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）第二阶段项目旨在开发一种生物启发的隐形透镜，它可以紧密模仿天然泪膜的结构，并预防隐形眼镜引起的干眼症（CLIDE）。 CLIDE是50%的隐形透镜配戴者面临的严重问题。尽管材料和透镜设计不断进步，但估计每年仍有10%的患者因CLIDE干燥和不适症状而停止使用。所提出的透镜的结构通过使用与眼部环境接触的高含水量聚乙二醇（PEG）水凝胶来最小化泪膜破坏。独特的多层设计将使接触透镜设计的新范例成为可能，迄今为止接触透镜设计依赖于改性共聚物共混物，而不是利用本体材料的离散层。 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中的安全性。该项目的结果将使人类受试者的有效性研究成为可能。如果成功，该项目更广泛的影响/商业潜力将是一种缓解干燥和不适的接触透镜。 全球隐形透镜市场每年为68亿美元，患者由于不适而停止佩戴透镜估计损失6.8亿美元的收入。除了显著的商业潜力和改善患者舒适度的能力之外，这种接触透镜的开发将在眼科和医疗器械领域产生更广泛的影响。通过更好地了解泪膜-晶状体相互作用，可以采用更可靠、客观和可量化的指标来预测成功率并对患者进行细分。新的透镜架构还可以使得能够更好地理解在比较接触镜片的舒适度中使用的各种度量。 此外，该器械将确认该独特材料/设计在其他潜在医疗器械应用中的使用。 本项目正在开发的薄膜水凝胶沉积新工艺和技术在临床科学和基础研究中具有广泛的应用。

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.