SBIR-STTR Award

This Small Business Innovation Research (SBIR) Phase I project proposes to develop a contact lens for the treatment of dry eye disease, which affects more than 6 million people in the United States. The contact lens is designed to be placed on the surface of the eye to relieve symptoms of pain and irritation associated with ocular dryness. There is no device currently on the market with this design and function, and the objectives of this research are to refine and characterize the lens as well as to test the safety and efficacy of the device in animal studies. Ultimately, this research will enable efficacy studies in humans. The broader impact/commercial potential of this proposed project is the potential to improve treatment of dry eye disease. The cost of treating dry eye disease in the United States is $2 billion dollars annually, despite the relative ineffectiveness of current therapies. Not only will this device improve the quality of life of millions of people, but it will also validate the use of our unique material/design for medical devices in general, which may have a much broader application. This device represents one of very few non-pharmaceutical therapies for dry eye disease, and, therefore, has the potential to broaden the thinking of the scientific community with regard to methods of dry eye treatment

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.