Administrative Law Judge Upholds FTC’s Complaint Against 1-800 Contacts
In an Initial Decision announced recently, Chief Administrative Law Judge D. Michael Chappell upheld a Federal Trade Commission (FTC) complaint against 1-800 Contacts. According to the FTC’s administrative complaint, 1-800 Contacts entered into bidding agreements with at least 14 competing online contact lens retailers that eliminated competition in auctions to place advertisements on the search results page generated by online search engines such as Google and Bing. The complaint alleges that these bidding agreements constituted an unfair method of competition, in violation of federal law, by unreasonably suppressing price competition in certain online search advertising auctions and restricting truthful and non-misleading advertising to consumers. As a result, some consumers paid higher retail prices for contact lenses, the complaint stated.
An order Judge Chappell included with the Oct. 20, 2017 Initial Decision would bar 1-800 Contacts from agreeing with a marketer or seller of any contact lens product to restrict, prohibit, regulate, or otherwise limit that seller’s participation in search advertising auctions. It would also bar 1-800 Contacts from instructing search engines to restrict or prohibit any seller’s use of any keyword (a word or phrase used to instruct a search engine to display specified search advertising) or to require any seller to use any negative keyword (a word or phrase used to instruct a search engine not to display specified search advertising).
Also under the order, 1-800 Contacts would be barred from agreeing with a seller to restrict, prohibit, regulate, or otherwise limit that seller’s use of truthful, non-deceptive, and non-trademark-infringing advertising or promotion. The order would further require the company to stop enforcing or attempting to enforce any and all provisions, terms, or requirements in any existing agreement or court order that impose a condition on a seller that would be inconsistent with the order. The Initial Decision will become the decision of the Commission 30 days after it is served upon the parties, unless a party files a timely notice of appeal—and thereafter files a timely appeal brief—or the Commission places the case on its own docket for review or stays the effective date of the decision.
Bausch + Lomb and Nicox Announce FDA Approval of Vyzulta
Valeant Pharmaceuticals International, Inc.’s wholly owned subsidiary, Bausch + Lomb, and Nicox S.A., an international ophthalmic company, announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%). Vyzulta, the first prostaglandin analog with one of its metabolites being nitric oxide (NO), is indicated for the reduction of intraocular pressure (IOP) in patients who have open-angle glaucoma or ocular hypertension.
Following topical administration, Vyzulta, a once-daily monotherapy with a dual mechanism of action, works by metabolizing into two moieties, latanoprost acid, which primarily works within the uveoscleral pathway to increase aqueous humor outflow, and butanediol mononitrate, which releases NO to increase outflow through the trabecular meshwork and Schlemm's canal. The most common ocular adverse events include conjunctival hyperemia, eye irritation, eye pain and instillation site pain. Increased pigmentation of the iris and periorbital tissue and growth of eyelashes can occur.
Vyzulta was licensed on a global basis to Bausch + Lomb from Nicox. As a result of this approval, Nicox will receive $17.5 million from Bausch + Lomb and will make a $15 million payment to Pfizer under a previous license agreement.
Novaliq’s NovaTears Launches in New Zealand, Receives Registrational Approval in Australia
Novaliq GmbH launched NovaTears, a water-free topical eye drop treatment specifically developed to treat patients who have dry eye disease, in New Zealand and received registrational approval in Australia. In March 2017, Novaliq and AFT Pharmaceuticals (AFT) signed an exclusive licensing partnership agreement for the commercialization of NovaTears across Australasia. AFT, a New Zealand-based pharmaceutical, will commercialize NovaTears.
Revisions to ISO’s Optics and Ophthalmic Optics Standards
The International Organization for Standardization (ISO) announced revisions to several of its ophthalmic optics standards that relate to contact lenses.
* ISO 18369-1:2017 - Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications identifies and defines the terms applicable to the physical, chemical, and optical properties of contact lenses, their manufacture, and uses. It provides a vocabulary of terms and, when appropriate, the international symbol and abbreviation associated with a specific term.
* ISO 18369-2:2017 - Ophthalmic optics - Contact lenses - Part 2: Tolerances specifies the tolerance limits of the principal optical and physical parameters of rigid corneal, rigid scleral, and soft contact lenses at the time of manufacture.
* ISO 18369-3:2017 - Ophthalmic optics - Contact lenses - Part 3: Measurement methods specifies the methods for measuring the physical and optical properties of contact lenses specified in ISO 18369-2 (i.e., radius of curvature, label back-vertex power, diameter, thickness, inspection of edges, inclusions and surface imperfections, and determination of spectral transmittance). This document also specifies the equilibrating solution and standard saline solution for testing of contact lenses.
* ISO 18369-4:2017 - Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials specifies the methods of testing the physicochemical properties of contact lens materials. These are extraction, rigid lens flexure and breakage, oxygen permeability, refractive index, and water content.
B+L Announces FDA Filing of Extended Wear Indication for B+L Ultra Lenses
Bausch + Lomb (B+L) has filed a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA) to clear Bausch + Lomb Ultra contact lenses for extended wear. If cleared, B+L Ultra contact lenses would be indicated for up to seven days of continuous wear.
Bausch + Lomb fielded a 12-month, controlled, parallel group, masked, randomized study at 34 sites across the United States. The objective was to evaluate the safety and effectiveness of the samfilcon A soft (hydrophilic) contact lens, a silicone hydrogel contact lens, when worn for seven-day extended wear by adapted soft contact lens wearers. The clinical study was submitted to the FDA as part of the PMA filing.
The lenses feature polyvinylpyrrolidone (PVP) for enhanced wettability and have a Dk/t of 163 and a modulus of 70. The lens also incorporates aspheric optics and spherical aberration control. Bausch + Lomb Ultra contact lenses are also available for patients who have astigmatism and presbyopia.
International Forum for Scleral Lens Research to Be Held in December
The IFSLR is an open meeting in which practitioners and laboratories interested in the latest developments and evidence-based information are invited to attend. The 2017 program will cover topics such as corneo-limbal anatomy, scleral lens design, wavefront-guided scleral lenses, corneal hypoxia, and intraocular pressure and glaucoma with scleral lens wear. This meeting is sponsored by Bausch + Lomb, Contamac, Essilor, Blanchard, Metro Optics, SynergEyes, TruForm, Tangible Science, Art Optical, and BostonSight.
New Independent Alliance Forms to Support Eyecare Professionals
Nautic Partners, LLC has created Healthy Eyes Advantage (a.k.a., Healthy Eyes or HEA) in partnership with four industry leading companies to form the largest alliance of eyecare professionals (ECPs) in the country, according to Nautic. Healthy Eyes has acquired substantially all of the assets of Block Buying Group (BBG); C&E Vision Services (C&E); HMI, including Red Tray and Club Zero; and Vision West. Together, Healthy Eyes will serve more than 10,000 independent ECPs.
Nautic says that the newly formed Healthy Eyes alliance will offer new and unparalleled access, services, education, and networking to independent optometrists, ophthalmologists, and opticians. As the largest alliance in the country, HEA will set the standard of independent community and network services offered to the industry.
The HEA team includes Jeff Rinkus, the former COO of ABB Optical; Andrew Alcorn, the former CEO of Block Vision and chairman of Superior Vision; and Dr. Joe Mallinger, former CEO of Vision West, past president of the California Optometric Association, and president-elect of Optometry Cares, the American Optometric Association’s Charitable Foundation. In addition to the executive team, Michael Block, founder and CEO of BBG and pioneer of the eyecare buying group industry; and Brad Shapiro, principal of C&E and Vision West, have joined the board of Healthy Eyes and are serving as senior advisors to the company. The company is based in Boca Raton, FL with offices in San Clemente, CA; San Diego; and Vicksburg, MS.
What do you believe is the most common cause of contact lens discomfort in your contact lens wearers?
This image shows a custom octa-curve (eight curves) bi-toric reverse geometry contact lens for orthokeratology. The patient’s right eye refraction is +1.75 -3.75 x 5°. For the last six years, he used a traditional esa-curve (six curves) toric reverse geometry lens. (Note: both of these are custom lenses that I designed that are manufactured by a laboratory in Italy). With this lens, the right eye visual acuity (VA) was < 20/40 0.5 during the daytime and was +1.50 –1.50 x 0°. Now his VA is 20/20- 1.0- during over-refraction with the lens in-situ. He also has similar vision between the right eye (treated) and the left eye (untreated +0.25 –0.50 x 0°).
We thank Nicola Sammarco for this image and 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 a detailed explanation of the photo and your full name, degree or title, and city/state/country.
CARE SOLUTION CORNER
Andrew D. Pucker, OD, PhD
Disinfecting Trial Contact Lenses
Diagnostically fitting a specialty contact lens is often one of the most interesting aspects of being a contact lens practitioner because you get the opportunity to use innovative contact lens designs while treating challenging cases. While, ideally, you would use each trial contact lens only once,1 many practitioners frequently work from fitting sets in which each contact lens is used multiple times and is sometimes stored for long periods of time between uses—a practice that has the potential to result in microbial contamination.2
The literature contains conflicting suggestions on how to best disinfect trial contact lenses. Specifically, Tyhurst and Hettler suggest that both soft and GP diagnostic contact lenses should be simply disinfected with a hydrogen peroxide care system after use.3
However, Lian et al suggest a more systematic approach for disinfecting trial contact lenses. They suggest that GP contact lenses should be immediately decontaminated (not allowed to dry) by first rinsing them with saline for 30 seconds, cleaning them with an approved GP contact lens cleaner, soaking them in 3.0% hydrogen peroxide for at least three hours, rinsing them with saline, drying them, and storing them dry in a clean container.1 The authors also suggest that the GP lenses should be cleaned again before the next use.1
Lian et al further suggest that soft contact lenses should be immediately cleaned with a soft contact lens cleaner, rinsed with saline, stored in a glass vial with sterile saline, and autoclaved.1 In addition, they suggest that trial contact lens cases should also be regularly disinfected with either hydrogen peroxide or by autoclaving;1 this disinfection step is also key for avoiding potentially harmful biofilms.4 Lastly, if a diagnostic contact lens has potentially come in contact with infectious disease, it should be discarded.1
Properly working with trial contact lenses can only be accomplished by first educating all staff and practitioners within an office about the importance of properly disinfecting trial contact lenses.4 To ensure patient safety, you should also develop standard operating procedures for cleaning trial lenses so that those lenses are properly handled each time.4
1. Lian KY, Napper G, Stapleton FJ, Kiely PM. Infection Control Guidelines for Optometrists 2016. Clin Exp Optom. 2017 Jul;100:341-356.
2. Farris RL. Is Your Office Safe? No. Cornea. 1990;9(Suppl 1):S44-S46; discussion S47.
3. Tyhurst KN, Hettler DL. Infection Control Guidelines--an Update for the Optometric Practice. Optometry. 2009 Nov;80:613-620.
4. Callender MG, Charles AM, Chalmers RL. Effect of Storage Time with Different Lens Care Systems on in-Office Hydrogel Trial Lens Disinfection Efficacy: A Multi-Center Study. Optom Vis Sci. 1992 Sep;69:678-684.
MATERIALS & DESIGNS
David L. Kading, OD
When It’s That Simple
Fitting contact lenses on patients has seemingly become second nature for most of us—especially when dealing with spherical or low-cylinder patients. This holds true even for multifocals for most patients. Indeed, an expert is someone who can make something complex look easy.
However, the reality is that there are many factors that we consider when selecting a lens for a new patient or when deciding to switch a patient from one lens to another. But what compels us to stay with the current lens? I actually find this to be one of the most complex decisions, especially when there are so many great lenses coming onto the market.
If a patient comes in with no complaints, it is still necessary for us to try to suss out any problems our patients may be having. As the saying goes: You don’t know what you don’t know. For instance, some patients may think that dryness at the end of the day is normal. Or, some may believe that because they work on a computer, their lenses are just going to fail them. Others may think that their vision is as good as it can get. It is imperative for us to try to find those "problems."
When patients are in the best lenses possible, are happy with their vision (and that vision cannot get any better), and their comfort is as good at the end of the day as at the beginning, then we have hit the jackpot. When this happens, it is just that simple…keep your patients in their current lenses.
Study of the Effectiveness of Multipurpose Solutions on the Bacterial Disinfection of Silicone Hydrogel Contact Lenses In Vitro
The purpose of this study was to assess the antimicrobial effectiveness of multipurpose solutions in regard to the disinfection of silicone hydrogel contact lenses (CLs) using a study of clinical bacterial isolates from ocular material.
Three multipurpose solutions (solution A: polyhexamethylene biguanide 0.00025g/100mL; solution B: polyquaternary-1 [sic] 0.001% and myristamidopropyl dimethylamine 0.0006%; and solution C: polyaminopropyl biguanide 0.00013% and polyquaternary [sic] 0.0001%) were used as a three-phase disinfection on silicone hydrogel CLs contaminated with bacteria from clinical isolates that were divided into five groups (group 1: Pseudomonas aeruginosa; group 2: Staphylococcus aureus; group 3: Staphylococcus epidermidis; group 4: Streptococcus spp; and group 5: enterobacteria).
The authors observed no differences between the 24- and 48-hour measurements in any of the samples, and the positivity of microorganisms in T0 was 100% for all solutions; it was 0% in T3. Therefore, only steps T1 (rubbing followed by rinsing) and T2 (rubbing followed by rinsing and immersion of CLs into solution) were considered for analysis at the 24-hour measurement time. Throughout the phases, a decrease in the number of bacteria was observed, culminating in the elimination (no recovery) of all microorganisms in the three solutions. At the end of the proposed process, the tested solutions were effective.
Correa PC, Lui ACF, Silva CB, Gracitelli CPB, Mimica LM, Sasagawa SM, Netto AL. Study of the Effectiveness of Multipurpose Solutions on the Bacterial Disinfection of Silicone Hydrogel Contact Lenses In Vitro. Eye Contact Lens. 2017 Oct 12. [Epub ahead of print]