Return to rub-required regimen?

The upswing of two rare eye infections among soft contact lens wearers within the past 2 years is leading some professionals in the contact lens community to reconsider trends that emphasized comfort, perhaps at the expense of efficacy. Ophthalmologists, manufacturers, and industry analysts are predicting a return to “rub-required” cleaning regimens or hydrogen peroxide cleaning solutions that require more steps but might be more effective.

“There’s no doubt in my mind that lenses are cleaned better if they’re rubbed, and if those patients with Fusarium [keratitis] a year ago or Acanthamoeba [keratitis] more recently had digitally rubbed their lenses-old style, if you will-chances are, they would not have had this issue,” said Jeffrey D. Johnson, OD, senior research analyst with Robert W. Baird & Co.

As Advanced Medical Optics (AMO) considers options following the May 25 voluntary global recall of its multipurpose contact lens solution (Complete MoisturePlus) and an outbreak of Acanthamoeba keratitis cases among contact lens wearers, company officials said they would move away from “no rub” claims (Ophthalmology Times, June 15, 2007, Pages 1, 8, and 10). No evidence suggests that the voluntary recall is related to a product contamination issue, according to AMO. Company officials are working with the Centers for Disease Control and Prevention (CDC), FDA, and others; investigators continue to seek the source of Acanthamoeba keratitis among contact lens wearers.

“In light of recent developments and in an effort to encourage best practices, we will emphasize going forward that rubbing promotes the most thorough level of lens cleaning and disinfecting and is therefore in the best interest of all contact lens wearers,” said James V. Mazzo, AMO’s chairman, president, and chief executive officer, in a June 5 conference call. “The industry has been grappling for years to balance efficacy, comfort, and convenience. … Our expectation is that the Acanthamoeba keratitis issue will accelerate the pendulum shift away from convenience and back toward efficacy.”

The recall of AMO’s contact lens solution came 1 year and 10 days after Bausch & Lomb recalled its multipurpose contact lens solution (ReNu with MoistureLoc) as last spring’s outbreak of Fusarium keratitis was associated with use of the contact lens cleaning solution and common suboptimal hygiene practices (JAMA 2006;296:953-963).

In the more recent AMO case, 138 patients in 35 states and Puerto Rico tested positive for Acanthamoeba keratitis since Jan. 1, 2005, according to the CDC. A preliminary analysis by the CDC revealed that patients with the infection who used soft contact lenses were at least seven times more likely to have used AMO’s solution compared with a group of healthy adult soft contact lens wearers.

A care continuum

Contact lens wearers in the 1970s and 1980s relied on heat to clean their lenses before turning to multi-bottle hydrogen peroxide systems that were simplified to a single-bottle hydrogen peroxide regimen. Those who failed to neutralize their peroxide with a platinum disk or tablet, however, experienced a painful corneal burn, Dr. Johnson explained.

Still searching for easier and more comfortable cleaning methods, manufacturers began producing single-bottle multipurpose solutions that required patients to rub their lenses for 10 seconds before dropping them into their cases. That gave way to “no rub required” solutions in the past 5 to 10 years, said William H. Ehlers, MD, president of the Contact Lens Association of Ophthalmologists.

“Over the [past] 30 years, there’s been a continuum of trying to get more and more convenient and more and more comfortable,” Dr. Johnson said. “I question whether we tipped the scales of going too far in that continuum.”

Rub advised anyway

Although the FDA approved the “no rub” claims, many ophthalmologists advised patients to continue rubbing their lenses clean briefly anyway.

“Even though it may not seem like you’re doing a lot, when you take a few seconds a day to debride the surface of the lens digitally, you’re removing the deposits inherent to the lens and rinsing it before disinfecting it,” said Thomas L. Steinemann, MD, associate professor of ophthalmology at the Case Western Reserve University School of Medicine, Cleveland, staff ophthalmologist at MetroHealth Medical Center, Cleveland, and spokesman for the American Academy of Ophthalmology.

“We teach with analogies to our patients,” Dr. Steinemann said. “If you just finished dinner and you had a casserole or spaghetti, chances are most of us are going to scrape and rinse [our plates] before putting them into the dishwasher. You want to get the deposits off before putting it into the case.”

Dr. Ehlers said lens-care manufacturers’ emphasis on convenience and comfort was not inherently wrong, because patients were generally more compliant with these easier systems. Still, he encourages patients to rub their lenses.

AMO’s Mazzo announced last month that the company expects to see the market turn to increased use of hydrogen peroxide solutions, which were a “major topic of discussion” at the British Contact Lens Association meeting recently.

In a June 26 conference call with investors, AMO announced plans to relaunch an existing multipurpose solution with a proven track record that has been sold globally and in “targeted” areas of the United States. The product will be repackaged with a “rub-and-rinse” regimen on the label. Production at the company’s facilities in Spain and China is under way in preparation of a launch later this year, according to the company.

“Our market research indicates the Complete name carries significant brand equity, so we’ll leverage that with packaging and labeling instructions that accentuate the importance of proper contact lens handling,” said Randy Meier, AMO’s chief financial officer, chief operating officer, and head of the eyecare division. In addition, Meier said the company would increase its focus on its hydrogen peroxide product line.

AMO makes several hydrogen peroxide products, including a sterile 3% hydrogen peroxide solution for lens disinfection (UltraCare). The solution comes with neutralizing tablets and a vitamin B₁₂ color indicator that is added at the beginning of the disinfection cycle and colors the solution pink to show that the tablet has been added. The system also requires a specially designed lens cup for proper disinfection, neutralization, and storage. The company also markets a hydrogen peroxide solution in Europe (Oxystep 1 Step).

Dr. Ehlers cautioned, however, that he was not aware of any studies proving that hydrogen peroxide solutions are more efficacious than multipurpose solutions. He also noted that if multipurpose solutions were to blame for these two “quirky outbreaks,” then there should be a “huge increase” in infections nationally.

“The overall rate [of infections] has not changed significantly,” Dr. Ehlers said. “It’s important to remember that, with more than 30 million contact lens wearers in the United States, these are all relatively rare events. Obviously, if you’re one of the individuals with these problems, it’s huge and can be a life-changing event, so we certainly want to do everything we can to reduce the risk of wearing lenses.”OT