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).
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.
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.
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.
From Foresight Regulatory Strategies, Inc., Wilmington, MA.
Accepted September 27, 2002.
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