Prevention of Children's Tympanostomy Tube Otorrhea

儿童鼓膜置管性耳漏的预防

• 批准号: 9202195
• 负责人: ERIK PIERSTORFF
• 金额: $ 63.45万
• 依托单位: O-RAY PHARMA, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-16 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9202195
• 关键词: Affect; Animal Model; Anti-Inflammatory Agents; Anti-inflammatory; Antibiotics; Cavia; Child; Childhood; Ciprofloxacin; Clinic; Clinical Research; Clinical Trials; Collaborations; Complication; Conductive hearing loss; Controlled Study; Development; Dexamethasone; Disease; Dose; Drops; Drug Delivery Systems; Ear; Effectiveness; Environment; FDA approved; Formulation; Funding; Future; Goals; Guidelines; Hearing; Histology; Hydrogels; Implant; Incidence; Industry; Infection; Injectable; Injection of therapeutic agent; Investigational Drugs; Labyrinth; Licensing; Marketing; Medical Device; Methods; Modeling; Monitor; Otitis Media; Otology; Otorrhea; Penetration; Performance; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Polymers; Preparation; Prevention; Procedures; Qualifying; Research Contracts; Research Personnel; Risk; Safety; Scientist; Small Business Innovation Research Grant; Staging; Sterility; Sterilization; Steroids; Suspension substance; Suspensions; Testing; Therapeutic; Time; Toxic effect; Treatment Efficacy; Tube; Tympanostomy; Tympanostomy Tube Insertions; United States; Validation; Work; compliance behavior; drug development; experience; good laboratory practice; hearing impairment; implantation; improved; middle ear; operation; particle; preclinical safety; preclinical study; product development; safety study; stability testing; success

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.

项目摘要 中耳炎（中耳腔感染）是儿童最常见的疾病之一。鼓膜切开 鼓膜造口管（TT）插入是美国儿童最常见的手术 states.耳畸形是插管后最常见的并发症，可发生在高达17%的耳中 接受TT，通常与活动性感染有关。目前的治疗方法包括给予 抗生素或抗生素/类固醇滴剂，每天两次，持续14天。虽然这降低了感染的发生率， 存在患者依从性和儿童暂时传导性听力损失的问题。增强的 治疗选择将提高治疗效果并增加患者依从性。 该II期SBIR提案涉及以下治疗性治疗的生产和安全性验证： 儿童鼓膜造孔管相关性中耳炎该提案的具体目标是， 开发缓释水凝胶以局部递送类固醇和抗生素的路线图 14天。该提案的目的有三个方面：第一，制造扩展的 将使用FDA关于GMP生产的指南进行1期临床试验的水凝胶释放。第二、 测试缓释水凝胶组分的无菌性和稳定性。最后，一个很好的- 将进行对照研究，评估缓释水凝胶及其组分的安全性 在良好实验室规范条件下。该项目的完成将完成所有临床前研究 启动I期临床研究所需。 O-Ray的研究人员团队是唯一有资格执行本文提出的工作的团队， 在耳科，药物开发和药物输送方面的专业知识，成功开发了该产品。O-Ray 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 包括眼内持续释放类固醇植入物，其能够维持抗炎性玻璃体内 单次植入后长达3年的药物水平。该项目的下一阶段将涉及 与公司合作伙伴合作，为我们开发的产品提供许可，并启动临床试验。 审判