Bausch & Lomb has settled a lawsuit with Alcon Inc. after the latter company agreed to alter its promotional use of a controversial corneal staining grid. The grid is based on Alcon-funded studies that the optometrist says show that certain contact lenses react with certain solutions to cause varying degrees of superficial punctuate transient corneal staining. Bausch & Lomb, whose solutions and lenses did not fare well comparatively, protested that most corneal staining in the study is transient and clinically insignificant.
Bausch & Lomb has settled a lawsuit with Alcon Inc. after the latter company agreed to alter its promotional use of a controversial corneal staining grid. (See Ophthalmology Times, July 15, 2007, Pages 6 and 8.)
The grid, devised by a Columbus, OH-based optometrist, is based on Alcon-funded studies that the optometrist says show that certain contact lenses react with certain solutions to cause varying degrees of superficial punctuate transient corneal staining. Alcon used the chart in a wide variety of promotional materials in practitioner offices and at trade shows.
Bausch & Lomb, whose solutions and lenses did not fare well comparatively, protested that most corneal staining in the study is transient and clinically insignificant. The company filed a lawsuit June 26 in U.S. District Court for the Western District of New York, charging that the rating system constitutes false and misleading advertising. The lawsuit sought unspecified damages for lost sales and corrective advertising. It was dismissed in August with prejudice, without any payment of damages from either party.
Gary Andrasko, OD, based the chart on ongoing studies pairing various brands of contact lenses and multipurpose solutions. According to colors used on the chart, green indicates lens/solution combinations where less than 10% of the cornea is stained; yellow combinations indicate that 10% to 20% is stained and should be monitored closely; and red combinations indicate that more than 20% is stained. Red combinations indicate "widespread staining" and mean that physicians should consider changing solutions.
Under the settlement agreement, Alcon will change the chart's red and yellow colors to something different but will continue to support the studies and sponsor continuing research, said Kathleen Golden, manager, corporate communications, Alcon.
According to the chart, which can be viewed at http://www.staininggrid.com/, the most staining (76%) occurs when silicone hydrogel lenses (PureVision, Bausch & Lomb) are used with a branded multipurpose solution (Target), which was identified as a version of a multipurpose contact lens disinfecting solution (ReNu MultiPlus, Bausch & Lomb). That result is followed closely by the combination of silicone hydrogel lenses, lenses with the contact lens solution (73%) and hydrogel lenses (SofLens 66, Bausch & Lomb) with the contact lens solution (also 73%), and another branded multipurpose solution (Wal-Mart), also identified as the contact lens solution (71%).
In an interview with Ophthalmology Times, Dr. Andrasko said he developed the chart for eye-care practitioners to determine the biocompatibility of contact lenses and multipurpose solutions. He said he believes corneal staining occurs as solution preservatives (chemical keratitis) are released on the eye. He noted on the chart that the Bausch & Lomb solutions with the highest rates of staining were made with biguanide preservatives.
"I don't believe when you have 70% of the cornea covered by micropunctate staining, that's insignificant-especially when there are solutions that easily could be substituted and get less than 10% of the cornea covered by staining," Dr. Andrasko said. "Why use a contact lens solution that causes a high amount of staining when you could use another one that causes very little staining?"
He said that patients also reported comfort decreased as staining increased and, as wearing time increased, comfort decreased if significant staining area existed.
Christopher Snyder, OD, MS, Bausch & Lomb's director of professional relations for the lens care/over-the-counter product portfolio, disputed Dr. Andrasko's research and said it is "inconsistent with my clinical experience."
"That is not validated by any clinical outcomes to date," Dr. Snyder said. "Clinical results with real patients do not validate that there are any problems with those lens-care products when really used with PureVision lenses or other silicone hydrogel lenses in the real world."
Dr. Snyder said the chart causes physicians to feel alarmed that they have been missing some significant problem in their patients, when all of the corneal staining described in the chart is clinically acceptable.