INDUSTRIAL SCIENCE & TECHNOLOGY NETWORK, INC. — Department of Health and Human Services SBIR Phase I: M

Description

PROJECT SUMMARY Over the last two decades the commercialization of silicone hydrogel andquot SiHyandquot composite technologies has led to new soft CLs that are more breathable comfortable and affordable including in daily disposable versions which have considerably broadened the customer base especially among younger generations Despite these improvements the major persistent problem facing contact lenses is their poor compatibility with ocular environment particularly the tear film While the softness of the new composite materials made lenses more comfortable by conforming better to the cornea the resultant tight fitting considerably lowers the tear exchange rate in the post lens tear film In addition the precision of lens design and fabrication limited by the difficulties of the thermal expansion of a dual domain silicon and hydrogel substrate are adequate only for adjusting an imageandapos s focus not its visual acuity caused by other higher order optical aberrations We propose to solve these issues by creating a novel contact lens material that will lead to a new best in class soft lens with significant improvements in vision correction clarity and comfort and wide applicability to numerous patient populations This project will engineer the new generation of lens innovations based on several recent advances in material and fabrication nanotechnologies The combined application of submicron morphology control molecular self assembly and high precision molding as well as D printing will make future CL devices more precise biocompatible and versatile We identified three major areas of improvement in CLs that will benefit from our implementation of such new emerging technologies a Pre synthesis of new silicone block copolymers for higher precision control of domain morphology during lens fabrication b Application of high precision fabrication and high definition andquot HDandquot design for correcting the spherical aberration of CLs and c Engineering a novel design of lens material and surface coating for enhancing PLTF turnover to improve ocular health The new product would widely replace current CLs for at least the million patients in the US market and likely expand this market significantly with new and valuable functions such as control of myopia progression for adolescents and night vision enhancements for the elderly by high precision control and high definition design as well as unprecedented comfort and biocompatibility by new surface coatingandapos s enhancement of PLTF turnover Further the new level of comfort and extended wear time would solve one key challenge associated with current state of the art in ocular drug delivery and monitoring devices promoting our technology to a future platform for growing these applications to treat other large populations such as the million glaucoma patients worldwide PROJECT NARRATIVE Soft contact lenses are an $ billion commercial market and worn by million people in the U S increase from In addition to limitations in design precision that affect visual clarity of the lens a major related health problem is lens biocompatibility which can lead to numerous patient complications and discomfort including notably acanthamoeba keratitis $ million healthcare costs per year in the U S We propose to solve this problem by developing an advanced silicone hydrogel SiHy contact lens with novel tear exchange mechanism and better visual precision fully compatible with the ocular environment This new generation of materials will allow for extended wear times beyond the current accepted modalities week monthly and create new opportunities for corrective functions e g night vision enhancement myopia progression control as well as a future platform for commercially viable ocular health monitoring and drug delivery lenses