Results from two phase 3 studies evaluating an investigational antihistamine-releasing contact lens (etafilcon A with ketotifen 0.019mg) showed that the treatment may benefit patients who need vision correction and also suffer from ocular allergies.
The daily disposable lenses contain ketotifen, an agent that has both antihistamine and mast-cell stabilizing properties. In the placebo-controlled studies, 244 patients were randomized to receive either the antihistamine-releasing lens or placebo lens. Patients would then receive an allergen challenge at 15 minutes (to test onset) and 12 hours (to test duration) after which they would report the severity of their itching symptoms using a 0 (no itch) to 4 (incapacitating itch) scale (primary endpoint).
Results showed that across both trials, patients wearing the antihistamine-releasing lenses had a clinically and statistically significant reduction in mean itching scores compared with those who wore control lenses (mean score difference ≥1) at both time points. However, a clinically significant reduction in eye redness (secondary endpoint) was not observed in the studies.
With regard to safety, the most commonly reported adverse events associated with the antihistamine-releasing lenses were stinging upon insertion and temporary pupil enlargement; none of the patients in the trials discontinued treatment because of these ocular adverse events.
“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,” said Xiao-Yu Song, PhD, MD, Global Head of Research and Development, Johnson & Johnson Vision Care, Inc. “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.”
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