Prevention of Children's Tympanostomy Tube Otorrhea

儿童鼓膜置管性耳漏的预防

基本信息

批准号：
10011523
负责人：
Matthew Ku
金额：
$ 28.45万
依托单位：
O-RAY PHARMA, INC.
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-16 至 2022-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10011523
关键词：
Affect Anti-Inflammatory Agents Antibiotics Chemistry Child Childhood Ciprofloxacin Clinic Clinical Research Clinical Trials Clinical Trials Design Clinical trial protocol document Collaborations Complication Conductive hearing loss Contracts Cyclic GMP Deposition Development Dexamethasone Disease Drops Drug Delivery Systems Ear Ensure Environment Feedback Formulation Funding Future Goals Good Clinical Practice Hydrogels Implant Incidence Infection Injectable Institutional Review Boards Investments Manufacturer Name Medical Device Otitis Media Otology Otorrhea Pamphlets Penetration Pharmaceutical Preparations Phase Phase I Clinical Trials Phase II/III Clinical Trial Polymers Preparation Prevention Production Protocols documentation Research Personnel Risk Scientist Small Business Innovation Research Grant Sterilization Steroids Suspensions Therapeutic Therapeutic Clinical Trial Time Treatment Efficacy Tube Tympanostomy Tympanostomy Tube Insertions United States Work base compliance behavior design drug development experience hearing impairment implantation improved manufacturing scale-up meetings operation phase 1 study pre-clinical preclinical study product development scale up success vapor

项目摘要

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.

项目概要中耳炎（中耳间隙感染）是儿童最常见的疾病之一。鼓膜切开术插入鼓室置管 (TT) 是美国对儿童最常见的手术国家。耳漏是插管后最常见的并发症，高达 17% 的耳朵会发生耳漏接受 TT 并且通常与活动性感染有关。目前的治疗包括施用抗生素或抗生素/类固醇每天滴两次，持续 14 天。虽然这减少了感染的发生率，存在患者依从性和儿童暂时性传导性听力损失的问题。增强型治疗选择将提高治疗效果并提高患者的依从性。该 CRP SBIR 提案涉及准备启动长期临床试验的材料释放水凝胶以局部输送类固醇和抗生素，用于治疗 TT 相关性耳漏。这该提案的目标有三个：首先，设计和规划一期临床试验，包括完成研究者手册。其次，制定监管策略，包括编制提交 IND 的文件，与 FDA 举行 IND 前会议，并提交 IND。最后，与制造相关的技术援助，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。该项目的完成将使公司获得后续资金以完成第一阶段临床研究。 O-Ray 的研究人员团队具有执行此处提议的工作的独特资质，并且拥有成功开发该产品的耳科、药物开发和药物输送方面的专业知识。欧雷科学家们已成功开发出目前用于临床的治疗配方。这包括眼内缓释类固醇植入物，能够维持玻璃体内的抗炎作用从单次植入起，药物水平可维持长达 3 年。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。