After an almost five year hiatus in new contact lens care systems, Bausch + Lomb introduced Biotrue multi-purpose solution in June. A product three years in the making, Biotrue was the result of B+L’s use of bio-inspiration (a discipline that studies and learns from nature’s best ideas) to generate three unique product features. According to B+L, the formulation:

• Matches the pH of healthy tears (7.5). Through the utilization of its buffers, sodium borate and boric acid, this ensures comfort upon insertion, minimal physiological change to the eye, optimal activation of the disinfectants, increasing antimicrobial efficacy.

• Utilizes hyaluronan (hyaluronic acid), a lubricant found in the eyes, to provide comfort

• Keeps certain beneficial proteins active, which maintains their antimicrobial properties

In addition, by utilizing the dual disinfection system of Polyhexamethylene biguanide (PHMB) and Polyquaternium-1 (PQ-1), Biotrue exceeds the FDA/ISO stand-alone tests for disinfecting products. And, following the FDA’s recent recommendations for contact lens care, B+L has labeled Biotrue as a rub-and-rinse regimen.

However, Biotrue is the first--but not the only--new product recently developed by industry. Follow this column to learn about the others in future issues.

For more information, please reference:
http://www.clspectrum.com/article.aspx?article=104447
http://www.clspectrum.com/supplement
.aspx?sn=specialed10&tm=3/31/2010
http://www.bausch.com/en_US/ecp/
visioncare/product/softcontacts
/biotrue_solution_ecp.aspx

At a recent conference, the topic of long-term topical steroid use for dry eye came up as an audience question: "Why wouldn’t you put a patient on one drop a day of a low dose steroid forever?" The concept of long term topical steroid use is discussion-worthy, and is certainly one of risk vs. benefit.

We know that daily topical application of steroid drops is used months to years following corneal transplant surgery to prevent graft rejection. What is the risk/ benefit ratio in this instance? Prevention of graft rejection arguably outweighs the risk of cataract and glaucoma development, both of which are carefully monitored in transplant patients.

So what about the risk/ benefit in dry eye? The practitioner pointed out that "patients feel better," which by any clinical standards is positive, but is there a significant negative? The practitioner countered with the discussion that "soft-steroids" have a reduced risk of IOP increases and cataract formation. According to package inserts, use of the drug for 10 days or longer requires monitoring of intraocular pressure. Package inserts also state that prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.

A risk/ benefit assessment and careful follow up are warranted in steroid use for dry eye, as is a long-term, well-controlled clinical study.

Voluntary Recall Expanded of Select Lots of 1•Day Acuvue TruEye Outside of U.S.

Johnson & Johnson Vision Care (J&J) is expanding its voluntary recall of 1•Day Acuvue TruEye (narafilcon A) Brand Contact Lenses to include additional lots. 1•Day Acuvue TruEye Brand Contact Lenses sold in the U.S. are made with a different material, narafilcon B, and are not affected by the recall.

This action follows the company's extensive review of its manufacturing process which identified the potential for some lenses to have higher than expected levels of a processing aid linked to previous complaints in which wearers described unusual stinging or pain upon insertion.

Nearly 75 percent of the affected product is in Japan, with limited distribution in countries within Europe and Asia Pacific, as well as Canada. Regulatory authorities in all countries with affected lot numbers listed are being notified.

In August, the company announced a voluntary recall of select lots of the lenses following a limited number of complaints. During the initial investigation, the company determined that the root cause of the complaints was linked to a processing aid intended to be removed during the lens rinsing process, which was present at higher than expected levels. In addition to the recall, shipments of product from the affected manufacturing lines were immediately suspended and the company conducted extensive product testing on its inventory of 1•Day Acuvue TruEye (narafilcon A).

This additional testing revealed some variability in the manufacturing rinsing process on these affected production lines that could potentially result in lenses having higher than expected levels of the processing aid, and identified a small percentage of contact lenses in the expanded lots that do not meet internal manufacturing requirements.

Continued complaint monitoring through its post market vigilance program indicates no increase in health-related complaints related to this product variation. 1•Day Acuvue TruEye (narafilcon A) will continue to be supplied via other manufacturing lines.

Alcon Board Elects New Chairman

The Alcon, Inc. board of directors elected Dr. Daniel Vasella as its Chairman of the Board, replacing Cary Rayment who had served as chairman since May 3, 2005. Dr. Vasella is also Chairman of the Board of Novartis AG, which became Alcon's majority owner after it purchased 52% of Alcon's shares from Nestle SA on August 25, 2010, bringing its total share ownership to approximately 76%. He has served on the board of Alcon since July 7, 2008. Mr. Rayment will remain on the board and will serve as its vice-chairman.

In a separate release issued by Alcon on behalf of the Alcon Independent Director Committee (IDC), the IDC noted that the composition and mandate of the IDC remains unchanged.

Thomas G. Plaskett, Chairman of the IDC, said, "Although Alcon has a new Chairman, nothing has changed with respect to the IDC. Alcon's Organizational Regulations clearly require the IDC's prior recommendation before the Alcon Board of Directors can decide on any transaction between Alcon and Novartis. The IDC will continue to take all available and appropriate actions to ensure that this process is upheld and that the rights of Alcon's minority shareholders are protected."

-- ADVERTISEMENT --

OAA Holds Annual Meeting

The Orthokeratology Academy of America held its annual meeting and educational conference, Vision By Design 2010, in Chicago with more than 250 attendees from 13 countries. Presentations covered a variety of topics including myopia control; corneal reshaping to correct severe myopia, hyperopia; presbyopia and high astigmatism; peripheral refraction; topographical analysis; the mechanism of Ortho-K; pediatric corneal reshaping; and crosslinking.

The general meeting was preceded by two full days of workshops and included a "bootcamp" for newcomers to corneal reshaping. Patrick Caroline was presented the "Excellence In Ortho-K" award, presented annually to an individual who has contributed significantly to the development of Ortho-K. Patrick Caroline and Earl Smith III also were awarded research fellowships for their contributions to the field of corneal reshaping.

Vision By Design 2011 will be held April 29-May 1 in Orlando, Fla. The three-day event will cover all topics of corneal reshaping and offer courses for both beginner and advanced orthokeratologists. "Boot Camp for Beginners" for both staff and doctors will be held on April 29. This meeting will include more than 10 hours of corneal reshaping education from the leading presenters in the field. For those wishing to sit for the OAA fellowship exam, preparatory courses and practical exams will be held at this meeting.

CLMA Elects New Board of Directors

At its recent annual meeting the Contact Lens Manufacturers Association (CLMA) elected their new officers and board of directors. The new officers are: President, Al Vaske, Lens Dynamics, Inc.; Vice President, Ken Leonhard, Quality Contact Lens, Inc.; Secretary-Treasurer, Jeff Duncan, Essilor USA, Inc. and Immediate Past President, Chris Pantle, DAC International, Inc.

Board members representing the Regular Membership of the CLMA include: Josh Adams, Valley Contax; Dan Bell, Corneal Design Corporation; Dan Bickers, Diversified Ophthalmics, Inc.; Keith Parker, Advanced Vision Technologies and Jan Svochak, Tru-Form Optics, Inc. The board members representing the Associate Membership of the CLMA are David Bland, Boston Products Group, Bausch + Lomb, Inc. and Tim Koch, Contamac US, Inc.

Global Specialty Lens Symposium, January 27-30, 2011, Paris Hotel & Casino in Las Vegas

Plan now to attend the Global Specialty Lens Symposium in January 2011. With an expert international faculty and a CE-accredited agenda, the 2011 GSLS will include insightful presentations by experts in the field, hands-on demonstrations of cutting-edge products as well as scientific papers and posters. Look for more detailed information in future issues of Contact Lens Spectrum and online at www.GSLSymposium.com.
--ADVERTISING

Last week’s Editor’s Commentary and Quick Poll were focused on various aspects of compliance. The abstract highlighted this week is also focuses on the same theme, but more specifically on patient perceptions of their own compliance with lens care relative to their knowledge of risk factors for complications. As highlighted, it appears that although many patients believe they are compliant, they are not. Although the abstract concludes that education alone is not sufficient to improve behavior, I wonder if we just aren’t doing our jobs in educating patients thoroughly enough.

Patient Compliance During Contact Lens Wear: Perceptions, Awareness, and Behavior

Patient noncompliance with recommended hygienic practices in contact lens wear is often considered a significant risk factor for microbial keratitis and adverse contact lens-related events. Despite advancements in lens materials and care solutions, noncompliant behavior continues to hinder efforts to maximize contact lens safety. The objective of this pilot study was to assess the relationship between perceived and actual compliance with awareness of risk and behavior.

One hundred sixty-two established contact lens wearers were sequentially evaluated after their routine contact lens examination at the Optometry Clinic at the University of Texas Southwestern Medical Center at Dallas, TX. Each patient was questioned by a single trained interviewer regarding his or her lens care practices and knowledge of risk factors associated with lens wear.

Eighty-six percent of patients believed they were compliant with lens wear and care practices; 14% identified themselves as noncompliant. Using a scoring model, 32% demonstrated good compliance, 44% exhibited average compliance, and 24% were noncompliant; age was a significant factor (P = 0.020). Only 34% of patients who perceived themselves as compliant exhibited a good level of compliance (P<0.001). Eighty percent of patients reported an awareness of risk factors, but awareness did not influence negative behavior. Replacing the lens case was the only behavior associated with a positive history for having experienced a prior contact lens-related complication (P = 0.002).

Perceived compliance is not an indicator for appropriate patient behavior. A large proportion of patients remain noncompliant despite awareness of risk. Education alone is not a sufficient strategy to improve behavior; newer approaches aimed at improving compliance with lens care practices are urgently needed.

Bui TH, Cavanagh HD, Robertson DM. Patient Compliance During Contact Lens Wear: Perceptions, Awareness, and Behavior. Eye Contact Lens. 2010 Oct 8.