Prevention of Children's Tympanostomy Tube Otorrhea

项目摘要 中耳炎(中耳间隙感染)是儿童最常见的疾病之一。鼓膜切开术 鼓膜切开置管是美国儿童最常见的手术 各州。耳漏是插管后最常见的并发症，可发生在高达17%的耳朵 接受TT感染，通常与活动性感染有关。目前的治疗方法包括给药 抗生素或抗生素/类固醇每日两次，连续14天。虽然这降低了感染的发生率， 儿童存在患者依从性和暂时性传导性听力损失的问题。增强版 治疗方案将改善治疗效果，增加患者的依从性。 这项第二阶段的SBIR提案涉及对以下治疗方法的制造和安全性的验证 儿童鼓室造瘘管相关性中耳炎。这项提案的具体目标是 开发可局部输送类固醇和抗生素的缓释水凝胶的路线图 已经14天了。这项提议的目的有三个：第一，制造扩展的 将按照FDA的GMP生产指南释放水凝胶，用于第一阶段临床试验。第二, 将测试缓释水凝胶各组分的无菌性和稳定性。最后，一口井- 将进行评估缓释水凝胶及其成分的安全性的对照研究 在良好的实验室操作条件下。该项目的完成将完成所有的临床前研究。 启动I期临床研究所需的。 O-Ray的调查团队是唯一有资格执行本文建议的工作的团队，并已 在耳科、药物开发和药物输送方面的专业知识为该产品的成功开发奠定了基础。O-射线 科学家们已经成功地开发出目前正在临床上使用的治疗配方。这 包括能够维持玻璃体内抗炎的眼内缓释类固醇植入物 一次植入后长达3年的药物水平。该项目的下一阶段将涉及 与企业合作伙伴合作，获得我们开发的产品的许可并启动临床 审判。

Project Summary Otitis media (infection of the middle ear space) is one of the most common diseases of childhood. Myringotomy with tympanostomy tube (TT) insertion is the most common operation performed on children in the United States. Otorrhea is the most common complication following tube insertion and can occur in up to 17% of ears receiving TT and is often associated with active infection. Current treatments involve the administration of antibiotic or antibiotic/steroid drops twice a day for 14 days. Though this decreases the incidence of infection, there are issues with patient compliance and temporary conductive hearing loss in the children. An enhanced treatment option would improve treatment efficacy and increase patient compliance. This Phase II SBIR proposal involves the validation of manufacturing and safety of therapeutic treatments for otitis media associated with tympanostomy tubes in children. The specific aims of this proposal present a roadmap towards the development of an extended release hydrogel to deliver steroids and antibiotics locally for 14 days. The aims of this proposal are threefold: First, manufacturing of the components of the extended release hydrogel using FDA guidelines for GMP manufacturing for Phase 1 clinical trials will be done. Second, the sterility and stability of the components of the extended release hydrogel will be tested. Lastly, a well- controlled study assessing the safety of the extended release hydrogel and its components will be performed under Good Laboratory Practice conditions. The completion of this project will finish all preclinical studies required for the initiation of Phase I clinical studies. The team of investigators at O-Ray is uniquely qualified to perform the work proposed herein, and has expertise in otology, drug development and drug delivery for the successful development this product. O-Ray scientists have successfully developed therapeutic formulations that are currently being used in the clinic. This includes an intraocular sustained release steroid implant capable of maintaining anti-inflammatory intravitreal drug levels for periods of up to 3 years from a single implantation. The next stage of this project will involve the collaboration with a corporate partner for the licensing of our developed product and the initiation of clinical trials.