Glaucoma is the leading cause of irreversible blindness worldwide and the leading cause of blindness inAfrican Americans. Research shows that the prevalence of glaucoma is expected to increase by 50% in thenext 15 years. Although medical treatment with topical eye drops can be effective at reducing the risk ofblindness from the disease, many patients with glaucoma do not take their eye drops as prescribed. Onereason for glaucoma medication non-adherence is the inability of patients to accurately and safely administer adrop into their eye with traditional eye drop bottles. [Proper adherence to prescribed glaucoma drops requiresobtaining medication, successfully instilling a drop into the eye and doing so at the appropriate time intervalwithout missing doses.] Recent investigations indicate that up to 25% of experienced users cannot administera drop into the eye under clinical observation and 70% contaminate the tip of the bottle in the process. Manypatients with glaucoma have comorbid conditions including arthritis and tremor. These conditions make itdifficult to apply the correct amount of force to distill a single drop. In addition, current droppers require thepatient to tilt their head in the reclined position which can be difficult, awkward and uncomfortable. Finally, thepatient may have difficulty determining the distance between the eye dropper tip and their eye with traditionalbottles, resulting in opportunities for contamination. The goal of this Phase I project is to solve these problemsand enhance medication adherence by glaucoma patients. Together, Gilero Biomedical and the Duke EyeCenter propose to develop a novel eye drop bottle with the following innovative components: uprightdelivery, metered dose, and distance control, minimizing contamination. Our first specific aim is toimprove the design of the novel eye drop bottle, with clinical input from the Duke Eye Center. To accomplishthe first specific aim, Gilero will design and build prototypes [compatible with off-the-shelf eye bottles] and testfor functionality. Our second specific aim is to perform an observational study in glaucoma patients to comparethe performance of the novel eye dropper to traditional eye bottles [and the Cress Dropper]. To accomplish thesecond specific aim, Gilero will manufacture prototypes for the study and the Duke Eye Center will collectqualitative feedback from patients. Phase II will focus on implementing design improvements based on inputcollected during the Phase I study. A larger human study will be conducted during Phase II and manufacturingwill transition from prototype to production scale. Gilero, an established product development company, hassuccessfully designed and commercialized medical devices. The Duke Eye Center has previously been therecipient of several grants from the National Eye Institute and Research to Prevent Blindness. Thus, thecollaboration 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 asubstantial improvement in the care of glaucoma patients, with possible expansion into other treatment areas.
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