Prevention of Children's Tympanostomy Tube Otorrhea

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CRP SBIR提案涉及为启动临床试验准备材料， 释放水凝胶以局部递送类固醇和抗生素，用于治疗TT相关的耳炎。的 该提案的目标有三个方面：第一，设计和规划1期临床试验，包括 完成研究者手册。第二，制定监管策略，包括 编写IND提交文件，与FDA举行IND前会议，并提交 印第安纳最后，与制造有关的技术援助，特别是确定合同制造商 用于扩大2/3期临床试验材料的GMP生产规模。该项目的完成将 帮助公司获得后续资金，以完成I期临床研究。 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 获得天使/风险投资团体的投资，以启动临床试验。

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 CRP SBIR proposal involves the preparation of materials for the initiation of clinical trials for an extended release hydrogel to deliver steroids and antibiotics locally for the treatment of TT associated otorrhea. The aims of this proposal are threefold: First, designing and planning for a Phase 1 clinical trial, including completion of the Investigator's Brochure. Second, the development of a regulatory strategy, including compiling documents for submission of an IND, holding a pre-IND meeting with the FDA, and submitting the IND. Lastly, technical assistance associated with manufacturing, specifically identifying contract manufacturers for scale-up of GMP production of material for Phase 2/3 clinical trials. The completion of this project will situate the company for obtaining follow-on funding for the completion 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 obtaining investment Angel/Venture groups for the initiation of clinical trials.