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Menicon Z 30-Day Continuous Wear Lenses: A Clinical Comparison to Acuvue 7-Day Extended Wear Lenses

Gleason, William O.D.; Albright, Roger A. M.B.A.

Eye & Contact Lens: Science & Clinical Practice: January 2003 - Volume 29 - Issue 1 - p S149-S152
CONTENTS: SESSION VI: HOW POPULAR WILL CONTINUOUS WEAR BECOME?
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Purpose. 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.

Conclusion. 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.

Address correspondence to: William Gleason, Foresight Regulatory Strategies, Inc., 269A Ballardvale Street, Wilmington, MA 01887. Phone: (978) 658-6888; fax: (978) 658-6803; e-mail: bgleason@4-sight.net.

© 2003 Lippincott Williams & Wilkins, Inc.