Menicon Z 30-day continuous wear lenses: a clinical comparison to Acuvue 7-day extended wear lenses.
OBJECTIVE
To establish equivalent safety and efficacy of the clinical performance of a novel hyper-O2 transmissible rigid gas-permeable (RGP) lens (Menicon Z, tisilfocon A) when worn continuously for 30 days (29 nights) when compared with a conventional control hydrogel lens (Acuvue; etafilcon A) worn for 7 days (6 nights).


METHODS
This study was a prospective, open-label, 24-center, concurrent, cohort-controlled clinical trial. This abbreviated report will focus on the length of wear achieved, slitlamp findings, and adverse event rates.


RESULTS
Two-thirds (66.5%) of patients wearing the RGP lens achieved greater than or equal to 22 nights of continuous wear; slitlamp observations revealed two categories of findings: those associated with lens modality and those with lens wearing time. Adverse events were mostly associated with foreign body abrasions for RGP lenses, whereas the hydrogel lens showed a higher number of bacterial infections.


CONCLUSIONS
The results of this study revealed some interesting differences in the classification and severity of findings. The results demonstrate that the continuous wear of Menicon Z (tisilfocon A) RGP lenses for up to 30 nights is a safe and equivalent alternative to 7-day (6 nights) hydrogel wear lenses.
Gleason
William
W
Foresight Regulatory Strategies, Inc., Wilmington, MA 01887, USA. bgleason@4-sight.net
Albright
Roger A
RA
D000328:Adult; D001672:Biocompatible Materials / Q000009:adverse effects; D003262:Contact Lenses, Extended-Wear / Q000009:adverse effects; D003316:Corneal Diseases / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008768:Methylmethacrylates / Q000009:adverse effects; D017060:Patient Satisfaction; D011446:Prospective Studies; D012449:Safety; D012828:Silicones / Q000009:adverse effects; D014792:Visual Acuity
D001672:Biocompatible Materials; D008768:Methylmethacrylates; D012828:Silicones; C041037:menicon O2