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

这项小型企业创新研究（SBIR）二期项目旨在开发一种仿生隐形眼镜，这种隐形眼镜与天然泪膜的结构非常相似，可以预防隐形眼镜引起的干眼病（CLIDE）。近视是50%隐形眼镜佩戴者面临的严重问题。尽管在材料和镜片设计方面取得了进步，但估计每年仍有10%的患者由于干燥和不适的CLIDE症状而停止使用。该隐形眼镜的结构通过使用高含水量的聚乙二醇（PEG）水凝胶与眼部环境相结合，最大限度地减少了泪膜的破坏。这种独特的多层设计将使隐形眼镜设计成为一种新的范例，到目前为止，这种设计依赖于修改共聚物混合物，而不是使用离散层的大块材料。该研究项目的目标是开发和优化可扩展的制造工艺，以生产镜片并验证其在动物身上的安全性。这个项目的结果将使人类受试者的功效研究成为可能。如果这个项目成功，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的规模为68亿美元，其中，由于患者感到不适而停止佩戴隐形眼镜造成的收入损失估计为6.8亿美元。除了具有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。通过更好地了解泪液膜-晶状体的相互作用，更可靠、客观和可量化的指标将有可能预测成功并对患者进行分类。新的镜片结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材料/设计在其他潜在医疗设备应用中的使用。本课题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具有广泛的应用前景。

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.