Novel Eye Dropper to Improve Adherence of Glaucoma Medicine Administration

新型滴眼器可提高青光眼药物给药的依从性

• 批准号: 8642376
• 负责人: Theodore Jay Mosler
• 金额: $ 15.63万
• 依托单位: GILERO, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8642376
• 关键词: Adherence; Affect; African American; American; Area; Arthritis; Blindness; Brassicaceae; Caring; Cheek structure; Clinical; Collaborations; Computer-Aided Design; Data; Devices; Disease; Dose; Drops; Effectiveness; Engineering; Ensure; Equipment; Eye; Eyedrops; Face; Feasibility Studies; Feedback; Foundations; Glaucoma; Goals; Grant; Head; Health; Investigation; Joints; Lead; Liquid substance; Marketing; Measurement; Measures; Medical; Medical Device; Medicine; Modeling; National Eye Institute; Observational Study; Outcome; Patient Noncompliance; Patients; Performance; Pharmaceutical Preparations; Phase; Population; Positioning Attribute; Prevalence; Problem Solving; Process; Production; Regimen; Research; Rest; Risk; Self-Administered; Shapes; Skin; Test Result; Testing; Time; Touch sensation; Tremor; Variant; Vendor; Visual; Visual impairment; Vulnerable Populations; base; commercialization; design; ergonomics; experience; eye center; human study; improved; innovation; medication compliance; meetings; meter; novel; ocular surface; performance tests; phase 1 study; prevent; product development; prototype; public health relevance; scale up; time interval

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.

青光眼是世界范围内不可逆失明的主要原因，也是世界范围内失明的主要原因。 非裔美国人研究表明，青光眼的患病率预计将增加50%， 未来15年。虽然局部滴眼液的药物治疗可以有效地降低 青光眼是一种致盲性疾病，许多青光眼患者不按处方服用眼药水。一 青光眼药物治疗不依从的原因是患者不能准确和安全地给药， 用传统的眼药水瓶滴入眼睛。[正确遵守规定的青光眼滴需要 获得药物，成功地滴入眼睛，并在适当的时间间隔这样做 没有遗漏剂量）。最近的调查表明，多达25%的有经验的用户无法管理 在临床观察中，一滴进入眼睛，70%在过程中污染瓶尖。许多 青光眼患者具有包括关节炎和震颤的共病状况。这些条件使得 很难用正确的力来蒸馏出一滴此外，电流下降器需要 患者倾斜他们的头在斜倚位置，这可能是困难的，笨拙的和不舒服的。最后 患者可能难以确定滴眼器尖端与其眼睛之间的距离 瓶子，导致污染的机会。这个一期工程的目标就是解决这些问题 并增强青光眼患者的药物依从性。Gilero Biomedical和杜克眼科 中心建议开发一种新型滴眼液瓶，具有以下创新组件： 输送、定量和距离控制，最大限度地减少污染。我们的首要具体目标是 根据杜克眼科中心的临床意见，改进新型滴眼液瓶的设计。完成 作为第一个具体目标，Gilero将设计和制造原型[与现成的眼瓶兼容]并进行测试 功能性。我们的第二个具体目标是在青光眼患者中进行观察性研究， 新型滴眼器相对于传统滴眼瓶[和水芹滴眼器]的性能。完成 第二个具体目标是，Gilero将为这项研究制造原型，杜克眼科中心将收集 患者的质量反馈。第二阶段将侧重于根据投入实施设计改进 在I期研究期间收集。将在II期和生产期间进行更大规模的人体研究 将从原型过渡到生产规模。Gilero是一家成熟的产品开发公司， 成功设计和商业化的医疗设备。杜克眼科中心以前是 国家眼科研究所和预防失明研究所的几笔赠款的获得者。因此 Gilero与杜克眼科中心的合作为产品开发奠定了坚实的基础， 临床投入和商业化经验。这一产品的成功开发将导致 青光眼患者的护理得到实质性改善，并可能扩展到其他治疗领域。