Johnson & Johnson Vision has reported positive data from two Phase III clinical trials of its antihistamine-releasing contact lens, which is designed to correct vision and reduce eye itch due to allergies.
Findings revealed that patients who used the investigational lens demonstrated reduced mean itching scores when their eyes were exposed to allergens, compared with those wearing a non-medicated lens.
The company noted that a clinically and statistically significant decrease in ocular itching was observed 15 minutes after insertion of its lens. The improvement was retained for the 12-hour study period.
Results from the trials have been published in the Cornea Journal.
Johnson & Johnson Vision Care clinical science director Brian Pall said: “Contact lens wearers who historically suffer from itchy, allergy eyes had meaningful reductions in itching across two randomised, well-controlled studies.
“This marks the first time that contact lens technology has shown potential in a large-scale study to address itch stemming from ocular allergies.”
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Exposure to allergens leads to ocular allergy in more than 20% of people living in the US, according to the Cornea publication. This condition is prevalent globally.
Johnson and Johnson developed disposable drug-releasing contact lenses to address the itch associated with ocular allergies.
Its antihistamine-releasing lens contains the ketotifen drug, which is known to inhibit some substances involved in allergic reactions and inflammation.
The two multi-centre, double-masked, randomised, placebo-controlled trials evaluated the lens in a total of 244 patients. During the studies, efficacy was measured using the conjunctival allergen challenge model (Ora-CAC).
The primary study endpoint was itching scores and secondary endpoints included a reduction in eye redness. Though the antihistamine-releasing lens decreased eye redness, the improvement was not clinically significant.
Ocular adverse events during the trials were low, with most common adverse events being stinging upon insertion and temporary pupil enlargement.
The company plans to submit regulatory applications for this antihistamine-releasing contact lens.