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THIRTY-DAY EXTENDED-WEAR CONTACT LENS TRIALS SHOULD INCLUDE MORE THAN 400 TREATED EYES, FDA PANEL RECOMMENDS; AGENCY PREPARES PANEL FOR EVENTUAL PDP

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers seeking FDA approval of extended-wear contact lenses intended to be worn up to 30 days at a time likely will need to conduct studies on lenses made of new materials in more than 400 test eyes and an equal number of control eyes, FDA's Ophthalmic Devices Panel agreed at a Feb. 12 meeting in Rockville, Maryland. FDA's existing guidance for studies of seven-day extended-wear lenses recommends that sponsors include 400 test eyes and 200 control eyes.
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