In the JournalsPerspective

Antihistamine delivery via contact lens shown to be effective

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.

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.

    Perspective
    Kerry Giedd

    Kerry Giedd

    The benefits of using a contact lens as a vehicle for drug delivery have been discussed for many years, and numerous studies have been published on this concept. Yet, despite the interest in and potential of such products, they have been slow to come to market. Time will tell if this Johnson & Johnson-sponsored study leads to a product we can reach for in our practices, but these results are promising and offer hope for a welcome new strategy to help manage ocular allergy symptoms for millions of patients.

    Ketotifen, the antihistamine available in over-the-counter eye drops such as Zaditor (Novartis) and Alaway (Bausch + Lomb), has a well-established history, and its efficacy as it relates to ocular itching was affirmed in this study, as well. If Johnson & Johnson — or any company — is going to be successful in bringing an antihistamine-releasing contact lens to market, using a nonprescription drug may ease some of the regulatory, accessibility and other challenges that the manufacturer, eye care providers, retailers and patients would face compared to if a prescription agent was used. So, while there may be more efficacious antihistamines available by prescription, the choice to use ketotifen is presumably the most practical in the marketplace, at least as a first available option.

    In proposed contact lens delivery models with other drug classes (glaucoma medications, etc.) in other studies, the therapeutic treatment and related benefits, such as improved compliance, are more likely to drive contact lens wear vs. contact lens wear truly being a desired goal. The opposite is likely to be true for a product such as in the above-referenced study, as it provides a mechanism to optimize our existing contact lens patients’ experience. That, for many ECPs, will make this product easy to adopt in practice, since we are so often challenged to bring satisfactory relief of allergic conjunctivitis to our existing contact lens wearers, who are unable to use topical medications while wearing their lenses.

    • Kerry Giedd, OD, MS, FAAO
    • Primary Care Optometry News Editorial Board Member

    Disclosures: Giedd reports she is a consultant to Bausch + Lomb