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Clinicians link contact lens-associated infiltrative keratitis to contact lens solution
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Two eye care professionals have seen a spike in non-infectious focal corneal infiltrates associated with a leading contact lens solution.
In an interview with Ocular Surgery News, Neal A. Sher, MD, FACS, said he and Jason Jedlicka, OD, have reported more than 35 cases that meet the criteria for contact lens-associated infiltrative keratitis (CLAIK) associated with Opti-Free Replenish (Alcon).
“We probably started seeing it in 2008 or 2009. It wasn’t clear what it was from,” Sher said. “We weren’t sure what we were seeing, and we didn’t necessarily associate it with one particular contact lens solution. … Certainly in the last 3 years we started seeing these cases. In the last year or two, we noticed that it was associated with Opti-Free Replenish.”
Sher said he notified Alcon about the cases but received a “noncommittal” response from the company. He and Jedlicka subsequently reported the cases to the U.S. Food and Drug Administration.
In May, the FDA received an adverse event report related to eye injury sustained by a patient using the contact lens solution. The patient was diagnosed with inflammation, punctate keratitis, infiltrates and mild edema.
The adverse event resolved with antibiotic and steroid treatment, the report said. Alcon was unable to review product safety records because the adverse event report did not include a product lot number or any identification traceable to manufacturer documentation, according to the report.
Sher said the infiltrates are multifocal and scattered mainly in the epithelial and subepithelial layers.
“They’re infiltrates. They’re not superficial punctate keratitis. They’re not marginal. They’re not isolated single infiltrates or ulcers. They’re not infectious. We ruled out other things,” he said.
All cases responded to antibiotic or antibiotic-steroid treatment, and none developed permanent vision loss or significant permanent scarring, Sher said.
“We postulate that the Opti-Free Replenish does not kill certain bacteria at the kill rate of other solutions,” he said. For example, cultures showed that the solution did not kill various bacteria such as the Achromobacter species.
According to Sher, Joseph P. Shovlin, OD, suggested that bacteria may be producing a biofilm that is causing an immune reaction.
“What we’re seeing is basically an immune type of focal keratitis,” Sher said. “It makes sense from a mechanism point of view.”
Ophthalmic literature on CLAIK associated with Opti-Free Replenish is scant, Sher said.
“There have been some articles and research, mostly in the optometric literature, but very little in ophthalmology,” he said.
In an upcoming issue, OSN will publish a more detailed article about the CLAIK cases.
Article updated: September 5, 2012.
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Disclosure: Sher has no relevant financial disclosures.