A 1-year prospective clinical trial of Menicon Z (tisilfocon A) rigid gas-permeable contact lenses worn on a 30-day continuous wear schedule

Purpose. To establish the safety and efficacy of clinical performance of a novel hyper-O₂-transmitting rigid gas-permeable (RGP) lens (tisilfocon A) worn continuously for 30 days (29 nights) equivalent to a conventional control hydrogel lens (etafilcon A) worn for 7 days (6 nights). Methods. The study was a prospective, open-label, 24-center, concurrent cohort-controlled clinical trial. Outcome Measures. Outcome measures included rates of adverse events, slitlamp findings, length of wear achieved, lens-corrected visual acuity, corneal refractive changes, dryness, and lens deposits. Results. The RGP lens wear test was equivalent or superior to the hydrogel control performance in all categories. Two-thirds (66.5%) of patients wearing the RGP lens achieved continuous wear periods greater than 22 nights; and 60.4% achieved more than 28 nights of continuous use. There was a statistically significant lower rate of adverse events, considered definitely related to lens wear, for the RGP test lens versus the hydrogel control (none vs. 2.2%; P = 0.007, Fisher's exact two-sided test). Conclusions. Continuous wear of the tisilfocon A (Menicon Z, Menicon Co., Ltd., Nagoya, Japan) RGP lens for up to 30 nights is a safe and equivalent alternative to 7-day (6-night) hydrogel wear.