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


METHODS
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.
Gleason
William
W
Menicon, Ltd. Nagoya, Japan.
Tanaka
Hidenari
H
Albright
Roger A
RA
Cavanagh
H Dwight
HD
D000328:Adult; D001672:Biocompatible Materials; D003262:Contact Lenses, Extended-Wear / Q000009:adverse effects / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D011446:Prospective Studies; D012029:Refraction, Ocular; D012449:Safety; D016896:Treatment Outcome; D014792:Visual Acuity
D001672:Biocompatible Materials