The Phase 3 studies, conducted in 2007, involved a total of 244 patients, divided into three cohorts. In the first patients wore a plain lens made of etafilcon a in one eye and the same lens treated with 0.019mg of the drug ketotifen in the other eye. In the second group, patients wore treated lenses in both eyes; the third group was the control, consisting of patients wearing placebo lenses in both eyes. There were about 40 subjects in each group.
Patients wearing the treated lenses underwent allergen challenge at 12 hours and were tested for ocular itching and redness. In a second office visit subjects underwent an allergy challenge after 15 minutes. In both studies the primary outcome was ocular itching, with secondary endpoints of ciliary, conjunctival and episcleral redness.
Mean itch scores for the treated eyes were statistically significant 15 minutes after lens insertion and after 12 hours, but none of the redness score changes were of clinical significance. The adverse event rate was 4.9% in 488 subject eyes, with all but two deemed mild and not related to the study. The other two severe AEs involved a pregnant woman who opted out of one of the trials and another who reported increased tear flow in both eyes. Visual acuity was similar in both the control and treated cohorts.
“There is no evidence from either study that the incorporation of the drug into the lens solution has any structural, optical, or refractive effect on the lenses. The 12-hour time point equals the longest duration of clinical efficacy demonstrated by ketotifen in a CAC-based study; this suggests that the CL-based delivery does not interfere with the established prolonged duration of ketotifen action,” the study’s authors wrote in the March 19 issue of the journal Cornea. “At the same time, the lenses provided effective refractive error correction. Overall, the combination lens was well tolerated. Collectively, these results support the use of lenses with ketotifen for the prevention of ocular itching associated with AC in patients who use CLs for vision correction.”
“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,” lead author Brian Pall, director of clinical science at J&J Vision, said in prepared remarks. “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.”
“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,” added J&J Vision global R&D head Dr. Xiao-Yu Song. “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.”