness and contact lens wear.
Efron N, Brennan NA, Morgan PB, Wilson T. Lid wiper epitheliopathy. Prog Retin Eye Res. 2016 Apr 14. pii: S1350-9462(16)30013-1. doi: 10.1016/j.preteyeres.2016.04.004. [Epub ahead of print]