A study published in Cornea showed that the ocular antihistamine ketotifen was effectively delivered via a contact lens also designed for visual correction.
Currently available topical antiallergic medications are comparable to this contact lens delivery method in efficacy, the authors said; however, they require that an individual removes his or her contact lenses prior to application.
“This is, in part, because of concerns regarding interactions between lenses and drop preservatives and also because clinical studies of allergy drops have typically excluded contact lens users from study populations,” the authors wrote. “Without data to establish compatibility, regulatory guidelines emphasize that drops should not be used while wearing lenses.”
This study represents the cumulative results of two multicenter, randomized, placebo-controlled trials. Researchers divided the 244 participants into three groups; group 1 received the test lens, etafilcon A with 0.019 mg ketotifen, and a control lens in the contralateral eye. Group 2 received test lenses in both eyes. Group 3 received control lenses in both eyes.
On two separate visits, researchers initiated a 15-minute onset challenge after lens insertion and a 12-hour challenge to test its duration. According to the study, ocular itching measured on a 0 to 4 scale, in half-unit steps, was the primary endpoint. Ciliary, conjunctival and episcleral hyperemia were the secondary endpoints.
Researchers observed that mean itching scores were lower for participant eyes wearing the test lens when compared to results from the control lens. The ocular itching results were comparable to that of a direct topical drug delivery method.
“These phase 3 study results are important on multiple fronts,” Brian Pall, OD, MS, FAAO, director of clinical science at Johnson & Johnson Vision Care Inc. and lead author of this study, said in a press release from the company. “Contact lens wearers who historically suffer from itchy, allergy eyes had meaningful reductions in itching across two randomized, well-controlled studies. There was both a clinically and statistically significant reduction in ocular itching that occurred 15 minutes after lens insertion and lasted for the 12-hour study evaluation period. This marks the first time that contact lens technology has shown potential in a large-scale study to address itch stemming from ocular allergies.”
Both studies reached the primary endpoint, respectively, in both the 15-minute and 12-hour challenges. Researchers stated that the addition of antihistamine ketotifen into the contact lens solution showed no structural, optical or refractive effects on the lens and, overall, was well tolerated by participants.
“It is encouraging to see this large-scale assessment that indicates the potential of a contact lens-based drug delivery system, which, in the future, could represent an entirely new category of contact lenses,” Xiao-Yu Song, PhD, MD, J&J Vision Care global head of research and development, said in the release. “We will continue development of this contact lens technology and are committed to making regulatory submissions for this antihistamine-releasing contact lens as we move forward.” – by Scott Buzby
Disclosure: This study was funded by Johnson & Johnson Vision. Pall and Song are employed by J&J Vision.