Johnson & Johnson Vision announced that results from two phase 3 clinical studies evaluating the company’s investigational antihistamine-releasing contact lens (etafilcon A with 0.019 mg ketotifen) were published in the journal Cornea. The results demonstrated that patients wearing the investigational contact lens had lower mean itching scores after their eyes were exposed to allergens compared to those wearing non-medicated control lenses, indicating that in these studies, the lenses reduced symptoms of eye itch.
“These phase 3 study results are important on multiple fronts. Contact lens wearers who historically suffer from itchy, allergy eyes had meaningful reductions in itching across two randomized, well-controlled studies,” Brian Pall, OD, MS, FAAO, Director, Clinical Science, Johnson & Johnson Vision Care, and lead author of the manuscript, said in a company news release. “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.”
According to the Cornea publication, more than 20 percent of the U.S. population experience ocular allergy, or itchy eyes, when exposed to allergens such as tree or grass pollen, pet dander or dust. The condition has a similar prevalence worldwide and can have a significant impact on productivity and quality of life.
“At Johnson & Johnson Vision, we are committed to pioneering new technologies that both correct people’s vision and also have potential to address other lifestyle or medical needs they may have,” Xiao-Yu Song, PhD, MD, Global Head of Research and Development, Johnson & Johnson Vision Care, said in a company news release. “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. 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.”
Study Design and Results
The antihistamine-releasing contact lenses worn in the studies are daily disposable lenses containing ketotifen, a drug that inhibits certain substances in the body that are known to cause allergic reactions and inflammation. They were tested in two multicenter, double-masked, randomized, placebo-controlled trials that included 244 patients and used the conjunctival allergen challenge model (Ora-CAC) to measure efficacy.
After the initial screening visits, patients were randomized by eye to receive either the antihistamine-releasing lens or the placebo control lens. The lenses were then worn for either 15 minutes or 12 hours depending on the study visit. After the prescribed wearing time, allergens were dosed into the eyes wearing the contact lenses and the patients reported the severity of their itching symptoms using a 0-4 scale (where 0 equals no itch and 4 equals an incapacitating itch with an irresistible urge to rub).
The primary study endpoint was comparisons of reported itching scores between the two lens types. Across both studies, the patients who wore the antihistamine-releasing contact lenses experienced both a clinically and statistically significant (P< 0.001) reduction in the average eye itch symptom at both time point evaluations (15 minutes and 12 hours) as compared to those receiving control lenses in the study.
Secondary endpoints in the trials evaluated the reduction in eye redness (ciliary, conjunctival and episcleral vessel beds) while wearing the antihistamine-releasing lens. The antihistamine-releasing lenses did not demonstrate a clinically significant reduction in eye redness.
In the studies, both the antihistamine-releasing contact lenses and control lenses demonstrated a low rate of ocular adverse events (4.9% overall) with the majority being mild and not considered study related. The most commonly reported adverse events associated with the antihistamine-releasing lenses were stinging upon insertion (1.7%) and temporary pupil enlargement (2.1%). The stinging upon insertion was generally classified as mild and there were no discontinuations from study treatment based on these or any other ocular adverse events.