SBIR Phase II: Bio-inspired Multilayer Contact Lens to Treat Contact Lens-Induced Dry Eye Disease

这个小型企业创新研究(SBIR)第二阶段项目旨在开发一种仿生隐形眼镜，该隐形眼镜接近自然泪膜的结构，并防止隐形眼镜引发的干眼症(CLIDE)。近视是50%的隐形眼镜佩戴者面临的一个严重问题。尽管材料和镜片设计有所进步，但估计每年仍有10%的患者因干涩和不适症状而停止使用。建议的镜片结构通过使用与眼睛环境相连接的高水分聚乙二醇水凝胶来最大限度地减少泪膜破坏。独特的多层设计将在隐形眼镜设计中实现一种新的范例，到目前为止，这种设计一直依赖于对共聚物混合物的改性，而不是使用离散的块状材料层。这项研究项目的目标是开发和优化可扩展的制造工艺，以生产这种镜片并在动物身上验证其安全性。该项目的结果将使人类受试者能够进行疗效研究。如果该项目成功，其更广泛的影响/商业潜力将是一种缓解干燥和不适的隐形眼镜。全球隐形眼镜市场每年价值68亿美元，据估计，患者因不适而停止佩戴隐形眼镜造成的收入损失约为6.8亿美元。除了巨大的商业潜力和改善患者舒适度的能力外，这种隐形眼镜的开发还将在眼科和医疗器械领域产生更广泛的影响。通过更好地了解泪膜-晶状体的相互作用，更可靠、客观和可量化的指标来预测成功率和细分患者将成为可能。新的镜片架构还可以更好地理解用于比较隐形眼镜舒适度的各种指标。此外，该设备将验证这种独特的材料/设计在其他潜在的医疗设备应用中的使用。本项目正在开发的薄膜水凝胶沉积新工艺和新技术在临床科学和基础研究中都有广泛的应用。

This Small Business Innovation Research (SBIR) Phase II project aims to develop a bio-inspired contact lens that closely mimics the structure of natural tear film, and prevents contact lens-induced dry eye disease (CLIDE). CLIDE is a serious problem faced by 50% of contact lens wearers. In spite of advances in materials and lens design, an estimated 10% of patients discontinue use each year due to CLIDE symptoms of dryness and discomfort. The architecture of the proposed lens minimizes tear film disruption through the use of a high water content polyethylene glycol (PEG) hydrogel that interfaces with the ocular environment. The unique multi-layered design will enable a new paradigm in contact lens design, which so far has relied on modifying copolymer blends rather than making use of discrete layers of bulk materials. The objectives of this research project are to develop and optimize scalable manufacturing processes to produce the lenses and validate their safety in animals. The results of this project will enable efficacy studies in human subjects.The broader impact/commercial potential of this project, if successful, will be a contact lens that alleviates dryness and discomfort. The global contact lens market is $6.8 billion dollars annually, with an estimated $680 million dollars in revenue lost from patients discontinuing lens wear due to discomfort. In addition to the significant commercial potential, and ability to improve patient comfort, development of this contact lens will have broader impacts in the ophthalmology and medical device fields. Through better understanding of the tear film-lens interactions, more reliable, objective, and quantifiable metrics to predict success and segment patients will be possible. The new lens architecture also may enable a better understanding of the various metrics used in comparing the comfort of contact lenses. In addition, this device will validate the use of this unique material/design for other potential medical device applications. The novel processes and technology under development in this project for thin film hydrogel deposition has broad application both in clinical science and fundamental research.