Glaucoma is the leading cause of irreversible blindness worldwide and the leading cause of blindness in African Americans. Research shows that the prevalence of glaucoma is expected to increase by 50% in the next 15 years. Although medical treatment with topical eye drops can be effective at reducing the risk of blindness from the disease, many patients with glaucoma do not take their eye drops as prescribed. One reason for glaucoma medication non-adherence is the inability of patients to accurately and safely administer a drop into their eye with traditional eye drop bottles. [Proper adherence to prescribed glaucoma drops requires obtaining medication, successfully instilling a drop into the eye and doing so at the appropriate time interval without missing doses.] Recent investigations indicate that up to 25% of experienced users cannot administer a drop into the eye under clinical observation and 70% contaminate the tip of the bottle in the process. Many patients with glaucoma have comorbid conditions including arthritis and tremor. These conditions make it difficult to apply the correct amount of force to distill a single drop. In addition, current droppers require the patient to tilt their head in the reclined position which can be difficult, awkward and uncomfortable. Finally, the patient may have difficulty determining the distance between the eye dropper tip and their eye with traditional bottles, resulting in opportunities for contamination. The goal of this Phase I project is to solve these problems and enhance medication adherence by glaucoma patients. Together, Gilero Biomedical and the Duke Eye Center propose to develop a novel eye drop bottle with the following innovative components: upright delivery, metered dose, and distance control, minimizing contamination. Our first specific aim is to improve the design of the novel eye drop bottle, with clinical input from the Duke Eye Center. To accomplish the first specific aim, Gilero will design and build prototypes [compatible with off-the-shelf eye bottles] and test for functionality. Our second specific aim is to perform an observational study in glaucoma patients to compare the performance of the novel eye dropper to traditional eye bottles [and the Cress Dropper]. To accomplish the second specific aim, Gilero will manufacture prototypes for the study and the Duke Eye Center will collect qualitative feedback from patients. Phase II will focus on implementing design improvements based on input collected during the Phase I study. A larger human study will be conducted during Phase II and manufacturing will transition from prototype to production scale. Gilero, an established product development company, has successfully designed and commercialized medical devices. The Duke Eye Center has previously been the recipient of several grants from the National Eye Institute and Research to Prevent Blindness. Thus, the collaboration between Gilero and the Duke Eye Center offers a strong foundation of product development, clinical input, and commercialization experience. The successful development of this product will lead to a substantial improvement in the care of glaucoma patients, with possible expansion into other treatment areas.

Public Health Relevance

Despite effective medical treatment, some patients with glaucoma continue to experience vision loss and blindness from the disease. For some of these patients, loss of vision may be directly attributable to ineffective instillation of eye drops, whih has shown to be poor in at least 30% of patients with the disease. A novel eye drop bottle that allows glaucoma patients to more effectively self-manage their disease could reduce preventable vision loss in this vulnerable population.

National Institute of Health (NIH)
National Eye Institute (NEI)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-ETTN-G (12))
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Wujek, Jerome R
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Gilero, LLC
Research Triangle Park
United States
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