The Ministry of Food and Drug Safety (headed by Director Oh Yoo-gyeong) announced on November 17 that it has established and published guidelines for writing clinical trial protocols for “corneal refractive correction contact lenses,” which are mainly used for correcting myopia in children and adolescents.
“Corneal refractive correction contact lenses” are hard contact lenses that, when worn during sleep at night, temporarily change the shape of the cornea by pressing the central part of the cornea, thereby temporarily correcting myopia during the day.
The new guidelines have been prepared in response to the increasing use of digital devices and the rise of online classes, which have led to a growing number of people with myopia, thereby boosting the development of corneal refractive correction contact lenses in Korea. The Ministry explained that it provides concrete examples, including clinical trial planning and evaluation methods, to aid in the preparation of materials.
The main contents of the guidelines include items and methods for preparing clinical trial protocols, internationally harmonized clinical design methods with examples, and evaluation methods and criteria during clinical trials.
The Ministry of Food and Drug Safety expects that by publishing these guidelines, they will support the development of medical devices in fields closely related to public life and with high growth potential, thus contributing to the promotion of public health and strengthening the international competitiveness of domestic companies.
The regulatory body also announced its plans to ensure the safety and efficacy of products applying innovative technology due to technological advancements continually. They aim to provide support so that products can be rapidly developed and launched by leveraging regulatory science expertise.
The detailed contents of the guidelines can be accessed on the Ministry of Food and Drug Safety’s website under ‘Laws/Resources → Legal Information → Public Official’s Guide/Customer Guide’.